Immunise Australia Program
Australian Government Department of Health and Ageing
Australian Government Department of Health and Ageing. Immunise Australia Program. Information Line 1800 671 811
Immunise Australia Program. Information Line 1800 671 811

The Australian Immunisation Handbook


The purpose of the Australian Immunisation Handbook is to provide clinical guidelines for health professionals on the safest and most effective use of vaccines in their practice.

The draft 10th edition of the Australian Immunisation Handbook has been developed by the Australian Technical Advisory Group on Immunisation (ATAGI) in accordance with the 2008 NHMRC Standard for Clinical Practice Guidelines. Further information on the role of the ATAGI is available at Immunisation Advisory Bodies web page.

Consultation

The period for lodgement of submissions closed at 5.00pm 15 August 2012. A total of 54 submissions were received, yielding 534 comments. ATAGI has considered the submissions and where appropriate amendments have been made to the draft handbook.

In the interest of openness and transparency details of the organisation/individuals who provided submissions and ATAGI responses are available in a printable version here.
Index of Submissions (Word 95 KB)
Index of Submissions (PDF 564 KB)
Public Consultation Responses (Excel 103 KB)
Public Consultation Responses (PDF 1338 KB)

The Department of Health and Ageing has made every effort to ensure that the Microsoft Excel version of Public Consultations Responses meets accessibility requirements. If you are experiencing difficulty accessing the information contained within this document, please email the Immune Coord to arrange for an alternative format to be provided to you.

10th Edition Australian Immunisation Handbook – Public Consultation Index of Submissions

Submission
No
NameOrganisation
1
Ms E AdamsonCancer Council, Carlton, VIC
2
Ms G AylmerWide Bay Public Health Unit, QLD Health, Hervey Bay, QLD
3
Dr K BoswardUniversity of Sydney, Sydney, NSW
4
Ms D BreadsellDarling Downs Public Health Unit, QLD Health, Toowoomba, QLD
5
Mrs K A BrussenCaroline Chisholm Centre for Health Ethics, East Melbourne, VIC
6
Mrs V BryantCommunicable Diseases Branch, QLD Health, Brisbane, QLD
7
Ms J BurrDisability and Domiciliary Care Services, Fullarton, SA
8
Ms T CabrieRoyal Melbourne Hospital, Parkville, VIC
9
Ms S Campbell-LloydImmunisation Unit, NSW Ministry of Health, North Sydney, NSW
10
Dr V CareyNovartis Vaccines & Diagnostics, North Ryde, NSW
11
Ms L CarterGlaxoSmithKline, Abbotsford, VIC
12
Mr P CashmanHunter New England Public Health Unit, Wallsend, NSW
13
Dr A ChengVictorian Spleen Registry, Melbourne, VIC
14
Ms H CookCentre for Disease Control, Darwin, NT Health
15
Ms P CowardDepartment of Justice and Attorney-General, Brisbane, QLD
16
Dr B CowieHepatitis B Program, Epidemiology Unit, Victorian Infectious Diseases Reference Laboratory, Parkville, VIC
17
Ms G CummingsNot provided
18
Dr S DangCSL Biotherapies, Broadmeadows, VIC
19
Ms S AndersonDepartment of Health & Ageing, Woden, ACT
20
Dr S DonohueTownsville Public Health Unit, Townsville, QLD
21
Prof D DurrheimUniversity of Newcastle, Callaghan, NSW
22
Mrs K ExadactylosCSL Biotherapies, Parkville, VIC
23
Dr S GabrielCentre for Population Health, Cumberland Hospital, Parramatta, NSW
24
Ms C GeorgeCentre for Population Health, Western NSW Local Health District, Dubbo, NSW
25
Dr K GibneyMonash University, Caulfield East, VIC
26
Ms S GrantSunshine Coast Public Health Unit, Maroochydore , QLD
27
Ms M GrybaitisAustralian Medical Association, Barton, ACT
28
Ms M HallPublic Health Unit, QLD Health, Brisbane, QLD
29
Mrs K HipsleyAmbulance Service of NSW, Rozelle, NSW
30
Mrs V KirbySanofi Pasteur, Macquarie Park, NSW
31
Ms S KumarThe Royal Australian & New Zealand College of Obstetricians & Gynaecologists, East Melbourne, VIC
32
Ms E MacdonaghNorth Metropolitan Area Health Service, Department of Health, East Perth, WA
33
Ms J MaclachlanMelbourne Health, Parkville, VIC
34
Dr P MasseyHunter New England Population Health, Wallsend, NSW
35
Ms S MilesAustralian Catholic University, Brisbane, QLD
36
Miss MitchellQLD Health, Brisbane, QLD
37
Ms C NagyCentre for Disease Control, Darwin, NT
38
Ms H O’DonnellCancer Council, Carlton, VIC
39
Mrs J PalmerEastern Health Authority, Adelaide, SA
40
Mr G RowlesRiddell Country Practice, Riddells Creek, VIC
41
Ms D-M SchmidtLiverpool Hospital, Liverpool, NSW
42
Ms M SmithDepartment of Human Services, Tuggeranong, ACT
43
Dr M SmithRefugee Health Network of Australia, Liverpool, NSW
44
Dr J SmithCentral Queensland Public Health Unit , QLD Health, Rockhampton, QLD
45
Dr M SmithNSW Refugee Health Service, Liverpool, NSW
46
Dr D StainesGold Coast Public Health Medical Officer, QLD Health, Robina, QLD
47
Ms C StaplesHunter New England Local Health District, Wallsend, NSW
48
Ms Z StardustScarlet Alliance, Redfern, NSW
49
Miss T-H Vo-TranPharmacy Department , The Royal Women’s Hospital, Parkville, VIC
50
Mr J WallaceLatrobe University, Melbourne, VIC
51
Miss L WalshVictorian Hepatitis B Alliance, Brunswick, VIC
52
Ms M WatsonSA Health, Adelaide, SA
53
Mrs B WilsonNSW Health, North Sydney, NSW
54
Ms S WongBaxter Healthcare Pty Ltd, Old Toongabbie, NSW


10th Edition Australian Immunisation Handbook – Public Consultation Responses

Submission No:  1-54Part No Page NoLine NoCommentsProposed ActionRationale
26Front Inside Cover1Not applicableService providers can photocopy this information to give to parents. throughout the table would you consider changing the word 'aerosols' to a more user friendly word.Chapter amended in response to commentsNot applicable
282.1 Pre-vaccination procedures192824 weeks of age is 168 days, not 164 (24 x 7 = 168).Chapter amended in response to commentNot applicable
242.1 Pre-vaccination procedures915Add "including any previously missed vaccine doses."
We frequently need to prepare catch ups for children who have turned up on their 1yr or 18 month anniversary for vaccination and the provider has not checked that child was up to date thereby giving only those due on the anniversary. I also tutor immunisation students and find that missed doses is not something that they think to check for when doing a routine pre-vaccination check.
Chapter amended in response to commentNot applicable
392.1 Pre-vaccination procedures191Minimum accepted by ACIR - Varicella at 18 months, however minimum age for first dose can be from 12 months in exceptional circumstances. So does this mean that ACIR will not accept any doses before the 18 months? Some people pay for Varicella  due to circumstances prior to the 18 months, will this effect them?Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures917Consider vaccination history but no tool to do so - suggest reference to VIC health 'Adult Immunisation Questionnaire'.Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures241Table 2.1.11
Title doses not include PPV which is in the table. Wording of last two columns of Booster doses differs, should be consistent. A number is in the column may be better to be 'needed' or 'not needed'
Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures231Table 2.1.10
Heading and content of last column on right side don't match. The column has a number but heading does not prompt a number. Should be 'needed' or 'not needed' Also requires reference to fine print for interval. 9th ed table has interval much clearer in table. Suggest trial priot to print.
Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures71Table 2.1.1
Change reference to 13vPCV in table to pneumococcal to be consistent with following tables & to allow for the different PCV vaccines people will be working with in this table.
Also separate line for PPV & PCV.
Also p20 line 24 also refer to 10vPCV - need consistency with general references to PCV vaccines.
Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures2018-20Says here needs a dose > 12 mths this is inconsistent with table 2.1.7 which has dose at 11mths is accepted.Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures727This section on cold chain much improved - well done.
Please add "why are we concerned about vaccine storage management" from p 2 strive for 5.
Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures1343Needs reference to school immunisation program and how to obtain records.Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures148Catch up calculator only useful for children not for all of life.Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures1928Last line beginning 'For infants......' suggest omit because confusing in context of previous 2 lines with doses numbered.Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures2050Table 2.1.8 Delete PRP/OMP references in table - does not add anything and complicates table unnecessarily.Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures2519Lifestyle definition is too narrow & should include behavioural and social factors ie tobacco, homeless.Chapter amended in response to commentNot applicable
122.1 Pre-vaccination procedures2547Table 2.1.12
This table omits many non scheduled vaccines for people > 10 years influenza, rabies, Q fever. We recommend a table of all vaccines recommended, this information is spread throughout and a summary needs to be in one place.
Chapter amended in response to commentNot applicable
222.1 Pre-vaccination procedures1340Please note this HPV Register information may need to be updated to include information relevant to males.Chapter amended in response to commentNot applicable
222.1 Pre-vaccination procedures141Consider addition of checking Q Fever vaccination status prior to vaccination. Chapter amended in response to commentNot applicable
222.1 Pre-vaccination procedures1433Not variation with cholera vaccination recommendations.Chapter amended in response to commentNot applicable
222.1 Pre-vaccination procedures2540Consider specifying pneumococcal vaccine (i.e. 23vPPV).Chapter amended in response to commentNot applicable
142.1 Pre-vaccination procedures231In the NT our schedule (and all our electronic recall and reminder systems) are set up for these children to receive 4 doses ie; a booster dose at
18 months regardless of whether dose 3 was given at age >12 months. On this table the last 5 options do not fit in with how we implement our schedule and will cause confusion as we will not be able to match our recall systems to this table. The same issue will result for table 2.1.11 on page 24.
No action requiredRules and tables remain.
States and territories to implement changes as required
142.1 Pre-vaccination procedures221This table is good.No action requiredNot applicable
372.1 Pre-vaccination procedures1313The previous handbook stated that catchup vaccine planning for children was <8years of age or greater than or equal to 8 years of age. there are multiple references in this section to it now being 10 years of age or more. Is this an ATAGI recommendation only? Providers need to be widely alerted to this change when the handbook is released. It impacts heavily on catchup programs.No action takenImplementation issue
372.1 Pre-vaccination procedures2545-46Inconsistent with advice from the vaccine suppliers .Chapter amended in response to commentNot applicable
402.1 Pre-vaccination procedures111Table 2.1.2
Has a severe or chronic illness does that the rationale column also need a comment explaining why significant immunocompromise should not receive live vaccines?
Chapter amended in response to commentNot applicable
402.1 Pre-vaccination procedures111Table 2.1.2
NB Advise women not to become pregnant within 28 days of receiving live a viral vaccines should be in action, not rationale.
Chapter amended in response to commentNot applicable
402.1 Pre-vaccination procedures858Just a grammar error documented in the patiens file.Chapter amended in response to commentNot applicable
402.1 Pre-vaccination procedures726There is a lack of guidance regarding transport from private pharmacy to the site of vaccination in the ' strive for 5  document, and perhaps a general description or framework of principles needs to be included in this Handbook.No action requiredComment noted
Strive for Five is to be updated so that it includes information on storage of vaccines during transport.
402.1 Pre-vaccination procedures131General comment:  Practitioners often rely upon serology when designing a catch-up vaccination program. Perhaps there needs to be a comment on the suitability of serology and its limited role in assisting in some cases and in specific diseases where serology is more reliable! e.g. varicella?Chapter amended in response to commentNot applicable
402.1 Pre-vaccination procedures1311Is the catch up calculator - being kept up to date? Will it continue to reflect the up-to-date NIP vaccines?Referred to departmentImplementation issue 
402.1 Pre-vaccination procedures1348Possibly insert !! For most vaccines (except Q fever)Chapter amended in response to commentNot applicable
402.1 Pre-vaccination procedures161Table 2.1.1
PCV rather than 13VPCV as past vaccines could have been PCV7.
Chapter amended in response to commentNot applicable
112.1 Pre-vaccination procedures111Appears to be inconsistent with bottom of page 9/top of page 10 which says 12 months.Chapter amended in response to commentNot applicable
112.1 Pre-vaccination procedures76For clarity, replace 'conjunction' with 'in accordance'. Chapter amended in response to commentNot applicable
422.1 Pre-vaccination procedures3413Please change Department of Health Services to Department of Human Services.Chapter amended in response to commentNot applicable
422.1 Pre-vaccination procedurestable 2.1.719Minimum age accepted as vailid by ACIR for MenCCV should read 6 weeks (not 11 months).
Minimum age accepted as valid by ACIR for Varicella should read 12 months (not 18 months).
Chapter amended in response to commentNot applicable
272.1 Pre-vaccination procedures740As not all vaccinations are provided by a vaccine recipients regular GP, for the purposes of continuity of care and accurate patient records, if a vaccination is provided by a vaccination provider other than the patiets regular GP, the recipient should be asked to nominate their regular GP and a record of the vaccinations received provided to that GP.  No action requiredSection on vaccine records has been up-dated.
In general however this comment is addressed in other guidelines and not in the scope of this handbook.
372.1 Pre-vaccination procedures81 Updated references in consent section (ref JL paper) as well as definition for consent.Chapter amended in response to commentNot applicable
72.2 Administration of vaccines3036-37Wording needs to be consistent with Hand Hygiene Australia (ie decontaminate hands by either washing with soap and water or using alcohol based hand rub).Chapter amended in response to commentNot applicable
122.2 Administration of vaccines3530Remove reference to infection.Chapter amended in response to commentNot applicable
352.2 Administration of vaccines3430-31This section should state the rationale for using the vastus lateralis in infants under 12 months of age, so please add "as this is the largest muscle in infants of this age" to the end of line 31.Chapter amended in response to commentNot applicable
352.2 Administration of vaccines281For pages 28-43 and For all sections in this part and in all parts, it is important to state a brief rationale as this increases compliance with the required / recommended procedure. It would be ideal to state a rationale for site and route of injection, size of needles, administration procedures etc.Chapter amended in response to commentNot applicable
352.2 Administration of vaccines411This section should specify what to do for administering two injectable vaccines on the one visit, because this section is currently confusing and would seem to suggest using one leg or one leg and the ventrogluteal area. Most clinics administer one vaccine in each anterolateral thigh (each leg) and document which vaccine was given in which leg to be able to identify any adverse reactions.Chapter amended in response to commentNot applicable
352.2 Administration of vaccines335It would be good to add "and increased likelihood of local reaction at the injection site" to the end of line 5 as this has been shown to happen with tracking of alcohol into the subcutaneous layers.Chapter amended in response to commentNot applicable
352.2 Administration of vaccines3123-24This section does state that the needle is changed after drawing up. So Lines 23 and 24 are correct here and contradict the Section above on Lines 10 and 11 about not needing to change the needle after drawing up. It would be good to add at the end of line 24: "to reduce local adverse reactions".Chapter amended in response to commentNot applicable
352.2 Administration of vaccines311Research by Diggle and others has shown an increase in local reactions if any vaccine is on the needle after drawing up or expelling through the needle. The statement should state that it IS necessary to change the needle after drawing up from an ampoule to lessen the likelihood of adverse reactions at the injection site. Best practice is to have a clean needle and to not expel any vaccine through the giving needle.Chapter amended in response to commentNot applicable
222.2 Administration of vaccines3337-39Merieux (rabies vaccine HDCV) recommendations here  conflict with Table 2.2.1 (page 32 line 8) which shows that Merieux can be given SC or IM. Note, in some circumstances SC administration of hepatitis B is recommended as per Product Information.Chapter amended in response to commentNot applicable
222.2 Administration of vaccines328Change JEspect to JESPECT throughout Handbook as per Product Information.DisagreeEditorial decision
122.2 Administration of vaccines4529Only says to give adrenalin if diagnosis is unclear. Suggest - If anaphylaxis is considered administer adrenaline. If diagnosis is unclear administer adrenaline. Chapter amended in response to commentNot applicable
122.2 Administration of vaccines4431Wording should be corrected and state 'most vaccines adverse event are minor' .Chapter amended in response to commentNot applicable
122.2 Administration of vaccines402013v PCV associated with increased pain - please omit - is on PI in reference to 7vPCV - not helpful info to providers will confuse them about where to give vaccine etc. Chapter amended in response to commentNot applicable
302.2 Administration of vaccines328Table 2.2.1- for the IM or SC injection column. They key affixed to influenza vaccine should ideally read 'The IM route is preferred over the SC route because it causes fewer local adverse events'.Chapter amended in response to commentNot applicable
402.2 Administration of vaccines316Is sterility of rubber bungs guaranteed? USA guidelines suggest cleansing vaccine vials with alcohol and letting it dry, as do a number of Australian Product Information for non-vaccine therapeutics.Chapter amended in response to commentText amended to state if there is visible contamination then the bung can be cleaned with a clean, single-use swab allowing time to dry before vaccine injection.
402.2 Administration of vaccines287Gloves are not routinely recommended for immunisation service providers, I suggest that this sentence could be completed with unless the person administering the vaccine is likely to come into contact with body fluids or has open lesions on the hands, and the following line of if exposure does occur, guidelines for post exposure prophylaxis should be followed should be inserted prior to the sentence on gloves.Chapter amended in response to commentNot applicable
122.3 Post-vaccination 4436An important factors in reducing suggest change factor to singular.Chapter amended in response to commentNot applicable
172.3 Post-vaccination 4926Reporting adverse events following vaccination is not easy. Information is not readily available. This discourages reporting. I had an experience of trying to report following an adverse reaction in an adult following MMR. Patient attended local hospital and was told 'it was nothing to worry about'. Rang vaccination centre and was told to see GP. Patient visited GP and was diagnosed with Rubella contracted from vaccination. The patient meanwhile had been out and about in the community with active disease. Health organisations are not proactive about reporting.No action requiredReporting of adverse events is discussed in handbook.
Individual practise issues not all within scope of Handbook
172.3 Post-vaccination 459Observation after vaccination is not commonly carried out. Parents generally leave following immunisation and are not always advised to remain in the vicinity for 10-15 mins. A simple card or diagram on a card for those who are not literate would be useful.No action required Discussed in handbook. Practise issue and not all within scope of Handbook
222.3 Post-vaccination 4836Reference 9 does not state rate of 9 per 1000 but has a link to a TGA report dated 24 September 2010. This report states under epidemiological analyses a rate of 9 per 1000. Note, a later dated report released by TGA on 4 Oct 2010 states a rate of 7 per 1000 under epidemiological analyses.  This 7 per 1000 rate is also consistent with the literature cited in the influenza chapter (4.7). Ref 77 Mahajan D et al. Communicable Disease Intelligence 2011, which states a rate of 500-700 per 100,000 (5-7 per 1000).Chapter amended in response to commentNot applicable
222.3 Post-vaccination 5120Please note this HPV Register information may need to be updated to include information relevant to males.Chapter amended in response to commentNot applicable
222.3 Post-vaccination 485Correct 100mg to 1000mg.Chapter amended in response to commentNot applicable
222.3 Post-vaccination 4840-42Reference 10 does not support an brachial neuritis incidence of approximately 1 in 100 000 following HPV vaccination. Chapter amended in response to commentNot applicable
122.3 Post-vaccination 4840Further down for HHE & GBS it gives indication for long term outcome but no mention here for brachial of long term outcome.No action requiredEvidence for long term outcome post-vaccination is variable. Detail not included
122.3 Post-vaccination 4636Change to full documentation should include... ie current wording limits what should be documented. Chapter amended in response to commentNot applicable
122.3 Post-vaccination 511Documentation for children & adults should be the same, with addition of acir for children. Chapter amended in response to commentNot applicable
122.3 Post-vaccination 4926Please indicate at the beginning who to report to. Chapter amended in response to commentNot applicable
122.3 Post-vaccination 4926Please indicate at the beginning who to report to. Chapter amended in response to commentNot applicable
402.3 Post-vaccination 4619I am not sure that the sequence of the management of anaphylaxis is consistent with Australian Resuscitation Council or ASCIA guidelines:
" calling for assistance could occur immediately after administration of I M adrenaline, and certainly before administration of oxygen.
" Line 33, could be more simply stated as  check breathing and pulse, if absent commence Basic Life Support or appropriate CPR
" line 20, could be strengthened, possibly adapting this comment from ASCIA Adrenaline is life saving and must be used promptly. Withholding or delaying the giving of adrenaline can result in deterioration and death. This is why giving the adrenaline autoinjector is the first instruction on the ASCIA Action Plan for Anaphylaxis. If cardiopulmonary resuscitation (CPR) is given before this step there is a risk that adrenaline is delayed or not given.
Chapter amended in response to commentNot applicable
112.3 Post-vaccination 4829-31The association of increased rate of febrile convulsions is seen after the first measles containing dose.  Suggest draft amended text - Febrile convulsions are a rare AEFI in young children. For example, MMR and MMRV vaccines are associated with an increase in the rate of febrile convulsions occurring approximately 7-12 days post vaccination following the first dose of measles containing vaccine at the peak of vaccine virus replication.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 2651Replace Department of Health Services Australia with Department of Human Services.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 42 & 4351Replace via Medicare Australia's on-line claiming facility, Internet Electronic Data Interchange (IEDI) on the internet, with via Medicare Online or the ACIR secure internet site.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 4951Replace Medicare Australia with the Department of Human Services.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 4951Replace Medicare Australia with the Department of Human Services.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 652Replace Medicare Australia with the Department of Human Services.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 1352Remove the words Medicare Australia's from the sentence.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 1552Replace Medicare Australia with the Department of Human Services. Chapter amended in response to commentNot applicable
422.3 Post-vaccination 1652Remove the words (free call).Chapter amended in response to commentNot applicable
422.3 Post-vaccination 1952Replace and those that may be missing with and the vaccines that are next due.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 1952Remove the number 2 from the sentence. It should read when a child turns 18 months and 5 years of age.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 3052Remove all the text from the 2nd dot point.Chapter amended in response to commentNot applicable
422.3 Post-vaccination 3052Remove all the text from the 2nd dot point.Chapter amended in response to commentNot applicable
272.3 Post-vaccination 4421-23As per the comment made for Chapter 2.1.5, page 15, and line 40. If a vaccination is provided by a vaccination provider other than the patients regular GP the recipient should be asked to nominate their regular GP and a record of the vaccinations received provided to that GP.  No action requiredSection on vaccine records updated  in general however this comment is addressed in other guidelines and is not in the scope of this handbook
503.1 Vaccination of Aboriginal and Torres Strait Islander people5826Given the rationale, it seems logical that Aboriginal and Torres Strait Islander adults be recommended for hepatitis B vaccination given the higher prevalence of the infection within these communities.  Chapter amended in response to commentNot applicable
333.1 Vaccination of Aboriginal and Torres Strait Islander people5851Aboriginal and Torres Strait Islander adults should also be recommended for Hepatitis B vaccination. As stated in Section 4.5 Aboriginal and Torres Strait Islander people have a prevalence of chronic hepatitis B, and incidence of acute hepatitis B much higher than the general population, a risk that is of the same or greater magnitude as many other groups recommended for hepatitis B vaccination.Chapter amended in response to commentNot applicable
333.1 Vaccination of Aboriginal and Torres Strait Islander people5851Aboriginal and Torres Strait Islander adults should also be recommended for Hepatitis B vaccination. As stated in Section 4.5 Aboriginal and Torres Strait Islander people have a prevalence of chronic hepatitis B, and incidence of acute hepatitis B much higher than the general population, a risk that is of the same or greater magnitude as many other groups recommended for hepatitis B vaccination.Chapter amended in response to comment - duplicate comment 2Not applicable
333.1 Vaccination of Aboriginal and Torres Strait Islander people5851Aboriginal and Torres Strait Islander adults should also be recommended for Hepatitis B vaccination. As stated in Section 4.5 Aboriginal and Torres Strait Islander people have a considerably higher prevalence of chronic HBV and incidence of acute HBV, a risk of the same or greater magnitude as many other groups recommended for hepatitis B vaccination. Chapter amended in response to comment - duplicate comment 2Not applicable
333.1 Vaccination of Aboriginal and Torres Strait Islander people5851Aboriginal and Torres Strait Islander adults should also be recommended for Hepatitis B vaccination. As stated in Section 4.5 Aboriginal and Torres Strait Islander people have a considerably higher prevalence of chronic HBV and incidence of acute HBV, a risk of the same or greater magnitude as many other groups recommended for hepatitis B vaccination. Chapter amended in response to comment - duplicate comment 2Not applicable
163.1 Vaccination of Aboriginal and Torres Strait Islander people5851Vaccination against hepatitis B should be recommended for all Aboriginal and Torres Strait Islander Australians who are susceptible to infection. Prior to vaccination, it should be recommended that all patents be tested for existing immunity or chronic HBV infection, in line with the draft National Hepatitis B Testing Policy. In the Kirby Aboriginal and Torres Strait Islanded BBV and STI surveillance report (accessibly form page 29-32) Aboriginal and Torres Strait Islander people are estimated to have 3-5 times the rate of incident HBV infection as do non-Indigenous Australians every year, across all age groups and areas of residence (urban through to remote). This increased risk of infection, plus the higher prevalence of other chronic liver diseases (which is more common among Aboriginal and Torres Strait Islander people) justify inclusion of hepatitis B vaccination for all susceptible Indigenous people.Chapter amended in response to commentNot applicable
513.1 Vaccination of Aboriginal and Torres Strait Islander people5851Aboriginal and Torres Strait Islander adults should also be recommended for Hepatitis B vaccination. As stated in Section 4.5 Aboriginal and Torres Strait Islander people have a considerably higher prevalence of chronic HBV and incidence of acute HBV, a risk of the same or greater magnitude as many other groups recommended for hepatitis B vaccination.Chapter amended in response to comment - duplicate comment 2Not applicable
223.1 Vaccination of Aboriginal and Torres Strait Islander people5756Suggest changing 'previously available' to 'previously utilised'. Liquid PedvaxHIB is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no Liquid PedvaxHIB used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL has recently submitted a response for Haemophilus influenzae type B vaccine (12 month cohort) Request for Tender.Chapter amended in response to commentNot applicable
223.1 Vaccination of Aboriginal and Torres Strait Islander people5756Suggest changing 'previously available' to 'previously utilised'. Liquid PedvaxHIB is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no Liquid PedvaxHIB used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL has recently submitted a response for Haemophilus influenzae type B vaccine (12 month cohort) Request for Tender.Chapter amended in response to commentNot applicable
143.1 Vaccination of Aboriginal and Torres Strait Islander people5832-381st sentence (at end of line 33) should read; from July 2011 except in the Northern Territory. Commencing line 35 should read; initially replaced by a 4-dose schedule of 10-valent.....(10vPCV) in October 2009 and then 13vPCV replaced the 3-dose infant schedule from October 2011. A booster dose of 13vPCV were also recommended....Chapter amended in response to commentNot applicable
143.1 Vaccination of Aboriginal and Torres Strait Islander people5846If this is not the first reference to invasive pneumococccal disease therefore it should be IPD. Tables on page 22-24 refer to IPD.Chapter amended in response to commentNot applicable
373.1 Vaccination of Aboriginal and Torres Strait Islander people595"at least 8 times higher and deaths 20 times higher"   - than what??? Needs clarification.Chapter amended in response to commentNot applicable
373.1 Vaccination of Aboriginal and Torres Strait Islander people5914The first sentence states that pnuemococcal vaccine has been expanded to ALL adults aged greater than or equal to 50 years. This statement is either wrong or misleading in the way it has been written.Chapter amended in response to commentNot applicable
373.1 Vaccination of Aboriginal and Torres Strait Islander people5914The first sentence states that pnuemococcal vaccine has been expanded to ALL adults aged greater than or equal to 50 years. This statement is either wrong or misleading in the way it has been written.Chapter amended in response to commentNot applicable
163.1 Vaccination of Aboriginal and Torres Strait Islander people5851Vaccination against hepatitis B should be recommended for all Aboriginal and Torres Strait Islander Australians who are susceptible to infection. Prior to vaccination, it should be recommended that all patients be tested for existing immunity or chronic HBV infection, in line with the draft National Hepatitis B Testing Policy. In the Kirby Aboriginal and Torres Strait Islander BBV and STI surveillance report - page 29-32 Aboriginal and Torres Strait Islander people are estimated to have 3-5 time the rate of incident HBV infection as do non-Indigenous Australians every year, across all age groups and areas of residence (urban through to remote). This increased risk of infection, plus the higher prevalence of other chronic liver diseases (which is more common among  Aboriginal and Torres Strait Islander people) justify inclusion of hepatitis B vaccination for all susceptible Indigenous people.Chapter amended in response to comment - duplicate comment 5Not applicable
13.1 Vaccination of Aboriginal and Torres Strait Islander people5851Aboriginal and Torres Strait Islander adults should also be recommended for Hepatitis B vaccination. As stated in Section 4.5 Aboriginal and Torres Strait Islander people have a considerably higher prevalence of chronic HBV and incidence of acute HBV. Chapter amended in response to commentNot applicable
273.1 Vaccination of Aboriginal and Torres Strait Islander people605Culturally appropriate service delivery and communication strategies will also assist in lifting rates of immunisation for Indigenous Australians. Chapter amended in response to commentNot applicable
223.2 Vaccination for International travel691Suggest addition of HPV vaccination to table 3.2.1. This may be appropriate to include under 'vaccines for selective use in travellers'.DisagreeHPV vaccination is not applicable in this table
223.2 Vaccination for International travel691Table 3.2.1 Measles-mumps-rubella. Please include M-M-R-II 0.5mL SC.
M-M-R-II is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no M-M-R-II used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL intends to submit a response for
M-M-R-II when the measles, mumps and rubella Request for Tender is issued later this year.
Chapter amended in response to commentNot applicable
223.2 Vaccination for International travel675As per the Dukoral Product Information, clinical results have revealed a protective efficacy against cholera of 85 per cent for the first six months in all age categories although efficacy had fallen to 52 per cent at the end of the second year.Chapter amended in response to commentNot applicable
223.2 Vaccination for International travel7210Under comments for Typhoid, suggest to note that Vivotif Oral capsules must be swallowed whole and cannot be chewed.Chapter amended in response to commentNot applicable
223.2 Vaccination for International travel702Change JEspect to JESPECT throughout Handbook as per Approved Product Information. DisagreeEditorial decision
223.2 Vaccination for International travel702Change JEspect to JESPECT throughout Handbook as per Approved Product Information. DisagreeEditorial decision
223.2 Vaccination for International travel6725-27Suggest that 'Vaccination is recommended for travellers spending a month or more in rural areas of endemic regions, particularly if travel is during the wet season and or there is considerable outdoor activity and or accommodation is inadequately screened against mosquitoes' be changed to 'Vaccination is recommended for travellers spending a month or more in rural areas of endemic regions and should be considered for shorter term travellers, particularly if travel is during the wet season and or there is considerable outdoor activity and or accommodation is inadequately screened against mosquitoes'.Chapter amended in response to commentNot applicable
113.2 Vaccination for International travel170The current WHO recommendation is to vaccinate against hepatitis A when travellers are going from countries of low endemicity to countries with intermediate-high endemic levels of hepatitis A.  With this in mind, suggest moving the list of hepatitis-A containing vaccines from the section titled "Vaccines for selective use in travellers" to the section above titled "Routinely recommended vaccines" for travellers.Chapter amended in response to commentNot applicable
323.3 Groups with special vaccination requirements953States those born prior to 1966 are immune to measles.What about mumps and rubella?Should HCW not be mmune to these also?Chapter amended in response to commentNot applicable
133.3 Groups with special vaccination requirements9036We note that the guidelines for asplenia for meningococcal and pneumococcal vaccination are similar to the US ACIP guidelines. We were wondering if the evidence for hyporesponsiveness for PS vaccines is strong enough to justify a 30-40 year gap in boosters?
The recommendation for pneumococcal vaccine is 1 dose primary PS23 followed by booster at 5 years then at 65 years of age - ie for the 20 year old who loses his spleen in a car crash, it will be 40 years between 2nd and 3rd dose.
The recommendation for meningococcal vaccine is 2 dose primary 4vMenCV followed by booster every 5 years - ie by 65 years, this same patient will have received 9 boosters after the 2 dose primary course.
Chapter amended in response to commentText reviewed and updated taking the comment into account. More detailed information on 23vPPV recs for splenectomy included here and in pneumococcal chapter. Also addtion of single dose of 13vPCV for this risk group.
133.3 Groups with special vaccination requirements9036We note there are at least some papers that suggest that patients revaccinated after 6-9 years do not have evidence of hyporesponsiveness (Davidson Arch Intern Med, 154 (1994), pp. 2209-2214). We presume the handbook will be updated with the upcoming CAPITA study of PCV13 in adults, but we note that this study will only include adults >65 years and patients not previously vaccinated or immunosuppressed (which presumably will exclude asplenic patients).No action requiredInformation included in handbook
133.3 Groups with special vaccination requirements9036We note there are at least some papers that suggest that patients revaccinated after 6-9 years do not have evidence of hyporesponsiveness (Davidson Arch Intern Med, 154 (1994), pp. 2209-2214). We presume the handbook will be updated with the upcoming CAPITA study of PCV13 in adults, but we note that this study will only include adults >65 years and patients not previously vaccinated or immunosuppressed (which presumably will exclude asplenic patients).No action requiredInformation included in handbook
133.3 Groups with special vaccination requirements9036We were also wondering whether there is any evidence for hyporesponsiveness with frequent conjugate vaccines? We note that this may be an issue with meningococcal serotype C (Khalil M, Al-Mazrou Y,
Bravo C et al. Response to quadrivalent meningococcal conjugate vaccine in Saudi Arabian children who previously received 2 doses of quadrivalent meningococcal polysaccharide vaccine before 2 years of age. Presented at: 10th Meeting of the European Meningococcal Disease Society (EMGM). Manchester, UK, 17-19 June 2009; cited in Poolman Expert Rev Vaccines. 2011 Mar;10(3):307-22) and pneumococcal serogroup 3 (Pediatr. Infect. Dis. (2004) J23(11),1008-1014), but not HIb.
No action requiredNo substantial evidence to support amendment to date. Recommend-
ation unchanged
133.3 Groups with special vaccination requirements9036We were also wondering as to the significance of the choice of 4vMenCV vaccine? There are some immunogenicity data that Menveo is more immunogenic than Menactra. Gill (Hum Vaccin. 2010 November; 6(11):
881-887) found that seroprotection (hSBAe8) was higher at 22 months with Menveo than Menactra for serogroups A, W135 and Y. This is consistent with the phase 3 licencing studies showing immunogeneicity of Menveo (Jackson Clin Infect Dis. 2009 Jul 1;49(1):e1-10; Reisinger Clin Vaccine Immunol.
2009 Dec;16(12):1810-5) Should these data be reflected in the guidelines?
Chapter amended in response to commentNot applicable
133.3 Groups with special vaccination requirements9036We would suggest a table detailing recommended vaccines for asplenic persons, similar to those for other immunocompromised patients.Chapter amended in response to commentNot applicable
133.3 Groups with special vaccination requirements9056Page 90, line 56 implies that only children <5 years require penicillin prophylaxis; most recommendations including Therapeutic Guidelines and those of the VSR recommend antibiotic prophylaxis (penicillin, amoxicillin or other agents in patients with serious penicillin allergies) for at least 2-3 years.Chapter amended in response to commentNot applicable
133.3 Groups with special vaccination requirements9055Page 90, line 55 should also mention the recommendation that patients have an emergency supply of antibiotics.Chapter amended in response to commentNot applicable
133.3 Groups with special vaccination requirements9055Page 90, line 55 should also mention the recommendation that patients have an emergency supply of antibiotics.Chapter amended in response to commentNot applicable
133.3 Groups with special vaccination requirements913Page 91, line 3 should mention that the primary doses of 4vMenCV should be at least 8 weeks apart.Chapter amended in response to commentNot applicable
323.3 Groups with special vaccination requirements931In the table recommending vaccines it states MMR (if not immune)
Specify not immune to what is it measles, mumps and rubella or just measles?
Chapter amended in response to commentNot applicable
73.3 Groups with special vaccination requirements940In table 3.3.6 Under Carers: Feedback from Disability Services Managers is that Carers of people with intellectual disabilities is not the correct terminology. It should actually state that carers of clients with a disability rather than single out a small proportion of people. The rationale being that the clients that have other disabilities (such as brain injuries, physical disabilities, etc) are just as likely or possibly more likely to put staff at risk of a blood or body fluid exposure. Therefore all of these carers should be recommended to have the same vaccines. MMR and Varicella vaccines should also be recommended for carers of persons with disabilities, staff of nursing homes, home care and other long term care facilities (ie same as HCWs).Chapter amended in response to commentNot applicable
503.3 Groups with special vaccination requirements969,-11Consistency throughout the document in the use of 'people who inject drugs' rather than 'injecting drug users' is needed. Chapter amended in response to commentNot applicable
153.3 Groups with special vaccination requirements741Is there a need to include vaccination recommendations for persons working in places of detention and immigration centres? For example, the Royal College of Physicians in the UK recommends varicella vaccination for non-immune staff working in prisons, places of detention and immigration removal centres (Ref: page 6 of Varicella zoster virus guideline.Chapter amended in response to commentNot applicable
153.3 Groups with special vaccination requirements9439The 'working with animals' section should include a recommendation for
Q fever vaccination of wildlife and zoo workers who have contact with at-risk animals, including kangaroos and bandicoots, given that these are known to be reservoirs of infection.
Chapter amended in response to commentNot applicable
153.3 Groups with special vaccination requirements9339Table 3.3.6 As per comment 1, the term 'early childhood education and care' is now more commonly used than 'childcare and preschool'. The same comment applies to the use of 'childcare and pre-school' on pages 93 and 94. Chapter amended in response to commentNot applicable
383.3 Groups with special vaccination requirements9530Would like to see inclusion of a statement around immigrants/refugees to be encouraged to participate, where applicable, in NIP funded adolescent school immunisation programs. Anecdotally there appears to be some misunderstanding that the infant catch-up covers all immunisation and therefore adolescent immunisation is not necessary.  Chapter amended in response to commentNot applicable
343.3 Groups with special vaccination requirements941Table 3.3.6.
In regard to occupational risk of VPDs for people who work with animals.
Either as a footnote to this table or elsewhere it would be handy for the Handbook to have links to information about animal vaccinations esp livestock. There are many overlap issues One Health approach to VPDs. Suggested sites from DAFF are:
Animal Pests and Diseases
Veterinary Vaccines
Chapter amended in response to commentNot applicable
493.3 Groups with special vaccination requirements801Is there a reason why the varicella-zoster vaccine is separated into two components in the table? Also, there is no zoster-only vaccine commercially available, so why is there a separate entry? No action requiredThere are two different vaccines so the vaccines are included separately.
493.3 Groups with special vaccination requirements801Is there a reason why the varicella-zoster vaccine is separated into two components in the table? Also, there is no zoster-only vaccine commercially available, so why is there a separate entry? No action requiredThere are two different vaccines so the vaccines are included separately.
493.3 Groups with special vaccination requirements791The Japanese encephalitis vaccine Imojev(R) is not available in Australia. However the inactivated form, Jespect(R) made by CSL is available. Is there a reason why this vaccine has not been added to the table?No action requiredInformation included in handbook
493.3 Groups with special vaccination requirements771Is the influenza vaccine containing the H1N1 strain considered the same as the influenza vaccine?No action requiredInformation included in handbook
513.3 Groups with special vaccination requirements961Consistency throughout the document in the use of 'people who inject drugs' rather than 'injecting drug users' is required. Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements959Suggest: Vaccination status is not routinely assessed in children and adults entering Australia as refugees or migrants, although hepatitis B serology is recommended as part of (voluntary) post arrival health screening in refugees, and rubella serology may be performed in women of child bearing age. Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements959Suggest: Vaccination status is not routinely assessed in children and adults entering Australia as refugees or migrants, although hepatitis B serology is recommended as part of (voluntary) post arrival health screening in refugees, and rubella serology may be performed in women of child bearing age. Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements9510" Suggest: Migrants from resource poor settings, and refugees in particular, may be incompletely vaccinated according to the Australian schedule, or have incomplete immunisation records. Over 90% of refugees arriving in Australia are inadequately immunised.1,2 Catch-up immunisation is a priority in post arrival refugee health care, and should be completed in all age groups (see Tables).
1. Johnston V, Smith L, Roydhouse H. The health of newly arrived refugees to the Top End of Australia: results of a clinical audit at the Darwin Refugee Health Service (in press). Australian Journal of Primary Health 2011.
2. Tiong AC, Patel MS, Gardiner J, Ryan R, Linton KS, Walker KA, et al. Health issues in newly arrived African refugees attending general practice clinics in Melbourne. Medical Journal of Australia 2006;185(11-12):602-606
3. Phillips CB, Benson J. Better primary health care for refugees - catch up immunisation. Australian Family Physician 2007;36(6):440-2, 44.
Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements9511Immunisation records, where available for refugees, are likely to have been given to the nominated head of household & This sentence is not useful or necessary, and should be deleted.Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements9515-18Most state and territories provide immigrant/refugee immunisation through hospital outpatient departments :
" This is incorrect. In fact,  most are delivered through community-based services (Vic, SA, WA, Qld, NSW, NT)
" Next 2 sentences (starting with  Some clinics..  and  In addition.. ) are not necessary, suggest delete.
" Suggest replace above 3 sentences with: There is no systematic immunisation provided for refugees/migrants after arrival. Provision of catch-up immunisation depends on primary care services in most jurisdictions. There are challenges in delivering catch-up vaccinations to mobile populations and in maintaining records in older children, adolescents and adults. It is important to ensure that families are provided with a written record of all vaccines administered.
Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements9515-18Most state and territories provide immigrant/refugee immunisation through hospital outpatient departments :
" This is incorrect. In fact,  most are delivered through community-based services (Vic, SA, WA, Qld, NSW, NT)
" Next 2 sentences (starting with  Some clinics..  and  In addition.. ) are not necessary, suggest delete.
" Suggest replace above 3 sentences with: There is no systematic immunisation provided for refugees/migrants after arrival. Provision of catch-up immunisation depends on primary care services in most jurisdictions. There are challenges in delivering catch-up vaccinations to mobile populations and in maintaining records in older children, adolescents and adults. It is important to ensure that families are provided with a written record of all vaccines administered.
Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements9519It is important to take into account any live attenuated viral vaccines that may have been administered. " Worth noting specifically that the (voluntary) Departure Health Check (DHC) for Humanitarian entrants now includes MMR for those aged
9m- 54 years; note recently extended upper age limit (from 30 to 54). This is not yet updated on the DIAC website, but is policy and practice since mid-2012  [personal communication, Dr Paul Douglas, Chief Medical Officer, DIAC].
" Live viral vaccines also affect interpretation of Tuberculin Skin Tests, often forgotten in refugee health".
" Suggest: It is important to take into account any live attenuated viral vaccines that may have been administered, such as yellow fever vaccine in arrivals from Central/North Africa. Also, the (voluntary) Departure Health Check (DHC) for Humanitarian entrants now includes MMR for those aged 9 months to 54 year. This should be considered when planning catch-up vaccination, and also when undertaking tuberculin.
Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements9523"If an immigrant has no valid documentation of vaccination a standard catch-up schedule should be commenced.":
" Suggest: If a migrant has no valid written documentation of vaccination, a standard catch-up schedule should be commenced. Consider pregnancy in females of childbearing age.
Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements9531Some refugees aged between 9 months and 30 years may have been offered MMR as part of a pre-departure screen but may require a subsequent dose :
This age limit has been increased to 54 (see above re line 19)".
Suggest: Refugees aged 9months to 54 years may have had MMR vaccination as part of a health check just prior to their departure, but may require a subsequent dose.
Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements958Heading 3.3.8. Suggest use migrants instead of immigrants (and continue throughout).Chapter amended in response to commentNot applicable
433.3 Groups with special vaccination requirements958Heading 3.3.8. Suggest use migrants instead of immigrants (and continue throughout).Chapter amended in response to commentNot applicable
143.3 Groups with special vaccination requirements8443It is not clear what the sentence 'Pneumococcal booster vaccinations.... ' means. It refers to chapter 4.13 but only table 4.13.2  refers to booster doses. Need to either label doses as booster doses in table 4.13.1 and 4.13.3 as well or change the wording of this sentence.Chapter amended in response to commentNot applicable
143.3 Groups with special vaccination requirements8423If the recommendation on line 10 on page 84 is followed (vaccinate as early as possible after diagnosis) then most persons recommended for 23vPPV would have had a dose of 23vPPV within the previous 5 years.  Chapter amended in response to commentNot applicable
143.3 Groups with special vaccination requirements8543Table 3.3.2 comments for 13vPCV section very complicated. Not sure how to simplify though.Chapter amended in response to commentNot applicable
143.3 Groups with special vaccination requirements8724Should this include the word 'conjugate' before pneumococcal?No action requiredIt would be incorrect to include the word conjugate in this sentence.
143.3 Groups with special vaccination requirements8732Table 3.3.3.  Title should say 'recommendations for revaccination following HSCT regardless of previous immunisation history'. Also the 2 pneumococcal sections do not specify what ages these refer to. Is the 13vPCV recommendation for 3 doses for age <2 or up to age <18?Chapter amended in response to commentNot applicable
373.3 Groups with special vaccination requirements8133Preterm infants (<36 weeks gestation) Does the gestational age need to be recorded here? If the reader was looking for specific vaccine recommendations for preterm infants would this additional text be confusing or add benefit? Is this the standard definition for preterm.Chapter amended in response to commentNot applicable
373.3 Groups with special vaccination requirements958Suggest including the word Refugee in the title as the text refers to both immigrants and refugees ( a more commonly used word in today's health context).Chapter amended in response to commentNot applicable
373.3 Groups with special vaccination requirements958Suggest including the word Refugee in the title as the text refers to both immigrants and refugees ( a more commonly used word in today's health context).Chapter amended in response to commentNot applicable
263.3 Groups with special vaccination requirements9139-48Would you mind clarifying this section (functional or anatomical asplenia) with the cross reference to the Meningococcal chapter p183 line 39 to 48 and p184 line 17 to 20. It's not easy to read and could lead to errors particularly if involving a infant < 12 mths at risk for meningococcal disease. For example have I misinterpreted a scenario where an at risk 8 mth old infant is commenced on MenCCV at 8mths - are you then  recommending  4vMenCV be given at 10 mths then repeat at 12 months therefore I'm assuming not requiring a booster dose of MenCCV usually scheduled at 12 mths? It seems as though there could be occasions where the MenCCV recommendations could overlap with the 4vMenCV recommendations in infants, probably due to the 4vMenCV being recommended from 9mths of age. ( p91 line 3) For user convenience suggest inserting the spacing recommended between dose 1 & 2 of 4vMenCV-  '2 doses of 4vMenCV given 8 weeks apart with a booster every 5 years'.Chapter amended in response to comment A table was also added for asplenic patient immunisation recommend-
ations
263.3 Groups with special vaccination requirements9018-20Recommendation is for pH1N1 containing vaccine. Will this strain be available in influenza vaccine for the life of this edition?Chapter amended in response to commentNot applicable
83.3 Groups with special vaccination requirements9530Immigrants and refugees should also be targeted for Hepatitis B vaccination as many come from countries with up to 10% hepatitis B prevalence, such as parts of Africa and South East Asia. Screening before vaccination would be mandatory in this population group to exclude that they don't already have chronic hepatitis B.Chapter amended in response to commentNot applicable
233.3 Groups with special vaccination requirements860table 3.3.3 age recommendations for HPV vaccine are not clear. Is there an upper age limit?Chapter amended in response to commentNot applicable
233.3 Groups with special vaccination requirements860table 3.3.3 age recommendations for HPV vaccine are not clear. Is there an upper age limit?Chapter amended in response to commentNot applicable
233.3 Groups with special vaccination requirements9155-56When hyperimmune globulin is used against a specific infection, such as varicella, vaccination against other live viruses need not be deferred. There seems to be discrepancy between the above information and table page 92,  ZIG where 5 months interval is recommended.Chapter amended in response to commentNot applicable
13.3 Groups with special vaccination requirements969Recommend that the term "people who inject drugs" to be consistently used within this document and to be consistent with other government policies/guidelines.Chapter amended in response to commentNot applicable
13.3 Groups with special vaccination requirements95Table
3.3.6
People born in endemic areas should be included as a recommended group for hepatitis B vaccination. Vaccination should also following serological testing.  The majority of chronic hepatitis B cases in Australia are seen in culturally and linguistically diverse (CALD) communities from countries where hepatitis B is endemic. Up to 1/3 of chronic hepatitis B cases in Australia are undiagnosed. If immigrants/refugees are not screened first, then it is not known if they already have chronic hepatitis B. If they have chronic hepatitis B, then the vaccination will only be useful for household contacts and/or sexual contacts.Chapter amended in response to commentNot applicable
13.3 Groups with special vaccination requirements95Table
3.3.6
People born in endemic areas should be included as a recommended group for hepatitis B vaccination. Vaccination should also following serological testing.  The majority of chronic hepatitis B cases in Australia are seen in culturally and linguistically diverse (CALD) communities from countries where hepatitis B is endemic. Up to 1/3 of chronic hepatitis B cases in Australia are undiagnosed. If immigrants/refugees are not screened first, then it is not known if they already have chronic hepatitis B. If they have chronic hepatitis B, then the vaccination will only be useful for household contacts and/or sexual contacts.Chapter amended in response to commentNot applicable
313.3 Groups with special vaccination requirements7548-60RANZCOG Recommendation:
The WHC, on behalf of RANZCOG, would like to request that the Department of Health and Ageing consider making similar recommendations to the CDC and ACOG in the 10th Edition of the Australian Immunisation Handbook.
Chapter amended in response to commentATAGI's decision  at this stage is that there is insufficient evidence to recommend routine vaccination of pregnant women with dTpa. However, text has been amended to improve clarity that vaccin-
ation during pregnancy is anacceptable alternative option, and also to provide option of shorter interval for dTpa in context of pregnancy (in 3.3 and pertussis chapter).
313.3 Groups with special vaccination requirements7548-60RANZCOG Recommendation:
The WHC, on behalf of RANZCOG, would like to request that the Department of Health and Ageing consider making similar recommendations to the CDC and ACOG in the 10th Edition of the Australian Immunisation Handbook.
Chapter amended in response to commentATAGI's decision  at this stage is that there is insufficient evidence to recommend routine vaccination of pregnant women with dTpa. However, text has been amended to improve clarity that vaccin-
ation during pregnancy is anacceptable alternative option, and also to provide option of shorter interval for dTpa in context of pregnancy (in 3.3 and pertussis chapter).
313.3 Groups with special vaccination requirements7548-60References

1. Centers for Disease Control and Prevention (CDC). General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morbidity and Mortality Weekly Report 2011; 60 (No.2): 26.

2. Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged <12 months   Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morbidity and Mortality Weekly Report 2011; 60 (No. 41): 1424-6.
Chapter amended in response to commentATAGI's decision  at this stage is that there is insufficient evidence to recommend routine vaccination of pregnant women with dTpa. However, text has been amended to improve clarity that vaccin-
ation during pregnancy is anacceptable alternative option, and also to provide option of shorter interval for dTpa in context of pregnancy (in 3.3 and pertussis chapter).
313.3 Groups with special vaccination requirements7548-60References (continued)

3. American College of Obstetricians and Gynecologists (ACOG). Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination. ACOG Committee Opinion No. 521. Obstet Gynecol 2012; 119: 690-1.

4. Centers for Disease Control and Prevention (CDC). Prevention of Pertussis, Tetanus, and Diphtheria Among Pregnant and Postpartum Women and Their Infants. Recommendations of The Advisory Committee on Immunization Practices (ACIP). MMWR 2008; 57 (No. RR-4).

5. World Health Organization (WHO). Pertussis vaccines: WHO position paper. Weekly epidemiological record 2010; No. 40, 85: 385-400.
Chapter amended in response to commentRefer comment no 45.
313.3 Groups with special vaccination requirements7548-60Background

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) Women s Health Committee (WHC) recently considered a request from a RANZCOG Fellow, for the College to recommend pertussis vaccination in pregnant women, in line with the March 2012 Centers for Disease Control and Prevention (CDC)  Guidelines for Vaccinating Pregnant Women  and the American College of Obstetricians and Gynecologists (ACOG) Committee Opinion 521  Update on Immunization and Pregnancy.

However, it was noted during this discussion that the Australian Technical Advisory Group on Immunisation (ATAGI) is currently undertaking a public consultation phase of the draft of the 10th Edition of the Australian Immunisation Handbook. The WHC thought it would be timely to put forward a submission towards addressing this.

In essence, the CDC and the ACOG recommend that pertussis vaccination be given to women during pregnancy in the second and third trimesters.
Chapter amended in response to commentRefer comment no 45.
313.3 Groups with special vaccination requirements7548-60The CDC states:

Risk to a developing fetus from vaccination of the mother during pregnancy is theoretical. No evidence exists of risk to the fetus from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids. Live vaccines administered to a pregnant woman pose a theoretical risk to the fetus; therefore, live, attenuated virus and live bacterial vaccines generally are contraindicated during pregnancy. Benefits of vaccinating pregnant women usually outweigh potential risks when the likelihood of disease exposure is high, when infection would pose a risk to the mother or fetus, and when the vaccine is unlikely to cause harm.  1
Chapter amended in response to commentRefer comment no 45.
313.3 Groups with special vaccination requirements7548-60The CDC states:

Risk to a developing fetus from vaccination of the mother during pregnancy is theoretical. No evidence exists of risk to the fetus from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids. Live vaccines administered to a pregnant woman pose a theoretical risk to the fetus; therefore, live, attenuated virus and live bacterial vaccines generally are contraindicated during pregnancy. Benefits of vaccinating pregnant women usually outweigh potential risks when the likelihood of disease exposure is high, when infection would pose a risk to the mother or fetus, and when the vaccine is unlikely to cause harm.  1
Chapter amended in response to commentRefer comment no 45.
313.3 Groups with special vaccination requirements7548-60In addition, the CDC states:

Routine Booster: If a tetanus and diphtheria booster vaccination is indicated during pregnancy for a woman who has previously not received tetanus, diphtheria and pertussis vaccines, Tdap (i.e., more than 10 years since previous tetanus and diphtheria toxoids vaccines, Td), then health care providers should administer Tdap during pregnancy, preferably during the third or late second trimester (after 20 weeks  gestation).  2
Chapter amended in response to commentRefer comment no 45.
313.3 Groups with special vaccination requirements7548-60The ACOG states:

Women s health care providers should implement a Tdap vaccination program for pregnant women who previously have not received Tdap. Health care providers should administer Tdap during pregnancy, preferably during the third trimester or late second trimester (i.e. after 20 weeks of gestation).  3
Chapter amended in response to commentRefer comment no 45.
483.3 Groups with special vaccination requirements74Not applicable Sex workers are a distinct group who share experiences of stigma and discrimination and are recognised as a ‘priority population’ by the Australian Government’s National HIV, STI  and Hepatitis B Strategies. Sex workers also include other ‘priority population’ communities who are Culturally and Linguistically Diverse (CALD), Men who have Sex with Men (MSM), Aboriginal and Torres Strait Islander (ATSI), Sex and/or Gender Diverse (SGD) and People who Inject Drugs (PWIDs). Scarlet Alliance recommends that sex workers be included as a 'Group with Special Vaccination Requirements', alongside 'MSM' and 'PWIDs'. We recommend inserting a new section 3.3.12 to list sex workers as a specific group with special vaccination requirements. This is necessary to promote national consistency in groups and communities eligible for funded vaccination, to increase the uptake of vaccinations among priority populations. Chapter amended in response to commentNot applicable
483.3 Groups with special vaccination requirements74Not applicable Sex workers are a distinct group who share experiences of stigma and discrimination and are recognised as a ‘priority population’ by the Australian Government’s National HIV, STI  and Hepatitis B Strategies. Sex workers also include other ‘priority population’ communities who are Culturally and Linguistically Diverse (CALD), Men who have Sex with Men (MSM), Aboriginal and Torres Strait Islander (ATSI), Sex and/or Gender Diverse (SGD) and People who Inject Drugs (PWIDs). Scarlet Alliance recommends that sex workers be included as a 'Group with Special Vaccination Requirements', alongside 'MSM' and 'PWIDs'. We recommend inserting a new section 3.3.12 to list sex workers as a specific group with special vaccination requirements. This is necessary to promote national consistency in groups and communities eligible for funded vaccination, to increase the uptake of vaccinations among priority populations. Chapter amended in response to commentNot applicable
483.3 Groups with special vaccination requirements93-95Table 3.3.6In the current draft, 'sex industry workers' are listed under the heading 'Vaccination of those at occupational risk'. Instead of being listed under 'Occupation',we are included under the heading 'Others exposed to human tissue, blood, body fluids or sewage'. Recognising sex work as work reflects the central premise that sex work is a legitimate form of occupation, deserving of the same rights and protections (occupational health and safety, industrial rights and human rights) as other professions. Recognising sex work as a legitimate occupation in consistent with the worldwide best-practice approach of decriminalisation, recommended by UNAIDS, the UN Population Fund (UNFPA) and UN Secretary General Ban Ki Moon. However, as stated in the comments above and below, it is crucial that vaccines are consistently available to sex workers and that policies are clear and consistent across Australian jurisdictions that sex workers are a priority population. Listing sex workers as part of the 'occupational risk' category has meant that sex workers have been forgotten in state and territory policies. There is significant inconsistencies acoss jurisdictions on policies for sex worker access to funded vaccinations. These inconsistencies translate into increased barriers to sex workers’ awareness of, access to and completion of vaccines. We believe that sex workers should instead be listed as a new category under 3.3.12 as a specific group with special vaccination requirements.Chapter amended in response to commentNot applicable
483.3 Groups with special vaccination requirements93-95Table 3.3.6In the current draft, 'sex industry workers' are listed under the heading 'Vaccination of those at occupational risk'. Instead of being listed under 'Occupation',we are included under the heading 'Others exposed to human tissue, blood, body fluids or sewage'. Recognising sex work as work reflects the central premise that sex work is a legitimate form of occupation, deserving of the same rights and protections (occupational health and safety, industrial rights and human rights) as other professions. Recognising sex work as a legitimate occupation in consistent with the worldwide best-practice approach of decriminalisation, recommended by UNAIDS, the UN Population Fund (UNFPA) and UN Secretary General Ban Ki Moon. However, as stated in the comments above and below, it is crucial that vaccines are consistently available to sex workers and that policies are clear and consistent across Australian jurisdictions that sex workers are a priority population. Listing sex workers as part of the 'occupational risk' category has meant that sex workers have been forgotten in state and territory policies. There is significant inconsistencies acoss jurisdictions on policies for sex worker access to funded vaccinations. These inconsistencies translate into increased barriers to sex workers’ awareness of, access to and completion of vaccines. We believe that sex workers should instead be listed as a new category under 3.3.12 as a specific group with special vaccination requirements.Chapter amended in response to commentNot applicable
483.3 Groups with special vaccination requirements96Not applicable We propose a new heading under 3.3.12 to list sex workers as a specific group with special vaccination requirements. Research in Australia from the Law and Sex worker Health Study, Kirby Institute and Roberta Perkins consistently shows that sex workers have high rates of condom use, high rates of testing, and low rates of STIs/HIV. The National HIV Strategy speaks about ‘maintaining’ these low rates through continued investment in programs for priority populations. However sex workers continue to face barriers to accessing vaccinations - Current state and territory hepatitis B funding programs are ad hoc in their recognition of sex workers as an eligible group for funded vaccinations. Although voluntary testing remains the optimal model to HIV/STI testing in Australia’s National Strategies, sex workers face mandatory testing in some jurisdictions. Sex workers face specific issues relating to cost of vaccination and the needs of people in regional/remote areas. Regulatory frameworks around sex work, including criminalisation and licensing, act as barriers to sex workers accessing vaccinations. Sex workers surveyed in Queensland and Victora, where licensing jurisdictions were in place, consistently showed lower levels of knowledge and access than in NSW, where sex work is decriminalised. Criminalisation of sex workers with an STI means that sex workers who suspect they may have contracted STIs may be reluctant undergo testing for fear of discrimination from their workplaces. Sex workers report stigma and discrimination in accessing health or service providers, including reluctance to engage with the health system due to past negative experiences, and fears about disclosing sex worker status for risk of prosecution. In a Scarlet Alliance survey, trauma from discrimination in a sexual health clinic was given as a reason for one sex worker not completing a vaccination course. There remain inconsistent policies across jurisdictions on the availability of free or subsidised vaccines for sex workers. It is crucial that sex workers be listed as a specific group with special vaccination requirements (not just 'those at occupational risk'). Chapter amended in response to commentNot applicable
224.1 Cholera10637-47Suggest changing 'A recent randomised controlled trial of this vaccine in India reported a protective efficacy of 67 per cent' to the following -  'A recent randomised controlled trial of this vaccine in India reported a protective efficacy of 67 per cent against V.cholerae 01'. Note that in the limitations of the study conducted by Sur et al. the authors state that V.cholerae 0139 was not detected in the surveillance, precluding an assessment of vaccine protection against this group. Suggest separating data for Dukoral, (37-41 and 45-47)  from data for Shanchol (42-44) to avoid confusion.Chapter amended in response to commentNot applicable
224.1 Cholera10716-21Note Dukoral Approved Product Information age recommendations - 'Children from 2 to 6 years of age should receive 3 doses' and 'Basic immunisation comprises 2 doses of vaccine for adults and children over the age of 6.' Chapter amended in response to commentNot applicable
224.1 Cholera10629Change 'Sanofi Pasteur Pty Ltd' to 'CSL Limited and Crucell Sweden AB'. Note that transfer of sponsorship to CSL Limited occurred in December 2011.Chapter amended in response to commentNot applicable
224.1 Cholera10736-37Note references regarding travellers at increased risk of diarrhoeal disease. Refs. Zuckerman et al. Lancet Inf Dis 2007, 7, 521-30, Jelinek et al. Exp Rev Vacc 2008, 7(5), 561-67 and Weinke et al, 2008 Travel Men Inf Dis 6
pp362-367.
Chapter amended in response to commentNot applicable
224.1 Cholera10637-41Suggest also the inclusion of 'Clinical results have revealed a protective efficacy against cholera of 85 percent for the first six months in all age categories although efficacy had fallen to 52 percent at the end of the second year ......' as per the Dukoral Product Information (Bangladesh Trial)  For Mozambique trial, suggest to also present results for per protocol analysis (two doses) refer to Table 2 Lucas et al 2005 NEJM 352(8), p757-767. Chapter amended in response to commentNot applicable
224.1 Cholera10826Note variation from Dukoral Product Information Dosage and Administration Booster recommendations.Chapter amended in response to commentNot applicable
304.1 Cholera10629-34Acknowledges Dukoral as supplied by Sanofi Pasteur. This product is now supplied by CSL Biotherapies.Chapter amended in response to commentNot applicable
524.2 Diphtheria11329-32It appears from the Pertussis chapter that dTpa is given at 10 yearly intervals for those with risk factors. You may need to add to this last line (with the exception of dTpa).Chapter amended in response to commentNot applicable
374.2 Diphtheria11041See previous comment about reference to these vaccines now being used in children less than 10 years of age. No action required Included in the What's New section
374.2 Diphtheria11313-28There is inconsistent and confusing advice in the text about the age ranges  for specific diphtheria containing vaccines.Chapter amended in response to commentNot applicable
304.2 Diphtheria11041-30Would it be possible to include Sanofi Pasteur's products  TRIPACEL and PEDIACEL?Chapter amended in response to commentNot applicable
114.2 Diphtheria11021-23For clarity, the following text is suggested (to align with information listed in CDI)- Almost all recent cases in the United Kingdom and the United States have been associated with imported infections. In Australia there have been three imported cases, one occurring in 2001 and more recently two occurring in 2011 of which one involved a cluster of 3 cases, including 1 death. Chapter amended in response to commentNot applicable
114.2 Diphtheria1126GSK note the difference between the Handbook recommendation (11-13 years) and the NIP schedule (10 to 17 years).  Should this difference be noted in the Handbook?Chapter amended in response to commentNot applicable
114.2 Diphtheria11238Please note that additional contraindications are contained in the diphtheria-containing vaccines Product Information leaflets.Chapter amended in response to commentNot applicable
114.2 Diphtheria11335-36Please note that Boostrix and Boostrix IPV Product Information leaflets also recommend a 5 year lapse since last tetanus vaccination.  Chapter amended in response to commentNot applicable
524.3 Haemophilus influenzae
type b
117102 weeks before a planned splenectomy or following an emergency splenectomy.Chapter amended in response to commentNot applicable 
284.3 Haemophilus influenzae
type b
11621No mention that Hiberix requires reconstitution, but is highlighted for Menitorix and Infanrix hexaChapter amended in response to commentNot applicable 
224.3 Haemophilus influenzae
type b
1163Please include Liquid PedvaxHIB in all relevant sections of this chapter. Liquid PedvaxHIB is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no Liquid PedvaxHIB used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL has recently submitted a response for Haemophilus influenzae type B vaccine (12 month cohort) Request for Tender.Chapter amended in response to commentNot applicable 
304.3 Haemophilus influenzae
type b
1163Would it be possible to include Sanofi Pasteur's product Act-Hib within the list of monovalent vaccines? Chapter amended in response to commentNot applicable 
114.3 Haemophilus influenzae
type b
11621Please note that Hiberix also requires reconstitution.  By omission it could be taken that Hiberix doesn't require reconstitution.  For consistency, please consider including text on the reconstitution of Hiberix - Hiberix must be reconstituted by adding the entire contents of the diluent container to the vial containing the Hib pellet.  The reconstituted solution must be shaken well before use, and must not be injected prior to complete dissolution of the Hib pellet.  Reconstituted vaccine should be used promptly or kept in a refrigerator and be discarded if not used within 24 hours.Chapter amended in response to commentNot applicable 
114.3 Haemophilus influenzae
type b
11624-25Please consider including information on the stability of the vaccine after reconstituted - "Use as soon as practicable after reconstitution.  If storage is necessary, hold at 2ºC-8ºC for not more than 24 hours."Chapter amended in response to commentNot applicable 
114.3 Haemophilus influenzae
type b
11621Please note that Hiberix also requires reconstitution.  By omission it could be taken that Hiberix doesn't require reconstitution.  For consistency, please consider including text on the reconstitution of Hiberix - Hiberix must be reconstituted by adding the entire contents of the diluent container to the vial containing the Hib pellet.  The reconstituted solution must be shaken well before use, and must not be injected prior to complete dissolution of the Hib pellet.  Reconstituted vaccine should be used promptly or kept in a refrigerator and be discarded if not used within 24 hours.Chapter amended in response to comment  Duplicate comment -see #5Not applicable 
114.3 Haemophilus influenzae
type b
11624-25Please consider including information on the stability of the vaccine after reconstituted - "Use as soon as practicable after reconstitution.  If storage is necessary, hold at 2ºC-8ºC for not more than 24 hours."Chapter amended in response to comment  Duplicate comment - see #6Not applicable 
114.3 Haemophilus influenzae
type b
11626-27Please consider adding information on the stability of the vaccine after reconstitution - "After reconstitution, the vaccine should be injected immediately.  However, the vaccine may be kept for up to 8 hours at room temperature."Chapter amended in response to commentNot applicable 
444.4
Hepatitis A
12019In addition to comment about HAV not causing chronic liver disease, would also be helpful to note also that there is no chronic carrier state in HAV.Chapter amended in response to commentNot applicable
444.4
Hepatitis A
12230This sentence deals with screening of certain groups for evidence of immunity to hepatitis A prior to vaccination.  The current 9th edition includes the words: "To avoid unnecessary vaccination..." at the start of the sentence and these words have been removed from the draft edition.  I think they should be put back in.  While it is implied that the sentence relates to vaccination, taken on its own it looks like general screening should be undertaken for these groups.Chapter amended in response to commentNot applicable
74.4
Hepatitis A
12314Remove "intellectual" and incorporate carers of "all' disabilities (as per comment above).Chapter amended in response to commentAmended in response to comment, but please note not all disabilities appropriate in this context (changed to developmental)
74.4
Hepatitis A
12320People with all types of disabilities would have the same risk factors (as per comments above).Chapter amended in response to commentNot applicable
154.4
Hepatitis A
12313The term 'early childhood education and care' is more commonly used to describe childcare pre-school services, and incorporates long day-care, family day-care, pre-Prep and kindergarten. The same comment applies to the use of 'childcare and pre-school' on line 13 of page 158.Chapter amended in response to commentNot applicable
224.4
Hepatitis A
12055Suggest changing '0.225mg aluminium hydroxide' to 'approximately 0.225mg of aluminium provided as aluminium hydroxide' as per the Vaqta Approved Product Information.Chapter amended in response to commentNot applicable
224.4
Hepatitis A
1213Suggest changing '0.45mg aluminium hydroxide' to '0.45mg of aluminium provided as aluminium hydroxide' as per the Vaqta Approved Product Information.Chapter amended in response to commentNot applicable
224.4
Hepatitis A
1221The statement 'equivalent vaccines of the different manufacturers are interchangeable' may cause confusion given the differing age indications of the vaccines and also the evidence-based interchangeability of the booster dose (using Vaqta) following the initial dose of other inactivated hepatitis A vaccines (Refer to Approved Product Information).Chapter amended in response to commentNot applicable
224.4
Hepatitis A
1231For further clarification regarding dosing interval, suggest referring to Table 4.4.1.Chapter amended in response to commentNot applicable
224.4
Hepatitis A
12329Should separate monovalent Hepatitis A and B vaccines also be included in cases where the combination vaccines are not available.Chapter amended in response to commentNot applicable
474.4
Hepatitis A
1225We have queries about interchangeability of monvalent hep A vaccines and Twinrix - it would be good to add to this section that these are NOT interchangeable.Chapter amended in response to commentNot applicable
534.5
Hepatitis B
13443... documented history of a primary age appropriate course of hepatitis B vaccine...Chapter amended in response to commentNot applicable
284.5
Hepatitis B
129524 weeks of age is 168 days, not 164 (24 x 7 = 168).Chapter amended in response to commentBased on trial data. Amended text for clarification.
334.5
Hepatitis B
12741Newly diagnosed cases of HBV infection do not mostly occur as a result of horizontal transmission (sexual and injecting drug use routes), this applies only to newly acquired infection. Risk factors for newly diagnosed hepatitis B (the 31 cases per 100,000 referred to) are not reported in the Annual Surveillance Report cited- the major risk factor for newly diagnosed hepatitis B is birth in a high HBV prevalence country (reference 10, OSullivan 2004 ANZJPH).Chapter amended in response to commentNot applicable
334.5
Hepatitis B
12741Newly diagnosed cases of HBV infection do not mostly occur as a result of horizontal transmission (sexual and injecting drug use routes), this applies only to newly acquired infection. Risk factors for newly diagnosed hepatitis B (the 31 cases per 100,000 referred to) are not reported in the Annual Surveillance Report cited- the major risk factor for newly diagnosed hepatitis B is birth in a high HBV prevalence country (reference 10, OSullivan 2004 ANZJPH).Chapter amended in response to comment - Duplicate comment - #3Not applicable
434.5
Hepatitis B
12744Suggest add at the end of this paragraph: "A significant proportion of new infections go undetected, as they are asymptomatic."
Rationale: This is consistent with the statement line 10 that only 30-50% of adults have symptomatic acute hepatitis; it reminds readers that the true incidence may be twice that quoted in line 40
Chapter amended in response to comment Not applicable
434.5
Hepatitis B
12747Suggest add after 2nd dot point, in brackets: "(such as tattooing and body piercing)"
Rationale: This is consistent with the other dot points that give examples, highlights these activities as known risks, and is consistent with page 134 line 7 that recommends that workers in these fields be immunised.
Chapter amended in response to commentNot applicable
504.5
Hepatitis B
12753Reducing hepatitis B infection in Australia not only relates to vaccination, but also other interventions such as securing the blood supply. The wording of this sentence should be amended to "the strategy for the prevention of new/acute hepatitis B infection in Australia..." Chapter amended in response to commentNot applicable
334.5
Hepatitis B
12740-44This section on hepatitis B epidemiology could be improved by more clearly differentiating acute and chronic infection and their incidence rates, trends over time and risk factors (see response 2). Chapter amended in response to commentNot applicable
334.5
Hepatitis B
12740-44This section on hepatitis B epidemiology could be improved by more clearly differentiating acute and chronic infection and their incidence rates, trends over time and risk factors (see response 2). Chapter amended in response to comment - Duplicate comment - see #8Not applicable
504.5
Hepatitis B
12740-52While recognising that the vaccination reduces new hepatitis B infections, the handbook should recognise that the greatest burden of hepatitis B infection on the Australian health care system relates to chronic hepatitis B infection, rather than the acute infection of adults.Chapter amended in response to commentNot applicable
434.5
Hepatitis B
12845Suggest this reads: "Where infants have not received a birth dose (i.e. within the first week of life), no catchup of that dose is required. Such infants require..." 
Rationale: Reinforces that the birth dose can be given up to 7 days old (as per page 132), and clarifies when one would or would not give that dose. Splitting this sentence, and removing the word "still", improves clarity.
Chapter amended in response to commentNot applicable
434.5
Hepatitis B
12851Suggest add at end of this para: "They can be considered fully vaccinated."
Rationale: Without this statement, the implications of the previous statement about the overseas schedule are not clear. It is also consistent with statement page 132 lines 11-12.
Chapter amended in response to commentNot applicable
294.5
Hepatitis B
12915-17This sentence regarding the minimum time period between hepatitis B doses for a non accelerated adult vaccine course appears to be in conflict with the table on page 26 (section 2). Chapter amended in response to commentNot applicable
434.5
Hepatitis B
13112The footnote stating an accelerated schedule is not suitable for those needing prompt protection does not sound logical, so may need more explanation (i.e. fact that most will be immune after 2nd dose, either way).Chapter amended in response to commentNot applicable
444.5
Hepatitis B
13121-22I think it would be helpful to have a brief note to expand on the naming convention, to the effect that the birth dose is not usually numbered and doses 1, 2 and 3 are given at months 2, 4 and 6.  Confusion over the naming convention does occur, with some people interpreting the birth dose as dose 1.Chapter amended in response to commentNot applicable
334.5
Hepatitis B
13258Aboriginal and Torres Strait Islander adults should be one of the groups recommended for hepatitis B vaccination, given their previously stated increased risk (page 127, line 30).Chapter amended in response to commentNot applicable
334.5
Hepatitis B
13258Aboriginal and Torres Strait Islander adults should be one of the groups recommended for hepatitis B vaccination, given their previously stated increased risk (page 127, line 30).Chapter amended in response to comment.  Duplicate comment - see #16Not applicable
434.5
Hepatitis B
13259-60I think the asterisks on the following page 133 would be better placed after the word "vaccinated" in each relevant paragraph.
Rationale: An asterisk against certain at-risk group names seems inappropriate in some way.
Chapter amended in response to commentNot applicable
504.5
Hepatitis B
13328In terms of consistency within the document and other Australian government policy, the title of this section should be "People who inject drugs".  Chapter amended in response to commentNot applicable
504.5
Hepatitis B
13351Any inmate, rather than only those of long term correctional facilities, is at risk of hepatitis B infection as a result of inherent factors related to incarceration.  Many of the populations at greater risk of hepatitis B infection are also at greater risk of acute hepatitis B infection.Chapter amended in response to commentNot applicable
74.5
Hepatitis B
13340-42Same as comments above, should be all types of disabilities, not just intellectual.Chapter amended in response to commentNot applicable
74.5
Hepatitis B
1346Same as comments above, should be all types of disabilities, not just intellectual.Chapter amended in response to comment -Duplicate comment - see #21Not applicable
434.5
Hepatitis B
13433Suggest sentence reads: "possibility of chronic HBV infection should be investigated by serological testing for HBsAg."
Rationale: Clarifies need to test for asymptomatic chronic disease, and the correct test to do.
Chapter amended in response to commentNot applicable
434.5
Hepatitis B
13448Suggest this reads: "Persons at significant occupational risk who have been tested and found to be a non-responder (and in whom chronic HBV infection has been excluded)..."
Rationale: Clearer, and see previous comment.
Chapter amended in response to commentNot applicable
434.5
Hepatitis B
13450Suggest replace "give" with "should have", and "re-test" with "be re-tested".
Rationale: Passive voice more appropriate than active. 
Chapter amended in response to commentNot applicable
434.5
Hepatitis B
13450Suggest standardise suggested number of doses in this scenario: this line reads 2 for health workers, whereas line 46 refers to 3 further doses if not responding.Chapter amended in response to commentNot applicable
434.5
Hepatitis B
13458I think there needs to be brief advice given about the scenario of isolated anti-HBc positivity, as this is a pattern increasingly being seen by GPs and migrant health services (we see it frequently in African refugees in particular). The most frequent cause is likely to be just unmeasurable anti-HBs. Occult HBV is also a possibility. The National Hepatitis B Testing Policy (under development) will recommend in this scenario Consider HBV DNA testing (to check for occult HBV), but also will say Consider repeat serology and vaccination. My view is the Handbook should say: Give single dose of vaccine and then repeat serology. This has the dual benefit of potentially ruling out an initial false positive cAb, and/or may in many cases demonstrate return of adequate sAb (undetectable on first test). This may be reflected in the national testing policy as well.Chapter amendedin response to commentNot applicable
434.5
Hepatitis B
13444-45Suggest this reads: "Persons in whom chronic HBV infection has been excluded.."
Rationale: Emphasises that action is needed to check for chronic disease.
Chapter amended in response to commentNot applicable
444.5
Hepatitis B
13452-54The 9th edition of the Handbook (p. 160) had more detail about intradermal administration of vaccine, i.e. at fortnightly intervals up to 4 doses.  I have previously found this information and would like the level of detail to remain in the new edition, if possible?No action requiredEvidence for this method is limited.
434.5
Hepatitis B
13519Suggest this reads:  "expected in some neonates"
Rationale: sentence statesthat fever occurs in under 4%.
Chapter amended in response to commentNot applicable
434.5
Hepatitis B
13535Suggest add: "where feasible" at end of sentence.
Rationale: it's not always possible to know who the source is.
Chapter amended in response to commentNot applicable
434.5
Hepatitis B
1363Suggest this reads: " ; however administration..."
Rationale: Emphasises and clarifies this point which follows the statement about possibly giving up to 14 days after contact.
Chapter amended in response to commentNot applicable
394.5
Hepatitis B
1293Does not add up correctly, if a person has a 0, 1, 2 month course the minimum is 3 months, not 4 months. Are we reading this correctly? Otherwise it is confusing and contradicting the previous 2 lines.Chapter amended in response to commentNot applicable
394.5
Hepatitis B
12849Will ACIR accept a overseas client with a birth, 1month, 6 month schedule? No action requiredInformation provided in handbook
334.5
Hepatitis B
12741Newly diagnosed cases of HBV do not mostly occur as a result of horizontal transmission, this applies only to newly acquired HBV. Risk factors for newly diagnosed HBV (the 31 cases per 100,000) are not reported in the Annual Surveillance Report cited, the major risk factor for newly diagnosed HBV is birth in a high HBV prevalence country (ref 10, OSullivan 2004). Chapter amended in response to comment -Duplicate comment - see #3Not applicable
334.5
Hepatitis B
12740-44This section on hepatitis B epidemiology could be improved by more clearly differentiating acute and chronic infection and their incidence rates, trends over time and risk factors (see response 2). Chapter amended in response to comment -Duplicate comment - see #8Not applicable
334.5
Hepatitis B
13258Aboriginal and Torres Strait Islander adults should be one of the groups recommended for hepatitis B vaccination, given their previously stated increased risk (page 127, line 30).Chapter amended in response to comment -Duplicate comment - see #16Not applicable
384.5
Hepatitis B
12747To be consistent with line number 34, the wording of line number 47 (needle-stick injury and other types of parenteral inoculation) should read 'needlestick injury and other types of parenteral inoculation or mucosal contact'. Chapter amended in response to commentNot applicable
394.5
Hepatitis B
13456'They should also be informed about the need for HBIG within 72 hours of parenteral exposure to HBV' should read, 'They should also be informed about the need for HBIG within 72 hours of parenteral or mucosal exposure to HBV'. Chapter amended in response to commentNot applicable
404.5
Hepatitis B
13442It may be useful to refer to studies about the use of the combined hepatitis A/hepatitis B vaccine in non-responders.No action requiredLimited evidence to support this recommend-
ation
64.5
Hepatitis B
12753The strategy for prevention of hepatitis B in Queensland actually commenced in 1984 - Queensland vaccinated babies from high risk hepatitis B countries and babies born to HBsAg positive mothers.Chapter amended in response to commentNot applicable
94.5
Hepatitis B
12935Delete the sentence referring to older adolescents as again Correctional facilities et al will be tempted to give two doses.Chapter amended in response to commentNot applicable
94.5
Hepatitis B
1319Heading Accelerated Schedule'
-'0-1-2 months interval  schedule - where did this come from as it is not referenced anywhere else in the chapter? 
Chapter amended in response to commentNot applicable
94.5
Hepatitis B
13112Imminent risk of exposure" is defined in line 7 as "those "intending to travel ...before departure". Line 12 under the table then provides another reason (is it what we would recommend?) however, again, will permit high risk inmates and STD/methadone clinic attendees to receive an accelerated schedule and these people, almost without fail, will not receive the 12 month booster dose. Chapter amended in response to commentNot applicable
94.5
Hepatitis B
13266 weeks of age' - delete 'if necessary for programmatic reasons and for consistency - the 6 week recommendation needs to be added to line 39 on previous page (not buried over the page).  Chapter amended in response to commentNot applicable
94.5
Hepatitis B
13354Referring to inmates - why screen them? - in practice this is not practical and is a hangover maybe from the 9th edition - I would suggest we recommend vaccination as we do for injecting drug users in line 29 same page.No action requiredTesting is required to provide opportunity for treatment for chronic infection (as well as vaccination if non-immune). However, to address this comment amendments to improve clarity have been made to the section on testing.
Top of Page

10th Edition Australian Immunisation Handbook – Public Consultation Responses continued.

Submission No:  1-54Part No Page NoLine NoCommentsProposed ActionRationale
94.5
Hepatitis B
13613The reference to the PI stating that Infanrix Hexa is indicated from 6 weeks of age needs to be deleted as it is no longer a variation.Chapter amended in response to commentNot applicable
94.5
Hepatitis B
12845Relating to birth dose - add 'within 7 days of birth'.Chapter amended in response to commentNot applicable
94.5
Hepatitis B
12929Delete lines 29 - 31 as it relates to adults (under the heading "Alternative 2-dose schedules for adolescents") and will lead to confusion and Correctional facilities et al believing they can off two doses. Chapter amended in response to commentNot applicable
164.5
Hepatitis B
13258As discussed relevant to section 3.1, there is substantial evidence that Aboriginal and Torres Strait Islander adults have 3-5 times the incidence of acute HBV infection when compared to non-Indigenous individuals. Therefore (following serologic testing to determine baseline status) it should be recommended that all Indigenous Australians who are susceptible be offered vaccination against HBV.Chapter amended in response to commentNot applicable
164.5
Hepatitis B
13258Similarly, people born in intermediate-high HBV prevalence countries who remain susceptible to HBV are at higher risk of incident HBV infection than other members of the community. Adults born overseas in HBV endemic areas should also be recommended for HBV vaccination, again following serologic testing to ascertain for the presence of existing immunity or for established chronic hepatitis B infection. Chapter amended in response to commentNot applicable
514.5
Hepatitis B
12636-39Routes of transmission are described.  No citations are offered to substantiate the information about hepatitis B transmission and saliva.  Likewise, transmission risk from razors and toothbrushes is described as negligible, without citation.  It is important to be very clear about the risk of transmission from saliva, and the very specific context that the evidence has demonstrated that may occur.Chapter amended in response to commentNot applicable
514.5
Hepatitis B
12740-44This section on hepatitis B epidemiology could be improved by more clearly differentiating acute and chronic infection and their incidence rates, trends over time and risk factors. Chapter amended in response to comment -Duplicate comment - see #8Not applicable
514.5
Hepatitis B
12740-52While recognising that vaccination reduces new hepatitis B infections, the handbook should recognise that the greatest burden of hepatitis B infection on the Australian health care system relates to chronic hepatitis B infection and the resulting consequences (such as liver cancer and cirrhosis), rather than the acute infection of adults.Chapter amended in response to comment -Duplicate comment - see #10Not applicable
514.5
Hepatitis B
12741Newly diagnosed cases of HBV do not mostly occur as a result of horizontal transmission, this applies only to newly acquired HBV. Risk factors for newly diagnosed HBV (the 31 cases per 100,000) are not reported in the Annual Surveillance Report cited, the major risk factor for newly diagnosed HBV is birth in a high HBV prevalence country (ref 10, OSullivan 2004).Chapter amended in response to comment -Duplicate comment - see #3Not applicable
514.5
Hepatitis B
12753Reducing hepatitis B infection in Australia not only relates to vaccination, but also other interventions such as securing the blood supply. The wording of this sentence should also be amended to "the strategy for the prevention of new/acute hepatitis B infection in Australia..."Chapter amended in response to comment -Duplicate comment - see #7Not applicable
514.5
Hepatitis B
13135The hepatitis B section should have a section. For persons with natural immunity similar to the section under the Hepatitis A recommendations (Page 122 line 9). Screening should be recommended for those who were born or spent their early childhood in an endemic area; Aboriginal and Torres Strait Islander people; and those with an unexplained previous episode of hepatitis or jaundice.Chapter amended in response to commentNot applicable
514.5
Hepatitis B
13258People born in endemic areas should be included as a recommended group for hepatitis B vaccination following serological confirmation of susceptibility. Chronic hepatitis B infection is most often seen as a result of vertical transmission in countries where hepatitis B is endemic. The majority of chronic hepatitis B cases in Australia are seen in culturally and linguistically diverse (CALD) communities from countries where hepatitis B is endemic. Up to 1/3 of chronic hepatitis B cases in Australia are undiagnosed, which can lead to household and sexual transmission of hepatitis B without the opportunity of household or sexual contacts being offered vaccination.  (a list of countries with high endemicity should be included here).Chapter amended in response to commentNot applicable
514.5
Hepatitis B
13258Aboriginal and Torres Strait Islander adults should be one of the groups recommended for hepatitis B vaccination, given their previously stated increased risk (page 127, line 30).Chapter amended in response to comment -Duplicate comment - see #16Not applicable
514.5
Hepatitis B
1331Consider including household or other close contact.Chapter amended in response to commentNot applicable
514.5
Hepatitis B
13328In terms of consistency within the document and other Australian government policy, the title of this section should be "People who inject drugs".  Chapter amended in response to comment -Duplicate comment - see #19Not applicable
514.5
Hepatitis B
13351Any inmate, rather than only those of long term correctional facilities, is at risk of hepatitis B infection as a result of inherent factors related to incarceration.  Chapter amended in response to comment -Duplicate comment - see #20Not applicable
454.5
Hepatitis B
12744Add a statement such as: The largest burden of chronic hepatitis B in Australia lies within migrant communities, largely due to transmission in early life, and with many individuals unaware they are infected.Chapter amended in response to commentNot applicable
224.5
Hepatitis B
12725Note following reference regarding the risk of Hepatitis B in diabetics -
Reilly et al. Increased Risk of Acute Hepatitis B among Adults with Diagnosed Diabetes Mellitus. Journal of Diabetes Science and Technology July 2012, 6(4).
Chapter amended in response to commentNot applicable
224.5
Hepatitis B
1301Suggest separating the details of each Engerix and HB VAX II (paediatric) into individual rows as there may be potential for confusion if combined. Note references on accelerated and alternate schedules for HBVAXII - Jilg et al 1989 JID 160, pp 766-769 and Seto et al 2002 JPID 21 pp793-794 as cited in Venters et al 2004 Exp Rev Vaccines 3 Issue 2 pp119-129.Chapter amended in response to commentNot applicable
224.5
Hepatitis B
13258Note the addition of unvaccinated adults aged 19 to 59 with diabetes mellitus (and unvaccinated adults aged greater than or equal to 60 years with diabetes mellitus at the discretion of the physician) in the recent ACIP recommendations. ACIP. MMWR 2011, 60, 1709 to 1711.No action requiredChapter was reviewed and one study noted, but evidence was insufficient to support recommending the vaccination of diabetics in Australia.
474.5
Hepatitis B
12840Providers are often confused about the different doses between the GSK and CSL brands of Hep B.  The description on page 122 line 5 of the Hep A sections explains this really nicely about Hep A vaccine - it would be good to reapeat this for Hep B - but put it under the heading - Interchangeability of hepatitis B vaccines on page 131 line 29.Chapter amended in response to commentNot applicable
474.5
Hepatitis B
13129Providers are often confused about the different doses between the GSK and CSL brands of Hep B.  The description on page 122 line 5 of the Hep A sections explains this really nicely about Hep A vaccine - it would be good to reapeat this for Hep B - but put it under the heading - Interchangeability of hepatitis B vaccines on page 131 line 29.Chapter amended in response to comment -Duplicate comment - see #67Not applicable
474.5
Hepatitis B
13231-33This section does not have information on what to do if the antibody levels are inadequate.Chapter amended in response to commentNot applicable
474.5
Hepatitis B
13443As the person on the other end of the phone at the public health authority I would like the handbook to guide me as to what advice to give in this scenario.No action requiredInformation provided in handbook
164.5
Hepatitis B
13258As discussed relevant to section 3.1, there is substantial evidence that Aboriginal and Torres Strait Islander adults have 3-5 times the incidence of acute HBV infection when compared to non-Indigenous individuals. Therefore (following serologic testing to determine baseline status) it should be recommended that all Indigenous Australians who are susceptible be offered vaccination against HBV.Chapter amended in response to comment -Duplicate comment - see #50Not applicable
164.5
Hepatitis B
13258Similarly, people born in intermediate-high HBV prevalence countries who remain susceptible to HBV are at higher risk of incident HBV infection than other members of the community, Adults born overseas in HBV endemic areas should also be recommended for HBV vaccination, again following serologic testing to ascertain for the presence of existing immunity or for established chronic hepatitis B infection. Chapter amended in response to comment -Duplicate comment - see #51Not applicable
84.5
Hepatitis B
1334When dealing with refugees, asylum seekers and/or migrants a broad definition of 'household contacts' may be required as communal living in a number of residences may be occurring. Therefore relevant discussions with the person living with hepatitis B need to be had regarding this issue to ensure all potential household contacts have the opportunity to be screened and/or vaccinated.Chapter amended in response to commentNot applicable
14.5
Hepatitis B
13328The term "people who inject drugs" needs to be used consistently.Chapter amended in response to commentNot applicable
14.5
Hepatitis B
13258As stated for Section 3.3: People born in endemic areas should be included as a recommended group for hepatitis B vaccination. Vaccination should also following serological testing.  The majority of chronic hepatitis B cases in Australia are seen in culturally and linguistically diverse (CALD) communities from countries where hepatitis B is endemic. Up to 1/3 of chronic hepatitis B cases in Australia are undiagnosed. If immigrants/refugees are not screened first, then it is not known if they already have chronic hepatitis B. If they have chronic hepatitis B, then the vaccination will only be useful for household contacts and/or sexual contacts.Chapter amended in response to commentNot applicable
14.5
Hepatitis B
12740-44The handbook should recognise that the greatest burden of hepatitis B infection on the Australian health care system relates to chronic hepatitis B infection (and related impact of cirrhosis and liver cancer), rather than the acute infection of adults.Chapter amended in response to commentNot applicable
14.5
Hepatitis B
13351Any inmate, rather than only those of long term correctional facilities, is at risk of hepatitis B infection as a result of inherent factors related to incarceration. Chapter amended in response to commentNot applicable
114.5
Hepatitis B
13111Suggest clarifying the difference between people with "imminent risk" and those requiring "prompt protection".Chapter amended in response to commentNot applicable
484.5
Hepatitis B
13258In the 'Recommendations' section under 'Adults', sex workers should be listed as a specific category recommended for hepatitis B vaccinations. Sex workers are a distinct group who share experiences of stigma and discrimination and are recognised as a ‘priority population’ by the Australian Government’s National HIV, STI  and Hepatitis B Strategies. Sex workers also include other ‘priority population’ communities who are Culturally and Linguistically Diverse (CALD), Men who have Sex with Men (MSM), Aboriginal and Torres Strait Islander (ATSI), Sex and/or Gender Diverse (SGD) and People who Inject Drugs (PWIDs). The National HIV Strategy speaks about ‘maintaining’ low rates of STIs/HIV among sex workers through continued investment in programs for priority populations. However, sex workers continue to face barriers to accessing vaccinations - current state and territory hepatitis B funding programs are ad hoc in their recognition of sex workers as an eligible group for funded vaccinations. Although voluntary testing remains the optimal model to HIV/STI testing in Australia’s National Strategies, sex workers face mandatory testing in some jurisdictions. A Scarlet Alliance survey on sex worker access to hepatitis B vaccinations demonstrates that sex workers face specific issues relating to cost of vaccination and the needs of people in regional/remote areas. Regulatory frameworks around sex work, including criminalisation and licensing, act as barriers to sex workers accessing vaccinations. Sex workers surveyed in Queensland and Victora, where licensing jurisdictions were in place, consistently showed lower levels of knowledge and access than in NSW, where sex work is decriminalised. Criminalisation of sex workers with an STI means that sex workers who suspect they may have contracted STIs may be reluctant undergo testing for fear of discrimination from their workplaces. Sex workers report stigma and discrimination in accessing health or service providers, including reluctance to engage with the health system due to past negative experiences, and fears about disclosing sex worker status for risk of prosecution. Trauma from discrimination in a sexual health clinic was given as a reason for one sex worker not completing a vaccination course.
There remain inconsistent policies across jurisdictions on the availability of free or subsidised vaccines for sex workers. It is crucial that sex workers be listed as a specific group under 'Adults' who are recommended for hepatitis B vaccination (not just 'those at occupational risk'). This is necessary to promote national consistency in groups and communities eligible for funded vaccination, to increase the uptake of vaccinations among priority populations. The Scarlet Alliance survey demonstrated that although sex workers had high levels of knowledge about hepatitis B vaccinations (90.6% knew there was a vaccination available) there was less awareness about the specific free/subsidised vaccinations available to them (only 50% of respondents knew if a free/subsidised vaccination was available to sex workers in their state), and even less knew about the cost or subsidy available for sex workers (only 28.1% said they knew how much sex workers were charged for vaccination). This can be linked to inconsistent policies on the availability of free or subsidised vaccines for sex workers across Australia. 13.6% of surveyed sex workers who had been vaccinated had to pay other consultation costs (for example, GP fees) in addition to the vaccination cost. Only 25% of VIC sex workers surveyed and 0% of QLD sex workers surveyed knew what sex workers would be charged for the vaccination. There is a clear need to address inconsistencies in state hepatitis B policy through making a clear recommendation in the Immunsation Handbook that sex workers are a distinct group who should be recommended for funded vaccinations. 
Chapter amended in response to commentNot applicable
484.5
Hepatitis B
1345In Section 4.5 on Hepatitis B, 'Sex industry workers' are included under the category of 'Others at risk'. The 9th Edition of the Immunisation Handbook outlined whether these groups 'should' be vaccinated or were 'encouraged' to be vaccinated. The10th Edition recommends that one group 'should' be vaccinated, but is silent on sex workers. This has implications for state and territory hepatitis B policies. State and territory policies on sex worker access to hepatitis B vaccinations remain inconsistent and ad hoc, with significant variation across jurisdictions. These inconsistencies translate into increased barriers to sex workers’ awareness of, access to and completion of the vaccine.Each state and territory differs according to who is considered a priority population, and again on who is eligible for funded vaccinations. Sex workers surveyed by Scarlet Alliance (figures presented in Joint Paper by Scarlet Alliance and the AIVL to BBVSS) demonstrate high rates of knowledge and awareness of vaccines, however less were aware about the cost or availability of vaccinations for sex workers in their state or territory. This reflects the ad hoc and inconsistent nature of hepatitis B programs, funding and priority populations across Australia. It is not enough for sex workers to be included as a dot point under 'others at risk'. Listing sex workers as part of the 'occupational risk' category has meant that sex workers have been forgotten in state and territory policies. A clear statement in the Immunisation Handbook recommends hepatitis B vaccinations for sex workers. This would send a clear message to drafters of state/territory policies that sex workers are a priority population and should be prioritised for vaccination. Chapter amended in response to commentNot applicable
484.5
Hepatitis B
13423-27There is no reference in the Handbook section on Post Vaccination Procedures that recommends follow-up testing for immunity generally. However,  there is a need to encourage course completion among sex workers to ensure immunity. AIVL has also raised this as an issue for drug users. Post-vaccination testing for immunity is relevant to sex workers, because vaccine completion rates are low and many sex workers do not know if they have finished their course. Some sex workers surveyed by Scarlet Alliance had misinformed assumptions about their immunity after only 2 injections. The Handbook recommends ‘serological confirmation of post-vaccination immunity’: Post-vaccination serological testing 4 to 8 weeks after completion of the primary course is recommended only for those in the certain categories, including ‘those at significant occupational risk (eg. healthcare workers whose work involves frequent exposure to blood and body fluids)’. This  arguably includes sex workers and drug users (although AIVL would be better placed to speak to these issues) because of our potential frequent exposure to blood and body fluids. There is a need to develop a more systematic policy approach to ensuring post-vaccination follow-up and testing to confirm immunity while still ensuring that fundamental rights in relation to confidentiality, informed consent and voluntary testing are at the basis. Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14439-40Consider revising the statement that a majority of men aged 19 years or greater are likely to have been exposed to one or more vaccine HPV types through sexual activity, or please provide a reference to support this. Note, in a study of 1,160 men aged 18-70 years, prevalence for HPV type 16 was 6.7 percent and HPV type 18 1.7 percent. Ref - Giuliano AR et al Canc Epi Biomarkers Prev 2008.Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
1425Suggest .addition of a statement regarding the attribution of HPV infection to cervical cancer (i.e. that virtually all CC cases are caused by HPV infection). Ref - Wallboomers et al. J Pathol 1999.Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14621For consistency with earlier recommendation (p145 line 3-4 and p146 line 17), suggest addition of 'with immunocompromising conditions'. If the intention is that where appropriate HPV vaccines may be used in females
45 years and older, please update variation from 4vHPV Product Information (p146 line 17) to also reflect this.
Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
1451Note recently published data on 4vHPV vaccination in patients with SLE, who are also immune suppressed (Mok CC et al. Ann Rheum Dis 2012).Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14114Suggest inserting 'recurrent' before 'respiratory papillomatosis' for consistency with line 29 below.Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14120-21Please note the Human Papillomaviruses-IARC Working Group on the Evaluation of Carcinogenic Risks to Humans (2005 Lyon, France) state there is sufficient evidence in humans for the carcinogenicity of HPV 16 in the cervix, vulva (basaloid and warty tumours), vagina, penis (basaloid and warty tumours), anus, oral cavity and oropharynx. Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14130Please note occurrence of adult onset recurrent respiratory papillomatosis (Derkay CS, Wiatrak B. Laryngoscope. 2008).Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14134-35Suggest inclusion of a statement regarding the possible acquisition of infection after a single sexual encounter, or encounters with one sexual partner with HPV infection, or in individuals who have not had sexual intercourse.  (Ref - Widdice LE, et al. Arch Pediatr Adolesc Med. 2012, Dempsey AF et al. Vaccine 2008).Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14230Please note on the 12 July 2012, the Australian Government announced the extension of GARDASIL on the National Immunisation Program (NIP) to include males. The NIP listing includes an ongoing program for males 12-13 years of age (similar to current female program) and a catch - up program over 2 years for Year 9 males. The program will commence in 2013.Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14234Consider updating 59 percent to 73 percent - updated data presented by Professor Basil Donovan at recent Public Health Association of Australia (PHAA) conference June 2012 Published in conference program and abstract book.No action requiredEditorial decision not to included data that is only available in conference abstracts
224.6 Human papilloma-
virus
14313-14For clarity consider stating 'The 2vHPV vaccine is not registered for use in males of any age'.No action requiredInformation provided in handbook
224.6 Human papilloma-
virus
14324Please note, interim data from the long term follow up study of women aged 16 through 26 years who participated in a pivotal GARDASIL efficacy study (FUTURE II) have been presented. From registry based data, a trend of continued protection was seen in 1,080 women who were vaccinated up to
7 years previously. No breakthrough cases of HPV 16,18 related CIN2 or worse were observed. Follow-up time in person-years is still insufficient to make a definitive statement regarding effectiveness. This study is ongoing with up to 14 years total follow up planned. Reference - Kjaer SK on behalf of the HPV Vaccine Nordic Follow-Up Team. An Evaluation of the Long term Effectiveness, Immunogenicity and Safety of GARDASIL in Previously Vaccinated Women. Abstract presented at EUROGIN, May 2011, Lisbon, Portugal.
No action requiredEditorial decision not to included data that is only available in conference abstracts
224.6 Human papilloma-
virus
14410Suggest providing further clarity (e.g. replace 'anogenital disease' with 'cervical cancer') as the registered indications of 4vHPV and 2vHPV vaccines in females are different. 4vHPV is indicated for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by HPV 6,11,16,18.2vHPV is indicated for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by HPV 16,18.No action requiredEditorial decision that wording for clinical recommendation in the handbook can be expressed differently to TGA registered indications.
224.6 Human papilloma-
virus
14422-23Suggest addition of 'Routine' at the beginning of this sentence given the funded catch-up program for females up to 26 years of age when the NIP program first began. Consider revising the statement that a majority of women aged 19 years or greater are likely to have been exposed to one or more vaccine HPV types through sexual activity, or please provide a reference to support this. Note, in a study of 2,152 Indigenous and non-Indigenous women aged 17-40 years, prevalence for HPV type 16 was
9.4 percent and 10.5 percent respectively and for HPV 18, prevalence was
4.1 percent and 3.8 percent respectively. Ref - Garland SM, et al. BMC Medicine 2011.
Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14428-29Suggest stating 'for prevention of persistent infection and anogenital disease caused by HPV 6, 11, 16, and 18'.Chapter amended in response to commentNot applicable
224.6 Human papilloma-
virus
14217-19Note reference to increasing incidence in HPV positive oropharyngeal cancer in lines 17 to 19. Suggest including a reference to increasing incidence of anal cancer, consistent with references 27 (Grulich et al Sexual Health 2010) and 30 (Jin et al  Vaccine 2011) Suggested text for consideration - The age-standardised incidence rate for anal cancer was 1.3 per 100,000 however, a slightly higher incidence was observed in females than males. The incidence of anal cancer in Australia has been steadily increasing over the past few decades, with higher annual rates of increase observed in males than in females (Ref 27, 30)Chapter amended in response to commentNot applicable
474.6 Human papilloma-
virus
14341-42I find trying to interpret at what age HPV vaccines are recommended for both males and females is incredibly confusing from page 143 to 146.  So many different ages are listed, in the end I could not confidently say what the upper age limits where for males or females.  This section could be improved if it was shortened considerably and succinctly listed the indication/recommendation/licencing ages for each sex.  The final statement on age is- "There is no upper age limit for the use of the 4vHPV vaccine in adult MSM."  and then "There is no upper age limit for the use of the 4vHPV vaccine in adults of either gender with immunocompromising conditions.  What about the ones who aren't immunocompromised?Chapter amended in response to commentNot applicable
114.6 Human papilloma-
virus
14331Please note that two-dose schedules of both HPV vaccines are being studied.Chapter amended in response to commentNot applicable
284.7 Influenza15447Advises there are two intradermal flu vaccines available, but only 1 vaccine is listed in purple box on same page (intanza).Chapter amended in response to commentNot applicable
24.7 Influenza19158The sentence could also include that vaccination of swine industry workers will reduce the risk of infected humans transmitting infections to pigs through reverse zoonoses, as was seen during H1N1.Chapter amended in response to commentNot applicable
94.7 Influenza15537General note ... does the chapter need to include information that Fluvax is not registered for, and must not be given to children less than 5 years of age.Chapter amended in response to commentNot applicable
104.7 Influenza15536A separate note needs to be added for Fluad as follows:
Fluad is registered for use only in persons 65years and over. Fluad should be shaken gently before injection due to the presence of the adjuvant. Fluad should be administered only by IM injection.
Chapter amended in response to commentNot applicable
104.7 Influenza15410Novartis Vaccines has two licensed influenza vaccines: Agrippal (TIV) and Fluad (adjuvanted TIV). Whilst Fluad has not been distributed in Australia, it has been listed in previous Immunisation Handbooks, is still licensed in Australia and may be distributed in Australia in the future. As such, an additional vaccines should be added to the existing list of vaccines as follows:
Fluad Novartis Vaccines & Diagnostics Pty Ltd (inactivated influenza virus). Each 0.5 mL pre-filled syringe contains 15 ¼g haemagglutinin of the 3 recommended strains, adjuvanted with MF59C.1. May contain traces of kanamycin, neomycin, formaldehyde and egg protein. 
Chapter amended in response to commentNot applicable
244.7 Influenza15318Typo? November 2012 should either be November 2009,  November 2010 or November 2011 (I couldn't find the reference for this statistic to verify actual date).Chapter amended in response to commentNot applicable
224.7 Influenza1544715mcg is registered but not available. Suggest to include comment that only one formulation (9mcg) is available to avoid confusion.  Chapter amended in response to commentNot applicable
114.7 Influenza15318Please note reference to "November 2012" which is a future date.Chapter amended in response to commentNot applicable
114.7 Influenza15447-51Two intradermal vaccines are mentioned and only formulation of the vaccine is referenced.Chapter amended in response to commentNot applicable
114.7 Influenza15649For clarity amend to - total number of exacerbations.Chapter amended in response to commentNot applicable
114.7 Influenza1575For clarity - delete "or".Chapter amended in response to commentNot applicable
114.7 Influenza15820For clarity amend to - who is infected.Chapter amended in response to commentNot applicable
114.7 Influenza15840-41Please note this recommendation is not in line with the Fluarix® Product Information leaflet.No action requiredInformation  included in handbook
114.7 Influenza15846-47Please note this recommendation is not in line with the Fluarix® Product Information leaflet.No action requiredInformation  included in handbook
114.7 Influenza1593Please note this recommendation is not in line with the Fluarix® Product Information leaflet.No action requiredInformation  included in handbook
114.7 Influenza15930Please note that the estimate of frequency of adverse events differs in the Fluarix® Product Information leaflet.No action requiredEditorial decision to not include specific safety data for each individual influenza vaccine unless specific safety issue needs to be highlighted.
114.7 Influenza15945Please note this recommendation is not in line with the Fluarix® Product Information leaflet.No action requiredInformation  included in handbook
304.7 Influenza15429-32With its recent positive PBPA recommendation for listing on the NIP, could Intanza 15mcg be listed under 'Vaccines for intradermal vaccination' please?Chapter amended in response to commentNot applicable
404.7 Influenza15435I am not sure that it can be said that the safety is equivalent, as the CSL influenza vaccine has a different safety and adverse event profile (and manufacturing is somewhat different). It is my opinion that there needs a paragraph on the CSL influenza vaccine (perhaps after line 47) discussing some its issues including its age restrictions. It seems inconsistent to list age restrictions on the intradermal vaccine, and name the product, and then not do it for Fluvax. This also applies to Line 37 on age 155. I would imagine that the age restriction on the CSL influenza vaccine will remain for at least a few years.Chapter amended in response to commentNot applicable
404.7 Influenza15245Perhaps it would be more accurate to read estimates or modelling rather than studies?Chapter amended in response to commentNot applicable
404.7 Influenza15223-25Reference 2 does not address the facts in these statements, particularly the household attack rate. There are other refs that do address these.
Perhaps this statement on asymptomatic disease in Line 31 would be better placed with the attack rate statement too.
Chapter amended in response to commentNot applicable
404.7 Influenza1525Grammar correction - should be antigens are (not is).Chapter amended in response to commentNot applicable
404.7 Influenza1559Also were different vaccines used adjuvented vaccines used in Europe?Chapter amended in response to commentNot applicable
404.7 Influenza15627It is my opinion that the evidence should not be called strong, as there are no significant trials (only small ones) and mainly post-marketing experience, of which some has had questionable outcomes in the first trimester (eg JAMA 2012;308(2):165-74 although for a different influenza vaccine).
In addition, I am particularly concerned at the lack of demonstrated safety in pregnancy (particularly first trimester) of the CSL influenza vaccine, especially in the context of studies showing an excess of cytokeine production by this vaccine. Until there is enhanced surveillance results or specific trials, perhaps there needs to be a line about the provider considering or discussing brand preference with a patient in the first trimester of pregnancy. (also refers to page 158, line. 40)
Chapter amended in response to commentNot applicable
404.7 Influenza15623The reference mmwr 29 actually says "These studies have been challenged because of concerns that they have not controlled adequately for differences in the propensity for healthier persons to be more likely than less healthy persons to receive vaccination".Chapter amended in response to commentNot applicable
404.7 Influenza1599Should the requirement for extended observation post vaccination in egg (or other) allergy be included, as this is another essential component of the safer management (and I believe that most immunisation providers may think that they satisfy the other stated requirements - can recognise and treat anaphylaxis).Chapter amended in response to commentNot applicable
404.7 Influenza15829Could/should there be a reference included for this?Chapter amended in response to commentNot applicable
404.7 Influenza15629Not sure that the word strong should be included, based on the one Zaman paper?Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis1661See also Hills et al 2010 Am J Trop Med Hyg 82, 5, pp 930-36.Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis16516-17ATAGI Advice on Variations from PI noted re paediatric use Note that the paediatric development of JESPECT is ongoing - Completion of a pivotal Phase III trial (IC51-323) in children aged 2 months to less than 18 years conducted in the Philippines. Results presented at the Asia Pacific Travel Health Conference in Singapore, May 2012 by K. Dubischar-Kastner (Abstract available). A second Phase III trial (IC51-322) in children aged 2 months to less than 18 years in Europe, U.S. and Australia (non-endemic countries) is ongoing with interim results presented at the 4th NECTM conference
June 6-8 2012 Abstract available online.
Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis16534Suggest changing to 'It has been determined that JESPECT has at least equivalent immunogenicity (after 2 doses, given 4 weeks apart) to 3 doses of the previously available mouse-brain derived vaccine (JE Vax)'. As travellers frequently present late for pre-travel immunisations, consider including information about the rate of protection after a single dose, the onset of protection after two doses and the response to a delayed completion of the schedule. (Schuller et al, Vaccine 2009 27 p 2188 -2193 and Dubischar Kastner et al Vaccine 2010 28 pp5197-5202.)Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis16424We note that the National Notifiable Diseases Surveillance System codes as 'Japanese Encephalitis virus infection' however should these cases read as JE disease?DisagreeEditorial decision to report data as it is reported by the National Notifiable Disease Surveillance System
224.8 Japanese encephalitis16534Suggest placing 'Clinical and animal studies have provided evidence in support of an immunological correlate of immunity (established by the World Health Organization as a neutralising antibody titre of greater than or equal to 1 in 10), JEspect was registered on the basis of this serological correlate in lieu of a field efficacy trial' before line 48 as this applies to both Jespect and Imojev. As per the Imojev AusPAR, in the clinical development program of Imojev, a serological correlate of protection was used for demonstration of efficacy. The serological correlate was based on neutralising antibodies as recommended by WHO. Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis1651Note range of seroprotection at 12 months is 58 to 83 percent
(Ref 12,13). Additional booster data is available - 1. Eder et al. Vaccine 2011, 29, 2607-2612 also included in JESPECT PI - Clinical Trials Booster immunisation (Booster dose administered administered 15 months following primary immunisation, neutralising antibody titres assessed at 1, 6 and 12 months following booster) and 2. ACIP recommendations for use of a booster dose of inactivated vero cell culture-derived Japanese encephalitis vaccine. MMWR 2011, 60(20), 661-663 (Recommendations based on two clinical trials - Eder et al. 2011 and Dubishar-Kastner et al. 2010.).  In Dubischar et al, the booster dose was administered only to subjects whose titers had dropped below protection, whereas in the study Eder et al booster doses were given to all persons, regardless of their serostatus. 
Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis16631-32Note reference by Eder et al. Vaccine 2011, 29, 2607-2612  - A mathematical model was applied to estimate the persistence of antibodies beyond 12 months following a booster of JESPECT administered 15 months after the primary series. The modelling suggested that the majority of vacinees would maintain protective levels of antibodies for at least 4 years Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis16630ACIP recommends that if the primary series was administered greater than 1 year previously, a booster dose may be given before potential JE virus exposure. (MMWR 2011, 60(20), 661-663). Therefore, suggest changing
'12 months following receipt of their 1st dose' to '12 months following the primary series'.
Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis16616Note that previous edition referred to Residents of Far North Queensland.No action requiredThe handbook has been updated to reflect current epidemiology
224.8 Japanese encephalitis16621 week is in line with the JESPECT Approved Product Information. The Imojev Approved Product Information states 14 days for seroprotection.Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis16518-19Recent data available regarding the use of JESPECT to boost people previously vaccinated with JE Vax - 1. Woolpert et al. Vaccine 2012, 30(20), 3090-6. 2. Erra et al. Clin Inf Dis. 2012,  Advance Access published July 9.Chapter amended in response to commentNot applicable
224.8 Japanese encephalitis16445-46Change JEspect to JESPECT throughout Handbook as per Product Information. Suggest changing '0.25mg aluminium hydroxide' to
'0.1 per cent aluminium hydroxide, hydrated corresponding to 0.25 mg aluminium' or, '0.1 per cent aluminium hydroxide, hydrated' or, '0.25mg aluminium' as per the JESPECT Approved Product Information.
Chapter amended in response to commentEditorial decision not to capitalise vaccine names
304.8 Japanese encephalitis1651The text states: Several trials have demonstrated that single dose of Imojev induced protective levels of neutralising antibodies in both children and adults, 1 month following vaccination. In adults there is data to show that Imojev produces protective levels of neutralising antibodies at 14 days. Imojev induced neutralising immunity in 93.6% of adults at 14 days. (ref. Imojev PI, page 2, Clinical Trials).Chapter amended in response to commentNot applicable
304.8 Japanese encephalitis16441The text incorrectly states that IMOJEV comes with a prefilled diluent syringe. This product comes with a lyophilised powder vial, a diluent vial, a syringe and two needles.Chapter amended in response to commentNot applicable
304.8 Japanese encephalitis1653The text states: Seroprotection was found to persist for at least 6 months after vaccination in children aged 12 months to 5 years. In children aged 2-5 years old seroprotection rates were 97% at 12 months; in infants aged 12-24 months, seroprotection rates at 12 months were 84%. (ref. #9) We propose that this sentence is changed to read: Seroprotection rate was found to persist for 12 months after vaccination in children aged 12 months to 5 years. In children aged 2-5 years old seroprotection rates were 97% at 12 months; in infants 12-24 months, seroprotection rates at 12 months were 84%. (ref. #9)Chapter amended in response to commentNot applicable
304.8 Japanese encephalitis1654In older persons, seroprotection has persisted for at least 48 months after vaccination
 1. older persons implies elderly, where the trial was in adults. I would change the wording to "adults" rather than "older persons".
2. 2The trial (ref 10) actually showed that seroprotection persisted for 60 months after vaccination. This is consistent with the statement on page 166, line 31.  
Chapter amended in response to commentNot applicable
414.9 Measles17210To reduce variability in interpretations, it would be very helpful to define the terms of protection and ‘immune’ in relation to the actions required for vaccination of health care workers whose  serology results are:
a) positive (also referred to as 'detected'); 
b) low positive (may be indicated by a range or value); 
c) equivocal (may be indicated by a range or value);
d) negative (also referred to as 'not detected') 
This is similarly illustrated in table 4.15.1, page 227.
Alternatively, should we be guided by the comment/interpretation made by the laboratory that is documented on the serology report?  e.g. 'Low positive: Low levels Measles IgG antibody detected.  This may NOT correlate with protective immunity' (cited in a hospital laboratory report).  If so, could this be clearly stated in the handbook?
Chapter amended in response to commentNot applicable
24.9 Measles1728-13Include carers, and staff of long term care facilities and home careChapter amended in response to commentNot applicable
94.9 Measles1728Include inmates of correctional facilities in recommendations for vaccination as they are mentioned in 'Special risk group' chapter ie Heading "Staff and inmates of correctional facilities, health care workers ...." as NSW has had a large outbreak in these facilitiesChapter amended in response to commentNot applicable
54.9 Measles17036An example of a cell line notation.No action requiredComment did not require an action
224.9 Measles17122Suggest addition of Table 4.22.1 from Chapter 4.22 (Varicella)p 288 at the end of this section to help clarify recommendations for MMR vaccination with  MMR vaccines and MMRV vaccines (once available from July 2013)Chapter amended in response to commentNot applicable
224.9 Measles17017Please include  M-M-R-II in all relevant sections of this chapter.
M-M-R-II is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no M-M-R-II used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL intends to submit a response for M-M-R-II when the measles, mumps and rubella Request for Tender is issued later this year.
Chapter amended in response to commentNot applicable
224.9 Measles17013-14Please note current data for MMRV vaccines does not support this vaccine effectiveness statement. Consider deletion of this statement to avoid possible confusion.Chapter amended in response to commentNot applicable
224.9 Measles16934The date of the campaign is mentioned later on in this paragraph (line 42), consider deleting the date from line 42 and inserting it  here where the campaign is first mentioned.Chapter amended in response to commentNot applicable
224.9 Measles17124-26Note this sentence is somewhat inconsistent with page 176 line 15-16 which states 'The ATAGI also recommends that MMRV vaccine should not be used as the 1st dose of MMR-containing vaccine in young children unless discussed with the relevant state or territory public health authorities.' Consider inclusion of latter text to page 171 for consistency. Please ensure all relevant chapters (measles, mumps, rubella and varicella) are consistent regarding this.Chapter amended in response to commentNot applicable
124.9 Measles17450"The use of 50 aspirin after MMRV vaccination is not recommended for 6 weeks (see Chapter 4.22, Varicella)." But in the Varicella chapter p290 line 44 it says the opposite and again in the Varicella section on Variations with PI p 293 p20-23. Please review the recommendation for no aspirin 6 weeks after MMRV on p 174.Chapter amended in response to commentNot applicable
114.9 Measles1757This paragraph does not include the PASS study data supplied to ATAGI in May 2012.  The data is currently embargoed (embargo to be lifted at the end of August) although could be considered for the Handbook given publication will be  in late 2012.No action requiredPASS data currently unpublished
114.9 Measles18547-48Please note 4vMenPV is still available.  Suggest amending to - the product information for all MenCCVs, 4vMenPVs and 4vMenCVs state that there are no data on there use of these vaccines in lactating women.  Chapter amended in response to commentNot applicable
14.10 Meningococcal disease18120Quantity of aluminium hydroxide in each 0.5mL syringe of Neisvac is 1.4 mg, not 0.5 mg. Please refer to www.tga.gov.au for the latest Neisvac PI and ARTG entry.Chapter amended in response to commentNot applicable
524.10 Meningococcal disease1845-7This is a new recommendation and needs to be highlighted in the What's New section.Chapter amended in response to commentNot applicable
134.10 Meningococcal disease18417The recommendation for a 2-dose primary 4vMenCv for asplenic persons on page 184 line 17 (2 doses: >2 years and <55 years, 1 dose 9mo-2 years and >55 years) is at odds with the recommendation on page 91, line 2 (2 dose primary for all >9 months). A table may make these recommendations clearer, as different age limits are also mentioned on page 185. Chapter amended in response to commentNot applicable
134.10 Meningococcal disease18433Revaccination with 4vMenCV lines 33-35 on page 184 would better follow the text on line 28, as they both deal with immunocompromised individuals.Chapter amended in response to commentNot applicable
134.10 Meningococcal disease18528Page 185 It would be worth pointing out that the Menveo and Menactra PIs both state that the need for, or timing of, a booster dose of these vaccine has not yet been determined , whereas the Handbook is recommending a 2 dose-primary schedule and 5 year booster doses for this group.Chapter amended in response to commentNot applicable
104.10 Meningococcal disease18114Change from "Novartis Vaccines" to "Novartis Vaccines & Diagnostics Pty Ltd".Chapter amended in response to commentNot applicable
104.10 Meningococcal disease18131Change from "Novartis Vaccines & Diagnostics Pty Ltd" to "CSL Limited/Novartis Vaccines & Diagnostics Pty Ltd"Chapter amended in response to commentNot applicable
104.10 Meningococcal disease18133Because there are now two licensed presentations of Menveo (vial-syringe plus now vial-vial), in addition to the existing (vial-syringe) presentation on line 32, an additional (vial-vial) presentation needs to be added as "Lyophilised powder containing serogroup A in a monodose vial with a vial containing serogroups C, W135 and Y in saline suspension". The remainder of the description on lines 33,34,35 is correct for both presentations.Chapter amended in response to commentNot applicable
104.10 Meningococcal disease18134Change 33 to 33.3.Chapter amended in response to commentNot applicable
104.10 Meningococcal disease18344The ATAGI advice on variations from product information is noted.No action requiredComment did not require an action
104.10 Meningococcal disease1844Additional recommendations for immunisation with 4vMenCV include:
" All students intending to attend US based colleges and universities. This is in line with the recommendations from the American Advisory Committee on Immunization Practices (ACIP), for vaccination of college freshmen with a meningitis A,C, W135 and Y booster prior to entering a US college
" All students entering Australia from meningitis endemic areas
" Individuals who travel extensively and unpredictably e.g. military and intelligence personnel, flight attendance and cabin crews
" Travellers visiting areas at risk of meningococcal disease whose planned activities put them at higher risk including healthcare workers, international volunteers or aid personnel, those visiting friends and relatives and long-term travellers who have close contact with the local population.
DisagreeThere is a statement in chapter 3.2 Travel, around the need to consider any policies requiring demonstration of vaccination/ immunity in place in some international organisations such as schools.
464.10 Meningococcal disease18516Public health advice is more streamlined referring detailed advice to State jurisdictions. Introduction of 4vMenCV and indications for use is welcomed. The Handbook notes the intention to add Hib-MenCCV to the schedule.Chapter amended in response to commentComment did not require an action
224.10 Meningococcal disease18114Please change Menjugate Syringe to read CSL Limited and Novartis Vaccines and Diagnostics Pty Ltd.Chapter amended in response to commentNot applicable
224.10 Meningococcal disease18131-35Please include CSL Limited as the distributor of Menveo and the following - Two presentations are supplied - 1. Lyophilised powder containing serogroup A in a monodose vial with a pre-filled syringe containing  serogroups C, W135 and Y in saline suspension. 2. Lyophilised powder containing serogroup A in a monodose vial with a vial containing serogroups C, W135 and Y in saline suspension. Each 0.5 mL reconstituted dose contains 10 micrograms of serogroup A and 5 micrograms each of serogroups C, W135 and Y oligosaccharides individually conjugated with up to 33.3 micrograms of non toxic Corynebacterium diphtheriae CRM197 protein, sucrose.Chapter amended in response to commentNot applicable
224.10 Meningococcal disease18545ATAGI Advice on Variations from Product Information noted.No action requiredComment did not require an action
234.10 Meningococcal disease18045-46In other countries who introduced a meningococcal C vaccination program etc Suggest to replace (who) with (that) in the phrase above.Chapter amended in response to commentNot applicable
304.10 Meningococcal disease1824Several clinical trials have demonstrated the immunogenecity of 4vMenCV, with human serum bactericidal assay titres of >1:4 in adolescents and young adults. Similarly, only Menveo studies are cited to support this statement. We suggest adding this reference for balance:
 Keyserling, H, Papa, T, Koranyi, K et al. Safety, immunogenecity and immune memory of a novel meningococcal (Groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in health adolescents. Arch Pediatr Adolesc Med 2005; 159, 907-13
Chapter amended in response to commentNot applicable
304.10 Meningococcal disease185 Presented to ACIP (23/06/10): "Reports of GBS within 6 weeks of Menactra vaccination initially observed during the first year of distribution" - assessed in a very large epidemiological study (Harvard Pilgrim Study), results showed no evidence of increased risk associated with Menactra. A study from the Vaccine Safety Datalink project which was a collaborative effort between the Centres for Disease Control and Prevention and several managed care organsations in the US reached the same conclusion.Chapter amended in response to commentNot applicable
304.10 Meningococcal disease1824There have been a number of studies examining 4vMenCV in children. The current references cited to support this statement all relate to Menveo. Request addition of two Menactra references: Pina LM, Bassily E, Machmer A et al. Safety and immunogenicity of a quadrivalent meningococcal polysaccharide diphtheria-toxoid conjugate vaccines in infants and toddlers: Three multicentre phase III studies. Pediatr Infect Dis J 2012; in press. doi: 10.1097/INF.0b013e318268dfe4 Pichichero M et al. Comparative trial of the safety and immunogenicity of quadrivalent (A, C, Y, W135) meningococcal polysaccharide-diphtheria conjugate vaccine versus quadrivalent polysaccharide vaccine in two to ten-year old children. Pediatr Infect Dis 2005;24:57-62.Chapter amended in response to commentNot applicable
114.10 Meningococcal disease18242-43Please note Hib-MenCCV is registered to be given at any age, including in children at 12 months of age as a primary dose serogroup C meningococcal vaccine and the booster dose of Hib vaccine.Chapter amended in response to commentNot applicable
224.11 Mumps1901Please include  M-M-R-II in all relevant sections of this chapter.
M-M-R-II is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no M-M-R-II used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL intends to submit a response for
M-M-R-II when the measles, mumps and rubella Request for Tender is issued later this year.
Chapter amended in response to commentNot applicable
224.11 Mumps1914Suggest addition of Table 4.22.1 from Chapter 4.22 (Varicella) p 288 at the end of this section to help clarify recommendations for MMR vaccination with  MMR vaccines and MMRV vaccines (once available from July 2013).DisagreeEditorial decision to only include Table 4.22.1 to chapter 4.22 Varicella, and chapter 4.9 Measles
224.11 Mumps1911Note this sentence is somewhat inconsistent with varicella and measles chapters which states 'The ATAGI also recommends that MMRV vaccine should not be used as the 1st dose of MMR-containing vaccine in young children unless discussed with the relevant state or territory public health authorities.' Consider inclusion of latter text to page 191 of the Mumps chapter for consistency. Please ensure all relevant chapters (measles, mumps, rubella and varicella) are consistent regarding this.  Chapter amended in response to commentNot applicable
394.12 Pertussis19813Clarification on evidence, and should we be giving dTpa to pregnant women opportunistically at our clinics? Chapter amended in response to commentATAGI decision to recommend booster if not previously vaccinated in previous 5 years for women planning pregnancy, pregnant or post-partum 
124.12 Pertussis1943The characteristic paroxysmal cough with inspiratory whoop seen in unvaccinated children is less common in very young infants and older children and adults who have varying degrees of immunity acquired from vaccination or infection. Seems all ages do not have characteristic cough if some immunity so remove reference to age in this sentence. Chapter amended in response to commentNot applicable
304.12 Pertussis19521-39Would it be possible to please include in the list of available vaccines Sanofi Pasteur's products TRIPACEL and PEDIACEL?Chapter amended in response to commentNot applicable
114.12 Pertussis19534For antibodies to PT and FHA (lower GMC than pre-vaccination). Antibodies to PRN were 2x prevaccination levels (GMC). Suggest the following text change in line with the reference - 'with pertussis antibody levels decreasing to or approaching prevaccination levels after 10 years.'Chapter amended in response to commentNot applicable
114.12 Pertussis1977GSK note the difference between the Handbook recommendation (11-13 years) and the NIP schedule (10-17 years).  Should this be noted in the Handbook?Chapter amended in response to commentNot applicable
114.12 Pertussis19718The rationale for restricting the use of the vaccine to 60-65 years is not clear.  Suggest amending text to 'adults aged ≥60 years'.Chapter amended in response to commentNot applicable
114.12 Pertussis19733Please note this recommendation is not in line with the Boostrix® Product Information leaflet.Chapter amended in response to commentNot applicable
114.12 Pertussis19813Please note this recommendation is not in line with the Boostrix® Product Information leaflet.Chapter amended in response to commentNot applicable
114.12 Pertussis19841Please note that additional contraindications are contained in the Boostrix®, Boostrix®-IPV, Infanrix® hexa and Infanrix® IPV Product Information leaflets.Chapter amended in response to commentNot applicable
114.12 Pertussis19940The inclusion of the case definitions for all diseases was useful.  Suggest pertussis case definition is re-instated.Chapter amended in response to commentNot applicable
114.12 Pertussis20026-27Boostrix® and Boostrix® IPV Product Information leaflets also state these vaccines should not to be given within 5 years of dT.  Suggest inclusion of these vaccines in the 'variation from the Product Information' section.Chapter amended in response to commentNot applicable
124.13 Pneumococcal disease21131Presence f a condition typo only should be " of a condition. Chapter amended in response to commentNot applicable
224.13 Pneumococcal disease20423As S. pn. found in CSF would also qualify as IPD, suggest that this line is altered to read 'To be also classified as IPD, isolation of S. pneumoniae in sputum is not sufficient, it must also be isolated from a normally sterile site such as the blood or cerebrospinal fluid'.Chapter amended in response to commentNot applicable
224.13 Pneumococcal disease20649-50Suggest including results from 15 RCTs (n 48656) also included in the Cochrane review. Given efficacy against all-cause pneumonia was inconclusive with substantial heterogeneity seen, and as all-cause pneumonia is an indirect measure of vaccine efficacy, consider replacing all-cause pneumonia with pneumococcal pneumonia results. Please note, an update to the 2008 Cochrane review is expected to be released shortly, consider incorporating results from this update into this text.No action requiredEditorial decision that results from Cochrane review are already appropriately expressed
224.13 Pneumococcal disease2072Please note the following additional references pertinent to vaccine effectiveness - Maruyama T, et al. BMJ. 2010, Spindler C, et al. Vaccine 2008, Mooney JD, et al. BMC Infect Dis 2008Chapter amended in response to commentNot applicable
224.13 Pneumococcal disease2074Please note the recently published review - Grabenstein JD, Manoff SB. Vaccine. 2012Chapter amended in response to commentNot applicable
224.13 Pneumococcal disease20713Suggest reversing order so that IM is before SC. In addition suggest addition of text from page 213 line 51-53 '3-fold greater rate of injection site reactions is found following administration of 23vPPV by the subcutaneous route, therefore the intramuscular route is preferred. However, a vaccine dose administered subcutaneously does not need to be repeated'.Chapter amended in response to commentNot applicable
224.13 Pneumococcal disease20725-27Please ensure text is consistent with recommendations in Chapter 4.24 Zoster (Herpes Zoster) - please see comments to this chapter.Chapter amended in response to commentNot applicable
224.13 Pneumococcal disease2117Suggest further explanation regarding hyporesponsiveness is required here, particularly regarding the impact of timing between doses (please see Grabenstein JD, Manoff SB. Vaccine. 2012). Suggest addition of the following statement taken from ATAGI December 2011 advice - 'Blunting of antibody response to repeat doses of pneumococcal vaccines may occur, however, the evidence on this is not consistent, and the interval between the 23vPPV doses may be a factor. Whether immune hyporesponsiveness has any significant detrimental outcome on vaccine effectiveness remains unknown'.Chapter amended in response to commentNot applicable
224.13 Pneumococcal disease21131Note typographical error 'of' rather than 'f'Chapter amended in response to commentNot applicable
224.13 Pneumococcal disease21244-47Please ensure text is consistent with recommendations in Chapter 4.24 Zoster (Herpes Zoster) - please see comments to this chapter.Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease20410It would be better to use more recent reference. the 2007/2008 report is in press.No action requiredEditorial decision to only include published data
144.13 Pneumococcal disease20914-18The last 2 sentences contradict each other. Could say 'as soon as the condition is identified providing there is a minimum 2-month interval between 13vPCV dose and 23vPPV'. Then would not need last sentence currently on line 17-18.Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease20919-27List 4.13.1 Needs to have different headings. The title of this list and the two sub headings are very similar and this adds to the confusion in trying to read the text in lines 19-26 which are very difficult to understand anyhow. Not sure of the best way to change lines 19-26 but suggest they be simplified as much as possible. Is there anyway the text can explained by a table?Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease2105This  infers that an Indigenous child aged 16 to <18 yrs of age recently diagnosed with one of the specified medical conditions is not entitled to receive a dose of 13vPCV whereas a non Indigenous child this age is. Why cant it be all persons up to age 18yrs?Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease21016Need to  change guideline to include all  persons aged 5-<18yrs NOT just non Indigenous.  Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease21024Should this table be recommendations for 're vaccination'?  and the 1st dose of 23vPPV (column 2) be 'Age 1st dose of 23vPPV given? Otherwise it doesn't make sense to have an option 'Yes or No' in row 8 of the table. If the table was just for revaccination the text in rows 17-19 need to be changed.Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease2110Suggest replacing the word 'reaching' with 'at' in line 1. This text would be better if it came before table 4.13.3Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease2116suggest this be reworded and combined with the text on lines 31-34 and should sit after list 4.13.2.Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease2110Only need to include the last sentence of this paragraph....of age is uncertain and 'should not be counted as a prior dose of 23vPPV.  The rest of paragraph does not really add any value.
Do need to state however there should be at least 5 years since any previous childhood dose. EG: you don't want a child being given a dose at age 13 and then again at age 15.
Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease21141-48In the NT we have always used the rule the vaccine 23vPPV schedule for Indigenous persons is at age 15, 20 and 50 yrs of age. This section is suggesting we give dose 1 at age 15 and dose 2 at 5 years after only if they have a specific condition as per table 4.13.3. All other Indigenous persons should wait until they are aged 50 for dose 2 or when they develop a condition as per list 4.13.2.  We currently have recall/reminder systems in place for those requiring revaccination
(5 yrs after dose 1 and at age 50) and we would not be able to continue to do this with the recommendations in this draft. 
Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease21217-18This contradicts that in high risk individuals 13vPCV can be given up to age
18 yrs. This DOES include those that may be pregnant or breast feeding.
Chapter amended in response to commentNot applicable
144.13 Pneumococcal disease20521-54The use of acronyms or words in full are not consistent for IPD, 23vPPV, 7vPCV and 13vPCV throughout this section.Chapter amended in response to commentNot applicable
364.13 Pneumococcal disease2064Possibly would read better if structured: "7vPCV is no longer available, having been replaced in 2011 by the extended valency 13-valent pneumococcal conjugate vaccine (13vPCV), made by the same manufacturer".Chapter amended in response to commentNot applicable
364.13 Pneumococcal disease20712Might be an appropriate time to express WHY give the pneumococcal vaccine in a separate limbNo action requiredThis is a general principle so does not require further explanation
364.13 Pneumococcal disease20718-19Influenza vaccine is specifically mentioned re concurrent administration - I would argue that this sentence be taken out of here and left in the section immediately below this point: "Co-administration with other vaccine". Also, if specifically mentioning you CAN administer with influenza vacc, then possibly mention MMR and DTPa-IPV also, as many medically-at-risk kids will get Pneumovax23 with their 4 year old needles. Chapter amended in response to commentNot applicable
364.13 Pneumococcal disease2081In this table, Indigenous children in NT, Qld, SA or WA are recommended to have a 13vPCV at 12-18 months - this has obviously changed from the 9th ed. Handbook which advises this 4th dose to be given at 18-24 months?No action requiredThe preferred time for 13vPCV is at 12-18 months.  This has been updated since the 9th edition
364.13 Pneumococcal disease21123I think the   *   is meant to be attached to asthma, but rather it sits after the comma, closer to the word diabetes: "severe asthma, * diabetes, and alcohol-related problems".Chapter amended in response to commentNot applicable
114.13 Pneumococcal disease2059Text does not reflect that Synflorix became available in Australia in 2009 and that Synflorix was used in NT between Oct 2009 and Oct 2011.  Suggest text be amended to include this missing information.Chapter amended in response to commentNot applicable
114.13 Pneumococcal disease20615Text should be amended so that immune difference in immune response of
3 or 4 doses is in alignment for PCV10 and PCV13.  Synflorix is indicated as a two dose primary schedule (+ booster); PCV13 is not.
Chapter amended in response to commentNot applicable
114.13 Pneumococcal disease20715Synflorix is indicated for children up to 5 years of age, not 2 as stated.  Suggest amending text to state - 10vPCV is registered for use in infants and children from the age of 6 weeks up to 5 years.Chapter amended in response to commentNot applicable
114.13 Pneumococcal disease20720Please note that coadministration data is also available for 10vPCV (Synflorix®).  Suggest inclusion of this information in this chapter.Chapter amended in response to commentNot applicable
114.13 Pneumococcal disease2081suggest Table 4.13.1 also reference 10vPCV.Chapter amended in response to commentNot applicable
114.13 Pneumococcal disease20814As a registered vaccine listed for use on the NIP, suggest catch-up schedules for 10vPCV also be included in the Handbook.Chapter amended in response to commentNot applicable
114.13 Pneumococcal disease2091Suggest reference to 10vPCV also be included in Table 4.13.2.Chapter amended in response to commentNot applicable
114.13 Pneumococcal diseaseNot applicableNot applicablePlease note that data is also available for the use of 10vPCV in preterm infants and this could be included in the Handbook.Chapter amended in response to commentFurther information has been added in chapter 3.3 
284.14 Poliomyelitis2215Advises 2 month interval between polio vaccine doses, but minimum interval table page 18 advises only 4 weeks between doses.Chapter amended in response to commentNot applicable
284.14 Poliomyelitis22119Should advise both Infanrix hexa and Infanrix IPV can be used for catch up as per p222 lines 19-20.Chapter amended in response to commentNot applicable
124.14 Poliomyelitis2215The primary course consists of 3 doses of vaccine. An interval of
2 months between doses is recommended, but the 6 minimum interval can be as short as 1 month for catch-up in older children or adults. The words ''in older children and adults'' have been added from 9th ed but this makes no sense in the given context of the primary course catch up which relates to infants. The new wording excludes advice for the catch up fro infants primary course with combination vaccines and this would need to be added if the words ''in older children and adults need to remain.
Chapter amended in response to commentNot applicable
14.15
Q fever
22426Camels, kangaroos and bandicoots should also be identified as potential reservoirs of infection, to be consistent with line 11 on page 226. (Ref:
Potter AS et al 2011, 'Prevalence of Coxiella burnetii in western grey kangaroos (Macropus fuliginosus) in Western Australia', Wildl Dis, 47(4):
821-8; Cooper A et al 2011, 'Serological evidence of Coxiella burnetii exposure in natural marsupials and introduced animals in Queensland, Australia', Epidemiol Infect doi: 10.1017/S0950268811001828). 
Chapter amended in response to commentNot applicable
44.15
Q fever
2241Reviewed TB and Q Fever chapters - no changes.No action requiredComment did not require an action
224.15
Q fever
2271Please note that the reference cited is no longer available Please change reference to - 'with modifications from A guide to Q fever and Q Fever vaccination (CSL Biotherapies, 2009).'Chapter amended in response to commentNot applicable
224.15
Q fever
22634-35Please note that CSL Limited does not keep a record of immunisation service providers so this line should be removed or changed to direct readers to an alternative source of this information.Chapter amended in response to commentNot applicable
224.15
Q fever
2264As training is via an educational video on a password-protected website, consider changing the wording to - 'Q Fever vaccination and skin testing training is undertaken via an educational video available online. Please contact the manufacturer for access details.'Chapter amended in response to commentNot applicable
34.15
Q fever
22610Dr KL Bosward, A/Prof JN Norris & A Shapiro (Faculty of Veterinary Science, University of Sydney) would like to recommend the inclusion of dog & cat breeders in the list of those at risk of infection with Q fever & who should receive vaccination. There have been 2 recent (2007 & 2010) outbreaks of
Q fever in small animal vet hospitals in Western Sydney associated with caesareans  performed on dogs & cats.  Preliminary results of seroprevalence studies of previous exposure to Coxiella burnetii in dogs & cats in the Sydney region performed by our group indicate an overall seroprevalence on IFA in cats of 6.9% (n=708) with the highest prevalence in the cattery-confined breeding cats (9.3%) compared to pet (5.1%), shelter (0%) & feral cats (4%).  Lower prevalence (total 4.8%) with a similar pattern has been obtained in preliminary dog studies.  These results are supported by several reports in the literature of outbreaks in humans overseas in association with peri-parturient dogs & cats. 
Chapter amended in response to commentNot applicable
14.16 Rabies/ Australian Bat Lyssavirus23724The row which details with Nerve Tissue Vaccines contains the advice on HRIG as follows "Administer HRIG if not already given”. However, on page 2 of the ATAGI advice it says if "NTV was administered without RIG and less than 7 days has elapsed since the first NTV was administered, RIG and the modified 4 dose Essen Schedule should be administered.
So should the advice in the Handbook for Nerve Tissue vaccines read "Administer HRIG if within 7 days of the first dose of vaccine. Do not give HRIG if 8 days or more since 1st dose of vaccine"?
Chapter amended in response to commentNot applicable 
24.16 Rabies/ Australian Bat Lyssavirus23418In PreP section on page 4 need to change text to be consistent with amended algorithms i.e. remove reference to electricity power line workers.Chapter amended in response to commentNot applicable 
34.16 Rabies/ Australian Bat Lyssavirus23533In potential ABLV exposure section on page 6 there is statement that "Where more than 12 months has elapsed since the bat bite occurred, and following assessment by a clinician consultation with public health unit staff, HRIG only may be withheld but the complete post-exposure vaccination schedule should still be completed." I think this relates back to ATAGI WP reply to CDNA which stated "For ABLV exposures the Handbook will reflect the public health practice of not administering RIG but still offering vaccinations where more than
12 months have elapsed since the exposure." However this practice was only ever in place in QLD as standard practice. We have not included this in the SoNG so suggest you delete form the Handbook
Chapter amended in response to commentNot applicable 
44.16 Rabies/ Australian Bat Lyssavirus23724The table PEP commenced overseas has two rows for each of the scenarios where 2 doses given on day 0 ie with or without RIG - I presume you are going to delete the old rows? I have attached the latest draft of the SoNG addressing/incorporating all CDNA comments/suggested changes to date. I have inserted some wording re the ID route in Section 3, which I think is consistent with the new chapter. I have also inserted sentences re our understanding re the rationale for booster doses "Booster doses are not required for anyone who has received 3 previous IM doses of rabies vaccine, whether as part of a pre-exposure or post-exposure course, if their only exposure risk is travelling to or living in a rabies endemic area. Booster doses may be required if there is an ongoing occupational (including volunteer work) exposure risk, on the basis that there may be increased likelihood of an inapparent exposure occurring." Do you think this is an accurate/aprropriate statement?  No action requiredAligns with SONG, evidence to change current recommendation being discussed
214.16 Rabies/ Australian Bat Lyssavirus23724Table 4.16.3 may have been overcomplicated on the basis of limited evidence. Where two doses of rabies vaccine have been provided overseas on day 0, the table differentiates on the basis of whether RIG has been administered. This leads to an additional dose, which complicates what would be a simpler approach of simply encouraging two further doses on day 7 and day 14.
The primary basis of this recommendation is a study by Vodopija et al (1986) of the interaction of rabies vaccine with HRIG and the reliability of the 2-1-1 schedule. Although the rabies antibody response universally achieved the indicative protective threshold with all 5 classes of rabies vaccine (with or without HRIG) by day 14, no vaccine with or without RIG achieved this in all of the small number of subjects exposed by day 7. There was an insignificant trend towards superiority in the subjects who had not received HRIG but this differed by vaccine class.
No action requiredAligns with SONG, evidence to change current recommendation being discussed
94.16 Rabies/ Australian Bat Lyssavirus2342Heading 'Risk behavior modifications' - should not come under heading 'Recommendations'  Chapter amended in response to commentNot applicable 
104.16 Rabies/ Australian Bat Lyssavirus24327The product information for Rabipur as Post-exposure treatment of individuals non-immunised or with uncertain immune status states:
One injection of Rabipur i.m. on days: 0, 3, 7, 14, 28 (5-doses schedule)
Or
One dose of Rabipur is given into the right deltoid muscle and one dose into the left deltoid muscle on day 0, and one dose is applied into the deltoid muscle on days 7 and 21 (2-1-1 regimen). In small children the vaccine is to be given into the thighs
Chapter amended in response to commentNot applicable 
224.16 Rabies/ Australian Bat Lyssavirus24327Please note the following variation from Rabipur Product Information - Post-exposure treatment of individuals non-immunised or with uncertain immune status - One injection of Rabipur i.m. on days -  0, 3, 7, 14, 28 (5-doses schedule) Or, One dose of Rabipur is given into the right deltoid muscle and one dose into the left deltoid muscle on day 0, and one dose is applied into the deltoid muscle on days 7 and 21
(2-1-1 regimen). In small children the vaccine is to be given into the thighs.'
Chapter amended in response to commentNot applicable 
234.16 Rabies/ Australian Bat Lyssavirus23121Transmission of rabies virus in unpasteurised milk is theoretically possible. Anecdotal reports exist of rabies transmission by ingestion of milk from rabid animals (e.g., from a rabid sheep to a nursing lamb), CDC. It might be worthwhile addressing this risk as similar exposures have been reported to our PHU before. No action requiredLimited evidence to support recommendation, however epidemiology text amended.
304.16 Rabies/ Australian Bat Lyssavirus23343Challenge the statement " the WHO states that booster doses are not required for persons who are travelling or living in an area of high risk and who have completed a primary course, pre or post with the current vaccines. "WHO quotes a paper by Suwansrinon et al a prospective study on 118 rabies vaccine recipients to support the fact that immunity is long term following primary vaccination (5 to 21 years). It is a relatively small study in a rabies endemic country. Due to the serious nature of rabies, instead of a blanket recommendation that booster doses are not required, we recommend to leave the assessment to the patient's doctor particularly providers trained in travel medicine with up to date travel information and alerts. Details regarding the patient's activities, area residing and duration of stay should be taken into consideration.No action requiredATAGI agreed that aligning with WHO statement is appropriate, providing clear distinction in text around booster requirements for Rabies vs ABL virus exposure.
304.16 Rabies/ Australian Bat Lyssavirus23441-42Object to the statement "However, the cost of IM rabies vaccination may be prohibitive for some travellers. In this circumstance, ID rabies vaccination, using a dose of 0.1mL may be considered. "This statement essentially encourages HCPs to administer ID in order to save their customers money (and to make more profit) - who polices whether the HCP has expertise in ID use. This also contradicts the information on pg. 233 (lines 33 to 35) that "rabies vaccines are not licensed for use via ID route. The ID route should never be used to administer rabies vaccine by practitioners who only occasionally provide travel medicine services. We recommend to omit the above sentence. Emphasise that it is the practitioner's own decision responsibility if they decide to administer ID.Chapter updated in response to commentNot applicable 
254.16 Rabies/ Australian Bat Lyssavirus23239Given the recent CID article documenting failure of some participants to seroconvert after 4 doses of rabies vaccine post-exposure, will the
4 dose regimen still be recommended instead of the 5 dose regimen? 'antibody levels
<0.5 IU/mL in 6 of 90 patients (6.7%) after 4 doses of vaccine' Unwanyiligira CID 2012:55 (15 July) p201
No action requiredATAGI decided not to change PEP recommendations since there is only one study supporting the use of a 5 dose regimen
524.17 Rotavirus24928-42Should add can be given from 6 weeks.Chapter amended in response to commentNot applicable
224.17 Rotavirus2481Suggest figure 4.17.1 includes an arrow indicating when rotavirus vaccines were introduced to explain the decline in hospitalisations. Chapter amended in response to commentNot applicable
224.17 Rotavirus2484Suggest 'Vaccine viruses replicate in the intestinal mucosa and can be shed in the stool of vaccine recipients, particularly after the 1st dose' is moved to page 249 line 9  where shedding is discussed in further detail. Chapter amended in response to commentNot applicable
224.17 Rotavirus24818-19Note references 19, 42-45 are all studies with RotaTeq not both rotavirus vaccines.Chapter amended in response to commentNot applicable
224.17 Rotavirus24830Please note the age limits set in REST (reference 33) were restricted in order to not have natural IS cases confound any potential vaccine-induced IS, rather than to minimise the risk of IS. Please see Heyse et al. Clin Trials 2008 for further detail.Chapter amended in response to commentNot applicable
224.17 Rotavirus2491Suggest 'Vaccine viruses replicate in the intestinal mucosa and can be shed in the stool of vaccine recipients, particularly after the 1st dose' from page 248 line 10-11 is inserted at the beginning of this paragraph. Chapter amended in response to commentNot applicable
224.17 Rotavirus25021In Table 4.17.1 second dose age limit for RotaTeq, consider changing '10-32 weeks' to '10-28 weeks' given it is preferable that 3 doses are given by 32 weeks. Please also see suggested text for footnote below (line 25-26).Chapter amended in response to commentNot applicable
224.17 Rotavirus25025-26Suggest 'and the upper age limit for either the 2nd or 3rd doses is immediately prior to turning 33 weeks old.' is altered to read 'and the upper age limit for the 3rd dose is immediately prior to turning 33 weeks old. For infants presenting for their 2nd dose after turning 29 weeks, a 2nd and final dose can be given, provided the upper age limit of 32 weeks (immediately prior to turning 33 weeks old) has not been reached.'Chapter amended in response to commentNot applicable
224.17 Rotavirus25311Please note the RotaTeq PI does not list 'previous history of intussusception or a congenital abnormality that may predispose to IS' as a contraindication. These are listed as precautions. Chapter amended in response to commentNot applicable
224.17 Rotavirus24914-15Please note PCV findings for RotaTeq and Rotarix vaccines differ- material from PCV 1 was found in Rotarix and PCV 2 DNA fragments were found in RotaTeq. References- Ranucci CS, et al. PDA J Pharm Sci and Tech 2011 and GSK media release.No action requiredEditorial decision that differentiation between PCV types is not required in this context
224.17 Rotavirus25020To minimise possible confusion, suggest 'be between 4 and 10 weeks' is changed to read 'not be less than 4 weeks' for consistency with Table 4.17.1 and RotaTeq Product Information.Chapter amended in response to commentNot applicable
114.17 Rotavirus25014Suggest listing the difference in the interpretation of upper age limit  of Rotarix between the Handbook and the Product Information leaflet be listed as a variation from product information.No action requiredThe handbook has defined age more comprehensively than the PI in this instance
114.17 Rotavirus25021Suggest listing the difference in the interpretation of upper age limit  of Rotarix between the Handbook and the Product Information leaflet be listed as a variation from product information.No action requiredThe handbook has defined age more comprehensively than the PI in this instance
144.17 Rotavirus  Update information on risk of vaccine related IS following discussion at ATAGI.Chapter amended in response to commentNot applicable
204.18 Rubella26428NHIG should only be used if termination for confirmed rubella would be unacceptable under any circumstances.
This unreferenced statement is not changed from the 9th edition. It was considered puzzling and unreasonable at a meeting of Queensland Public Health Medical Officers in 2010 or 2011. Below is my explanation why this is so. I submit the recommendation is poorly expressed, illogical, clinically unjustified, and unethical. (see following responses)
Poorly expressed:
I presume unacceptable means unacceptable to the mother (but it could be otherwise). On the other hand, the circumstances mentioned are entirely unclear, because they arise only when the mother becomes infected. What other circumstances may apply is a mystery. This seems to be a roundabout way of describing a mother with an absolute objection to abortion.
Chapter amended in response to commentNot applicable
204.18 Rubella26428Following my comment 1
Illogical: See premises from the text
Conclusions generated for various scenarios
If the pregnant woman were to become infected with rubella AND
1. Termination will definitely be done    -Don't use NHIG
2. Termination would be acceptable     -Don't use NHIG
3. Termination would be acceptable under some circumstances     -Don't use NHIG
4. Termination is unacceptable under any circumstances   -May use NHIG
Conclusion 1 seems reasonable, except we expect a mother to guarantee her future wishes and promise in advance to have an abortion.
Conclusion 2 means that abortion is expected of the mother in the future, so any possible benefit of NHIG to fetus should be discounted, which is questionable.
Conclusion 3 seems to mean that any benefit from NHIG should be withheld from women who are unsure if they would abort the fetus.
Conclusion 4 means that only women who are adamant they would not have an abortion may have access to RHIG.
Chapter amended in response to commentNot applicable
204.18 Rubella26428NHIG should only be used if termination for confirmed rubella would be unacceptable under any circumstances.
 Clinically unjustified:
 NHIG is neither dangerous, scarce or particularly expensive, so it is irrational to advise against using it, in mothers who might later choose not to have an abortion. This prescription unreasonably requires her to promise in advance whether not to have an abortion, and trivialises the difficulty of such decisions.
Chapter amended in response to commentNot applicable
204.18 Rubella26428NHIG should only be used if termination for confirmed rubella would be unacceptable under any circumstances
Unethical:
The recommendation could be paraphrased as Termination is a better treatment than NHIG, so rather push her to abort and only allow her the NHIG if she would never do it.
It is not the place of an Immunisation Handbook to prescribe indications for abortion, nor to propose unreasonable pressures placed on women to decide. This could be viewed as coercion.
Proposal:
1. Change the section heading to  Use of NHIG in pregnant women exposed to rubella
2. Drop the sentence about  &should only be used if&  above
3. Replace the sentence with something like  any benefit from NHIG would not materialise if a mother who became infected were later to abort the fetus.
Clearly, NHIG use in exposed, susceptible pregnant women is a difficult clinical judgement, since its possible benefits are small. But the current statement in the handbook is wrong on several counts.
Chapter amended in response to commentATAGI decision that this statement should be removed.
204.18 Rubella26424"Use of normal human immunoglobulin (NHIG) to prevent rubella"
This section heading is wrong because the first sentence in the section states that NHIG does not prevent rubella.
Change the section heading to Use of NHIG in pregnant women exposed to rubella.
Chapter amended in response to commentNot applicable
224.18 Rubella25919Please include  M-M-R-II in all relevant sections of this chapter. M-M-R-II is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no M-M-R-II used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL intends to submit a response for M-M-R-II when the measles, mumps and rubella Request for Tender is issued later this year.Chapter amended in response to commentNot applicable
224.18 Rubella26033-35Note this sentence is somewhat inconsistent with varicella and measles chapters which states 'The ATAGI also recommends that MMRV vaccine should not be used as the 1st dose of MMR-containing vaccine in young children unless discussed with the relevant state or territory public health authorities.' Consider inclusion of latter text to page 260 of the Rubella chapter for consistency. Please ensure all relevant chapters (measles, mumps, rubella and varicella) are consistent regarding this.  Chapter amended in response to commentNot applicable
224.18 Rubella26028Suggest addition of Table 4.22.1 from Chapter 4.22 (Varicella) p 288 at the end of this section to help clarify recommendations for MMR vaccination with  MMR vaccines and MMRV vaccines (once available from July 2013).DisagreeEditorial decision to only include Table 4.22.1 to chapter 4.22 Varicella, and chapter 4.9 Measles .
124.18 Rubella26118-21Huge congratulations on new Handbook, much more instructive for the busy clinician and thus I suspect will be more widely used by incidental immunisers.

 An exception that I would really value clearer direction is the advice re rubella vaccine for post-partum women. The obstetrician who has a woman with several documented doses of MMR but low antenatal levels reads this and is puzzled and not instructed. If such women should continue forever to have MMR post-partum please add some advice regarding to give regardless of how many previous doses. Also if this is the case please clarify the contrast with the statement above in line 13 "If their antibody levels remain low after a 2nd vaccination, it is unlikely that further vaccinations will improve this."

This section should be able to be opened quickly by infrequent immunisers such as midwives or obstetricians and have clear advice what to do and cover circumstances such as previous doses but low titres. 
Chapter amended in response to commentNot applicable
124.18 Rubella26118-21Advice to offer MMR post natally to post partum women with low titres in pregnancy differs from ACIP advice. See following:
HOWEVER THIS IS THE RESPONSE FROM ACIP US
QUESTION
If a woman's rubella test result shows she is "not immune" during a parental visit but she has 2 documented doses of MMR vaccine, does she need a third dose of MMR vaccine postpartum?
 ANSWER
ACIP does not routinely recommend more than 2 doses of MMR vaccine. A negative serology after 2 documented doses probably represents a false negative (i.e., antibody titer too low to detect with commercial tests). If a person is found to have a negative serology after 2 documented doses of MMR, it is best to stop testing for rubella.
ACIP's recommendations for the use of MMR vaccine can be assessed here:
Center for Disease Control Morbidity and Mortality Weekly Report May 22, 1998 / Vol. 47 / No. RR-8
Chapter amended in response to commentNot applicable
374.18 Rubella26119-21A commonly asked question by providers is how many MMRs can safely be given post partum for each and subsequent pregnancies. It would be ideal if the handbook could state " to a maximum of xxxx doses".Chapter amended in response to commentNot applicable
374.18 Rubella26034It would be better to define the age rather than state "young children".Chapter amended in response to commentNot applicable
204.18 Rubella26045"...males....as they are more likely to be non-immune to rubella"  Confusing.
This is not a biological problem with males response to vaccine, just that older males in this group were less likely to get vaccine in the past. The statement does not apply to ALL males born since 1966, ie not the younger males.
Chapter amended in response to commentNot applicable
204.18 Rubella26344Potentially dangerous after saying 'all contacts' should be immunised in this section.
Amend to "seronegative non-pregnant women of child bearing age..."
Chapter amended in response to commentNot applicable
204.18 Rubella26347"....excluded.... or at least 4 days after the onset of rash in the case to which they were exposed." Makes no sense and would not protect worker or their clients.
No, its after 4 days if the CASE gets a rash. See 9th edition.
Chapter amended in response to commentNot applicable
204.18 Rubella2641Expand this section to include nucleic acid testing which is reliable and gives much faster answers.Chapter amended in response to commentNot applicable
204.18 Rubella26428"NHIG should only be used if termination for confirmed rubella would be unacceptable under any 9 circumstances."
In addition to other logged comments this statement is made without any reference to very different risks at different gestational ages. A sweeping and unjustified statement.
Chapter amended in response to commentNot applicable
204.18 Rubella25816"Maternal rubella infection in the first 8 to 10 weeks of pregnancy results in fetal damage in up to 90% of affected 17 pregnancies and multiple defects are common" No mention of fetal death in this para and whether these figures include or exclude the deaths. Haymann gives the same figure with respect to births not pregnancies.Chapter amended in response to commentNot applicable
444.19 Tetanus26837The statement "unimmunised persons are well recorded" sounds slightly awkward.  Perhaps consider changing to "have been recorded" or something similar?Chapter amended in response to commentNot applicable
444.19 Tetanus26847Suggest a short sentence to say that the vaccine does not prevent growth of C. tetani in contaminated wounds, as per section 5.4, page 124 of New Zealand Immunisation Handbook 2011.Chapter amended in response to commentNot applicable
444.19 Tetanus27010Page 292 of 9th edition contained a sentence saying that immunity to tetanus will not be compromised before the 4 year-old booster dose, due to the serological response from the primary series in early childhood.  I think it would be worth retaining this sentence, to clarify that children of this age do have adequate protection.  Although this is explained in Table 4.19.1, I think it would be worth mentioning again, as the text on page 270 closely follows earlier text (line 52, page 268) which talks about 5 doses being required to achieve protective levels in childhood.Chapter amended in response to commentNot applicable
444.19 Tetanus27125-27Would be worth adding a sentence to the effect that antibiotic prophylaxis against tetanus is not indicated, as per the section on "Wound Management" on page 294 of 12th edition of CDC Pink Book.Chapter amended in response to commentNot applicable
444.19 Tetanus27111-18This section defines tetanus-prone wounds.  I think this paragraph would be better suited to the start of this section, as in the 9th edition of the Handbook.  It could follow the first sentence of that section (lines 48-49 of page 270)?Chapter amended in response to commentNot applicable
444.19 Tetanus27135-36The recently-updated NZ Immunisation Handbook 2011 states in the final paragraph of the Key Update section on page 121 that no increase in adverse events has been identified when tetanus and diphtheria toxoid-containing vaccines are given at 2 years apart vs. 10 years.  References are provided for this statement.  Is it worth considering a statement to this effect to supplement the "5 year rule" in the Precautions section at the bottom of page 271?  The advantage of including such a statement is that it would help clinicians clarify the risk of adverse events when discussing dT with patients when the history of vaccination is uncertain (e.g. in the ED situation).Chapter amended in response to commentNot applicable
114.19 Tetanus27014GSK note the difference between the Handbook recommendation (11-13 years) and the NIP schedule (10 to 17 years).Chapter amended in response to commentNot applicable
114.19 Tetanus27128Please note that additional contraindications are contained in the diphtheria-containing vaccines Product Information leaflets.Chapter amended in response to commentNot applicable
114.19 Tetanus27234-37Boostrix and Boostrix IPV PI also recommend a 5 year lapse since last tetanus vaccination. Suggest inclusion of this variation from the Product Information for Boostrix® and Boostrix® IPV.Chapter amended in response to commentNot applicable
44.20 Tuberculosis2741No changes.No action requiredComment did not require an action
344.20 Tuberculosis27627Please provide evidence for the change to the definition of high incidence country from 100 down to 40. This change would result in hundreds of children needing BCG for travel back to countries such as China and other Pacific nations.Chapter amended in response to commentNot applicable
434.20 Tuberculosis27524not just measles virus, but other live vaccines as well (note page 277, lines 24-25).
Suggest change to: It should be noted that live virus vaccines inhibit the response to.
Chapter amended in response to commentNot applicable
24.20 Tuberculosis27549Very minor point This line is in previous edition however I believe that advising about "adverse events which may follow the injection" should be done as part of the consent process, and not after the vaccination has been given, and parent has no ability to decline vaccination. Otherwise considerable changes to chapter noted.Chapter amended in response to commentNot applicable
284.21 Typhoid2807From reading reference 2 by Levine and Ferrecio, it would seem that cross protection occurred against paratyphoid B only, not other types. Also the cross protection was not statistically significant until pooled data was used, and even then vaccine efficacy was only 49%. Chapter amended in response to commentNot applicable 
224.21 Typhoid2823Note that laboratory personnel routinely working with S.Typhi were included under recommendations for vaccination with oral live attenuated vaccine in 9th edition of the Handbook.Chapter amended in response to commentNot applicable 
224.21 Typhoid2811Suggest to add 'It stimulates serum IgG responses, vigorous secretory intestinal IgA...'and reference to Ref 10.Chapter amended in response to commentNot applicable 
224.21 Typhoid28036Change manufacturer and distributor details to CSL Limited and Crucell Switzerland AG .Chapter amended in response to commentNot applicable 
224.21 Typhoid2801Note recently published reference Wahid et al 2012 Clin Vacc Immunol Vol 19 No 6 pp 825-34.Chapter amended in response to commentNot applicable 
414.22 Varicella2899To reduce variability in interpretations, it would be very helpful to define the terms of protection and immune' in relation to the actions required for vaccination of health care workers whose  serology results are:
a) positive (also referred to as 'detected');
b) low positive (may be indicated by a range or value);
c) equivocal (may be indicated by a range or value);
d) negative (also referred to as 'not detected')
This is similarly illustrated in table 4.15.1, page 227.
Alternatively, should we be guided by the comment/interpretation made by the laboratory that is documented on the serology report e.g. 'Equivocal: Doubtful Immunity' (cited in a hospital laboratory report).  If so, could this be clearly stated in the handbook? 
Chapter amended in response to commentText amended to reflect ATAGI decision to refer to the laboratory
74.22 Varicella2895-13Include carers, and staff of long term care facilities and home careChapter amended in response to commentNot applicable
224.22 Varicella29328-30Please include  M-M-R-II. M-M-R-II is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no
M-M-R-II used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL intends to submit a response for M-M-R-II when the measles, mumps and rubella Request for Tender is issued later this year.
Chapter amended in response to commentNot applicable
224.22 Varicella28618As the long-term data showing an increase in vaccine failure is from one study, suggest this is clarified (e.g. start this sentence with 'recent long-term data from one study have shown...')  Note recent data from a 14 year follow up study from the Kaiser Permanente which do not show an increase in vaccine failures with increasing time (note proportion of patients received
2 doses) Ref - Ray P, et al. Varicella vaccine effectiveness A long-term cohort study in the U.S. Oral presentation to Infectious Diseases Society of America 48th Annual Meeting (IDSA), Vancouver, Canada, Oct. 21-24. 2010 (abstract 3780).
Chapter amended in response to commentEditorial decision not to include conference abstracts
224.22 Varicella29120-21Please note additional reference - Jacobsen SJ, et al. Vaccine 2009.Chapter amended in response to commentNot applicable
Top of Page

10th Edition Australian Immunisation Handbook – Public Consultation Responses continued.

Submission No:  1-54Part No Page NoLine NoCommentsProposed ActionRationale
224.22 Varicella28838Typographical error - delete second full stop.Chapter amended in response to commentNot applicable
224.22 Varicella28736-38Note this sentence is somewhat inconsistent with page 293 line 33-35 which states 'The ATAGI also recommends that MMRV vaccine should not be used as the 1st dose of MMR-containing vaccine in young children unless discussed with the relevant state or territory public health authorities.' Consider inclusion of latter text to page 287 for consistency. Please ensure all relevant chapters (Measles, mumps, rubella and varicella) have a consistent message regarding this. Chapter amended in response to commentNot applicable
224.22 Varicella28716Given recommendations for two doses, suggest it would be useful to include interchangeability information. The following comparative studies may be of use - Spackova M, et al. Vaccine. 2010, Blatter MM, et al. Pediatr Infect Dis J. 2012Chapter amended in response to commentNot applicable
224.22 Varicella2879Please update '30 minutes' to '150 minutes' or '2.5 hours' in line with Varivax Product Information. Chapter amended in response to commentNot applicable
224.22 Varicella28710Suggest deletion of 'Store at 2 degrees C to 8 degrees C. Do not freeze. Protect from light.' as this is stated above for all varicella containing products on lines 2-3.Chapter amended in response to commentNot applicable
224.22 Varicella28631The diluent for Varivax is available as a pre-filled diluent syringe.Chapter amended in response to commentNot applicable
184.22 Varicella29145Where this chapter refers to "CSL Bioplasma"  in all instance, it should be "CSL Limited".Chapter amended in response to commentNot applicable
114.22 Varicella29120This paragraph does not include the PASS study data supplied to ATAGI in May 2012.  The data is currently embargoed (embargo to be lifted at the end of August) although could be considered for the Handbook given publication will be  in late 2012.No action requiredEditorial decision not to include unpublished data
14.23
Yellow fever
29918-19Recommend replacing the text in brackets with the following: (refer to the World Health Organisation's International Travel and Health Interactive maps.Chapter amended in response to commentNot applicable
24.23
Yellow fever
29937Suggest adding the following sentence to the end of the paragraph: This may include travellers who are only transiting through the country.Chapter amended in response to commentNot applicable
34.23
Yellow fever
29938-42Recommend replacing the paragraph with the following:
Travellers >1 year of age arriving in Australia within 6 days of leaving a yellow fever declared place, are required to have a valid international Certificate of Vaccination or Prophylaxis with proof of valid yellow fever vaccination (see below). Travellers who do not have a valid certificate may be provided with information on yellow fever, or required to promptly seek medical assessment if they develop relevant symptoms within 6 days of leaving the declared place.
Chapter amended in response to commentNot applicable
44.23
Yellow fever
29943-46Recommend replacing the paragraph with the following:
Yellow fever disease patterns, like other diseases, are constantly changing. Australia's list of yellow fever declared places is regularly updated, but may not always reflect the most recent vaccine recommendations. To ensure efficient processing of arriving travellers, whole countries are usually listed as declared placed, which may not reflect the level of detail provided in vaccine recommendations. Australia's list of yellow fever declared places is available on the Australian Government Department of Health and Ageing's yellow fever fact sheet at http://www.health.gov.au/yellowfever.
Chapter amended in response to commentNot applicable
54.23
Yellow fever
3004Insert at the end of the paragraph the following:
Contact details for state and territory health authorities and further information for health professionals is available on the yellow fever fact sheet.
No action requiredInformation included in chapter
64.23
Yellow fever
3007-10Recommend replacing the last two sentences of this paragraph with the following:
Travellers arriving in Australia who possess an exemption from the yellow fever vaccination may be provided with information on yellow fever or required to promptly seek medical assessment if they develop relevant symptoms.
Chapter amended in response to commentNot applicable
224.24 Zoster30348Line 52 p303 and lines 1-2 p304 outline what Zostavax is not indicated for. Suggest the indication is stated at the beginning of this section for further clarity.Chapter amended in response to commentNot applicable
224.24 Zoster30414Consider deleting 'smaller'. Please note the recent publication of a randomised, double blind, placebo controlled, multicenter study in which 22439 healthy adults aged 50-59 years received either a single dose of Zostavax or placebo. The primary objective of the Zostavax Efficacy and Safety Trial (ZEST) was to determine the efficacy of Zostavax in preventing HZ in persons aged 50-59 years, the secondary objective was to assess the overall safety and tolerability of Zostavax in these subjects. Ref - Schmader KE, et al. Clin Infect Dis. 2012.Chapter amended in response to commentNot applicable
224.24 Zoster3041Suggest the additional reference Schmader KE, et al. Clin Infect Dis. 2012 which provides detail regarding efficacy across different ages.Chapter amended in response to commentNot applicable
224.24 Zoster3071Consider also including information regarding use of vaccine in patients taking lower dose systemic steroids.The poster cited below may be of interest - A study to evaluate the safety, tolerability and immunogenicity of zoster vaccine in patients on chronic and maintenance corticosteroids. Parrino et al. AHRARHP Scientific Meeting Nov 2011.Chapter amended in response to commentNot applicable
224.24 Zoster30722-31Suggest updating to include safety data from the Zostavax Efficacy and Safety Trial (ZEST) Ref - Schmader KE, et al. Clin Infect Dis. 2012. The following postmarketing safety study may also be of interest - Tseng et al. J Intern Med 2012. Chapter amended in response to commentNot applicable
224.24 Zoster30546Please note - Interim results from a study of Zostavax (two doses) in HIV infected adults on combination antiretroviral therapy with well preserved immune function have recently been presented at the Conference on Retrovirueses and Opportunistic Infections. Ref - Benson CA et al. CROI March 2012 Abstract 96. (Note, the text of the abstract only reports on a small subset of the total study subjects).No action requiredEditorial decision not to reference conference abstracts
224.24 Zoster30530-31Please note recent publication regarding HZ recurrence Yawn et al. Mayo Clin Proc. 2011.Chapter amended in response to commentNot applicable
224.24 Zoster30521-23Please change 'In addition, efficacy of zoster vaccine has only been demonstrated in clinical trials in adults 60 years of age or greater. Small studies of the safety and immunogenicity of Zostavax in the 50-59 year age group suggest that the vaccine is likely to be safe and immunogenic (see 'Vaccine' above)'.Please note the recent publication of a randomised, double-blind, placebo controlled, multicenter study, in which 22,439 healthy adults aged 50-59 years received either a single dose of Zostavax or placebo. The primary objective of the Zostavax Efficacy and Safety Trial (ZEST) was to determine the efficacy of Zostavax in preventing HZ in persons aged 50-59 years, the secondary objective was to assess the overall safety and tolerability of Zostavax in these subjects. Ref - Schmader KE, et al. Clin Infect Dis. 2012.Chapter amended in response to commentNot applicable
224.24 Zoster30450-51p307 line 34-35 states 'The ATAGI instead recommends that Zostavax may be administered concurrently with other vaccines as indicated'. To minimise possible confusion, please review 'Simultaneous administration of Zostavax with pneumococcal polysaccharide vaccine should be avoided where possible, the 2 vaccines should be given at least 4 weeks apart'. Please update Pneumococcal Chapter 4.13 where required for consistency. Please note, The Advisory Committee on Immunization Practices (ACIP) recommend that zoster vaccine can be administered with other indicated vaccines during the same visit (e.g., Td, Tdap, and pneumococcal polysaccharide vaccines). Each vaccine must be administered using a separate syringe at a different anatomic site. Ref - Harpaz R, Ortega-Sanchez IR, Seward JF. MMWR Recomm Rep. 2008.Chapter amended in response to commentNot applicable
224.24 Zoster30437Zostavax contains calf bovine serum  - albumin is not listed as a component (Ref - Zostavax Product Information).Chapter amended in response to commentNot applicable
224.24 Zoster30431-32The sentence 'The immunogenicity of Pneumovax 23 was not affected' is relevant to the study described by lines 28-31.Please switch so that 'The immunogenicity of Pneumovax 23 was not affected.' is before 'However, an observational study from the United States suggests this may not impact on Zostavax effectiveness.'Chapter amended in response to commentNot applicable
224.24 Zoster30426Please change 'There have been no efficacy studies of Zostavax in persons less than 60 years of age'. Please note the recent publication of a randomised, double blind, placebo controlled, multicenter study, in which 22 439 healthy adults aged 50-59 years received either a single dose of Zostavax or placebo. The primary objective of the Zostavax Efficacy and Safety Trial (ZEST) was to determine the efficacy of Zostavax in preventing HZ in persons aged 50-59 years, the secondary objective was to assess the overall safety and tolerability of Zostavax in these subjects. Ref -Schmader KE, et al. Clin Infect Dis. 2012.Chapter amended in response to commentNot applicable
185.0 Passive immunisation using Immunoglobulin preparations31030Where this chapter refers to "CSL Bioplasma"  in all instance, it should be "CSL Limited".Chapter amended in response to commentNot applicable
185.0 Passive immunisation using Immunoglobulin preparations31110I would suggest replacing the wording " a large (19 or 20) gauge" to "an appropriate sized needle" to reflect the wording in the TGA approved product information(PI) for NHIG. ref: TGA PI. ref: Normal Immunoglobulin-VFChapter amended in response to commentNot applicable
185.0 Passive immunisation using Immunoglobulin preparations31320It should also be given to the fully immunised patient with a tetanus-prone wound if more than 10 years have elapsed since the last vaccine dose. This indication is in the current PI. Thus may need to be considered.Chapter amended in response to commentNot applicable
185.0 Passive immunisation using Immunoglobulin preparations31111The statement "This product should not be administered intravenously." a stronger caution has been adopted in the latest TGA approved PI where "should" is replace with "must" ie "This product must not be administered intravenously". https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-02380-3  My recommendations is that any other IM products that have the potential to be mistakenly given as IV, the same principles applies to minimise iatrogenic mistakes by administrators.Chapter amended in response to commentNot applicable
185.0 Passive immunisation using Immunoglobulin preparations31225-26".. may have some efficacy if administered out to as late as 10 26 days post exposure".
Due to the short supply of ZIG should this statement still be included. There is no indication for this scenario in the TGA PI.
DisagreeOriginal statement is appropriate as ZIG supply is dealt with separately.
185.0 Passive immunisation using Immunoglobulin preparations31318-19There may be some redundancy in this statement and might be more succinct if replaced with..."Tetanus Immunoglobulin-VF is indicated for the passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus  or whose immunisation history is doubtful". This statement is from the approved TGA PI. ref: Normal Immunoglobulin-VFNo action requiredOriginal statement maintained as it is more comprehensive than the statement in the PI.
9Appendix 1 Contact details for Australian State and Territory Government Health  Authorities and Communicable Disease Control 3171NSW Ministry of Health can now use a 1300 number which will connect automatically to PHUs:
1300 066 055
Chapter amended in response to commentNot applicable
22Appendix 3 Components of vaccines used in the National Immunisation Program3220Please include M-M-R-II as containing Gelatin. M-M-R-II is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no M-M-R-II used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL intends to submit a response for M-M-R-II when the measles, mumps and rubella Request for Tender is issued later this year. Note Mannitol is not listed as an ingredient in the ProQuad Product Information.Chapter amended in response to commentNot applicable 
22Appendix 3 Components of vaccines used in the National Immunisation Program3240Please include M-M-R-II as containing Polysorbate or sorbitol.
M-M-R-II is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no M-M-R-II used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL intends to submit a response for
M-M-R-II when the measles, mumps and rubella Request for Tender is issued later this year.
Chapter amended in response to commentNot applicable 
22Appendix 3 Components of vaccines used in the National Immunisation Program3230Please include M-M-R-II as containing Neomycin. M-M-R-II is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no M-M-R-II used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL intends to submit a response for M-M-R-II when the measles, mumps and rubella Request for Tender is issued later this year.Chapter amended in response to commentNot applicable 
22Appendix 3 Components of vaccines used in the National Immunisation Program3218Please include Liquid PedvaxHIB as containing Aluminium hydroxide and Borax. Liquid PedvaxHIB is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no Liquid PedvaxHIB used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL has recently submitted a response for Haemophilus influenzae type B vaccine (12 month cohort) Request for Tender. Chapter amended in response to commentNot applicable 
11Appendix 3 Components of vaccines used in the National Immunisation Program322 Multiple references to 'gelatin' are made in the Handbook although the type of gelatin is first referenced on this page.  Suggest defining the type of gelatin throughout the Handbook in case medical or religious contraindications existDisagreeProduct information does not consistently specify source of gelatin
9Appendix 4 Commonly asked questions about vaccination33238Query include some discussion regarding waning pertussis immunity.Chapter amended in response to commentsNot applicable
5Appendix 4 Commonly asked questions about vaccination33141-48Some Australians, would regard vaccines cultured in cell lines derived from foetuses aborted over 40 years ago to be ethically compromised. The possibility of cellular residuals is of significance to these people. In Australia vaccines considered ethically compromised could be rubella, chicken pox, zoster, hepatitis A, polio and rabies. While some information is available in the Australian Government publication "Myths and Realities," pg 13, it would be pertinent to include information in this handbook. Information could also be listed with each individual vaccine, where there is a comment regarding the cell line utilised in the culture of the vaccine. This is a growing area of concern, and to provide accurate information regarding immunisation with ethically compromised vaccines would be beneficial to the community. We have done some work on this issue and this can be found in: Brussen, KA Ethically Compromised Vaccines in Australia, Chisholm Health Ethics Bulletin, 17, 3: 2012. Chapter amended in response to commentsNot applicable
22Appendix 4 Commonly asked questions about vaccination3285Consider addition of zoster vaccine and Chapter 4.24 to this list.Chapter amended in response to commentsNot applicable
22Appendix 7 Overview of vaccine history in Australia3430Suggest inclusion of funded HPV for 12-13 year old males plus a 2 year catch up for year 9 males starting 2013.Chapter amended in response to commentNot applicable
22Appendix 7 Overview of vaccine history in Australia34302009 Pedvax vaccine ceased nationally - Liquid PedvaxHIB is currently registered in Australia and listed as a designated vaccine on the NIP. While currently there is no Liquid PedvaxHIB used in Australia, it is possible that there will in the near future. In line with the Government's National Procurement Strategy, CSL has recently submitted a response for Haemophilus influenzae type B vaccine
(12 month cohort)Request for Tender.
Chapter amended in response to commentNot applicable
26Back Inside Cover1Not applicableservice providers can photocopy this information to give to parents. throughout the table would you consider changing the word 'aerosols' to a more user friendly word.Chapter amended in response to commentsNot applicable
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Page last modified: 03 January, 2013