The Australian Immunisation Handbook 10th Edition

3.3 Groups with special vaccination requirements

Page last updated: 30 August 2016

This chapter has been amended on July 2016.

This chapter considers the use of vaccines in persons who have special vaccination requirements, persons who may experience more frequent adverse events following immunisation and persons who may have a suboptimal response to vaccination. Recommendations for vaccination of persons at occupational or lifestyle-associated risk are also included. Although recommendations are discussed under each sub-heading in this chapter, it is also important to refer to the relevant disease-specific chapters in Part 4 for further information.

Administration of certain vaccines is a priority for some persons with medical conditions that increase the risk of infectious diseases, even in the absence of specific immune defects, for example, the use of influenza and pneumococcal vaccines in individuals with an increased risk of complications from these diseases. The presence of additional recommendations specific to groups discussed in this section underpins the importance of pre-screening those attending for immunisation and being certain to regularly review the vaccination needs of those seeking medical attention for any reason.

3.3.1 Vaccination of persons who have had an adverse event following immunisation

Adverse reactions after being given a vaccine (also known as ‘vaccine side effects’) do sometimes occur. It is usually not possible to predict which individuals may have a mild or a rare, serious reaction to a vaccine. However, by following guidelines regarding when vaccines should and should not be used, the risk of adverse effects can be minimised. The term ‘adverse event following immunisation’ (AEFI) refers to any untoward medical occurrence that follows immunisation, whether expected or unexpected, and whether triggered by the vaccine or only coincidentally occurring after receipt of a vaccine dose.1 For more information on AEFI, refer to 2.3.2 Adverse events following immunisation.

Serious adverse events occur rarely after immunisation. Recognised rare and serious AEFI are described in 2.3.2 Adverse events following immunisation. Pre-vaccination screening should identify persons who have experienced an AEFI and also identify persons with conditions that are precautions and/or contraindications to vaccines (refer to Table 2.1.1 Pre-vaccination screening checklist). The relevant disease-specific chapter(s) in Part 4 of this Handbook should be consulted for each vaccine regarding contraindications and precautions that are relevant. In general, persons who have had a non-serious adverse event can be safely revaccinated by their usual immunisation service provider. Determining whether revaccination should be provided after a serious event has occurred following vaccination can be more challenging. At the individual patient level, an assessment should be made as to whether the vaccine(s) was causally related to the adverse event. This includes a thorough medical assessment, including determining the need for, or availability of, specific tests to predict whether the AEFI is likely to recur with subsequent doses. Persons who have experienced a serious adverse event following immunisation (other than a contraindication, such as anaphylaxis confirmed as triggered by a vaccine or one of its components) can usually subsequently be vaccinated under close medical supervision. However, further advice should be sought where appropriate, by referral to a specialist clinic for the management of persons with special vaccination requirements (including persons who have had a previous AEFI).

Information about specialist immunisation clinics, or the contact details for paediatricians or medical specialists with experience in management of persons with AEFI, are usually available from state and territory health authorities (refer to Appendix 1 Contact details for Australian, state and territory government health authorities and communicable disease control) and from the Immunise Australia website (www.immunise.health.gov.au).

Allergies

Vaccines rarely produce allergy or anaphylaxis (a rapid and life-threatening form of allergic reaction). Overall, the risk of anaphylaxis after a single vaccine dose has been estimated as less than 1 case per 1 million; however, this risk varies depending on the vaccine type.2 Antibiotics, gelatin and egg proteins are the components most often implicated in allergic reactions. Yeast has only rarely been associated with vaccine-related allergic reaction. Persons allergic to latex may be at risk from some vaccines. This is usually not from the vaccine formulation itself, but from the presence of latex in the equipment used to hold the vaccine, such as vaccine vial stoppers (bungs) and syringe plungers. However, very few vaccine bungs contain natural latex. Before administering the vaccine, consult the product information (PI) of each vaccine to check for the presence of latex or, where not listed on the PI, contact the vaccine manufacturer for specific details.

It is important that immunisation service providers assess each individual for a history of allergies and previous reactions to vaccines prior to giving any dose of vaccine. Depending on the allergy identified, there often may not be a contraindication to vaccination. For example, a history of allergy to antibiotics most commonly relates to β-lactam or related antibiotics and is not a contraindication to vaccines that contain other classes of antibiotics like neomycin, polymyxin B or gentamicin. Previous reactions to neomycin that only involved the skin are not considered a risk factor for a severe allergic reaction or anaphylaxis to vaccines manufactured with neomycin because there are only trace amounts of this antibiotic in the final product.3 Similarly, the measles and mumps components of measles-mumps-rubella (MMR) vaccine contain only a negligible quantity of egg ovalbumin and do not contraindicate MMR vaccination of persons with egg allergy (even anaphylaxis) (refer to ‘Vaccination of persons with a known egg allergy’ below).4-7

It is important that persons who experience an allergic reaction associated with a vaccine dose are fully investigated appropriately to ascertain the possible causal relationship to vaccination, and determine if, and under what circumstances, repeat doses of vaccine can be provided. Specialist advice should be sought where appropriate (refer above).

Vaccination of persons with a known egg allergy

Influenza vaccines

A history of anaphylaxis or a serious allergic reaction to eggs has previously been considered an absolute contraindication to influenza vaccination. However, there have now been a number of studies indicating that the majority of persons with egg allergy, including anaphylaxis, can be safely vaccinated with influenza vaccines that contain less than 1 μg of ovalbumin per dose8-10(refer to 4.7 Influenza).

The majority of vaccine-associated anaphylaxis cases reported as likely due to egg allergy occurred following administration of one of the older formulations of influenza vaccine.9 Today, due to manufacturing changes, the quantity of egg ovalbumin present in the majority of influenza vaccines used in Australia is less than 1 μg of ovalbumin per dose.8 Note that the amount of residual egg ovalbumin may vary from year to year due to manufacturing processes, vaccine batches and country of origin. The PI of the vaccine to be given should be checked for the vaccine’s ovalbumin content prior to vaccine administration.8,9,11,12

Given that there is still a small risk of anaphylaxis, it is essential that persons with a history of a serious allergic reaction to eggs are vaccinated in facilities that have staff who are able to recognise and treat anaphylaxis.8,9 Allergy testing (e.g. skin testing) with influenza vaccine prior to administration is not recommended, as there is poor correlation between test results and vaccine tolerance.8,9 Detailed information on influenza vaccination of individuals with an allergy to eggs can be found in the Australasian Society of Clinical Immunology and Allergy (ASCIA) guidelines8 (available at www.allergy.org.au/health-professionals/papers/influenza-vaccination-of-the-egg-allergic-individual).

Other vaccines

Vaccines used in Australia that contain traces of egg ovalbumin, in addition to most influenza vaccines, are:

  • rabies vaccine, Rabipur (refer to 4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus))
  • yellow fever vaccine, Stamaril (refer to 4.23 Yellow fever)
  • Q fever vaccine, Q-Vax (refer to 4.15 Q fever).

Of these vaccines, yellow fever and Q fever vaccines contain a higher amount of ovalbumin than is present in the currently available influenza vaccines and are contraindicated in persons with known severe allergy to eggs. Persons with egg allergy requiring vaccination with either yellow fever or Q fever vaccines should seek specialist immunisation advice from state or territory health authorities (refer to Appendix 1 Contact details for Australian, state and territory government health authorities and communicable disease control).

For rabies vaccination, pre- or post-exposure vaccination should be undertaken using the human diploid cell vaccine (HDCV; Mérieux Inactivated Rabies Vaccine), and not using the purified chick embryo cell vaccine (PCECV; Rabipur Inactivated Rabies Virus Vaccine) (refer to 4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus)).

Although measles and mumps (but not rubella or varicella) vaccine viruses are grown in chick embryo tissue cultures, it is now recognised that measles- and mumps-containing vaccines contain negligible amounts of egg ovalbumin and can be safely administered to persons with a known egg allergy (refer to 4.9 Measles).4-7

3.3.2 Vaccination of women who are planning pregnancy, pregnant or breastfeeding, and preterm infants

Women planning pregnancy

The need for vaccination, particularly for hepatitis B, measles, mumps, rubella and varicella, should be assessed as part of any pre-conception health check. Where previous vaccination history or infection is uncertain, relevant serological testing can be undertaken to ascertain immunity to hepatitis B, measles, mumps and rubella. Routine serological testing for varicella does not provide a reliable measure of vaccine-induced immunity, although can indicate whether previous natural infection has occurred (refer to 4.22 Varicella). Influenza vaccine is recommended for any person who wishes to be protected against influenza and is recommended for women planning pregnancy. Those with risk factors for pneumococcal disease, including smokers and Aboriginal and Torres Strait Islander women, should be assessed for pneumococcal vaccination. Women who receive live attenuated viral vaccines should be advised against falling pregnant within 28 days of vaccination.

Refer to the relevant disease-specific chapters in Part 4 for more information about vaccination requirements for these diseases.

It is also important that women of child-bearing age who present for immunisation should be questioned regarding the possibility of pregnancy as part of the routine pre-vaccination screening, to avoid inadvertent administration of a vaccine(s) not recommended in pregnancy (refer to 2.1.4 Pre-vaccination screening).

Pregnant women

Refer to Table 3.3.1 summarises the recommendations for vaccine use in pregnancy. More detailed information is also provided under the ‘Pregnancy and breastfeeding’ sections of each disease-specific chapter in Part 4 of this Handbook.

Seasonal influenza and dTpa are the only vaccines that are routinely recommended for pregnant women.

Many other inactivated vaccines are not routinely recommended during pregnancy on precautionary grounds; however, there is no convincing evidence that pregnancy should be an absolute contraindication to vaccination with these vaccines. There is some evidence that fever per se is teratogenic; however, in clinical studies most inactivated vaccines are not associated with increased rates of fever in adults (as compared with placebo).13,14 Recommendations regarding vaccine use in pregnancy are made where the benefits of protection from vaccination outweigh the risks. Eliminating the risk of exposure to vaccine-preventable diseases during pregnancy (e.g. by changing travel plans, avoiding high-risk behaviours or occupational exposures) is both an alternative and complementary strategy to vaccination.

Live attenuated viral vaccines are contraindicated in pregnant women because of the hypothetical risk of harm should vaccine virus replication occur in the fetus. If a live attenuated viral vaccine is inadvertently given to a pregnant woman, or if a woman becomes pregnant within 28 days of vaccination, she should be counselled about the potential for adverse effects, albeit extremely unlikely, to the fetus (refer also to 4.18 Rubella and 4.22 Varicella). There is, however, no indication to consider termination of a pregnancy if a live attenuated vaccine has been inadvertently given. The live attenuated yellow fever vaccine is not recommended in pregnant women; however, where travel to a yellow fever risk country is unavoidable, the risks and benefits of yellow fever vaccination, and other strategies to mitigate the risk of acquiring yellow fever, should be discussed (refer to 4.23 Yellow fever).

Inadvertent receipt of a vaccine contraindicated in pregnancy can be reported to the Therapeutic Goods Administration (TGA). For mechanisms for reporting to the TGA,refer to 2.3.2 Adverse events following immunisation. Post-marketing studies of pregnancy outcomes following vaccine administration are important to understand the safety profile of vaccines in this setting.For this reason some vaccine manufacturers also operate pregnancy registries, specific for their products, that will accept reports of vaccines administered during pregnancy; for example, the registry for VZV-containing vaccines in place in the United States from March 1995 to October 2013 (refer to 4.22 Varicella).

Table 3.3.1: Recommendations for vaccination in pregnancy (refer also to disease-specific chapters in Part 4)
Vaccines routinely recommended in pregnancy
Inactivated vaccines Recommendation Comments
Influenza vaccine Recommended for all pregnant women at any stage of pregnancy, particularly those who will be in the second or third trimester during the influenza season. There is evidence from clinical trial data and observational studies that there is no increased risk of congenital defects or adverse effects in the fetuses of women who are vaccinated against influenza in pregnancy. Influenza immunisation protects the mother, as pregnancy increases her risk of severe influenza, and also protects her newborn baby in the first few months after birth (refer to 4.7 Influenza).
Diphtheria-, tetanus-, and pertussis-containing vaccines (dTpa) dTpa recommended as a single dose during the third trimester of each pregnancy (28–32 weeks) Pertussis vaccination during the third trimester of pregnancy has been shown to be more effective in reducing the risk of infant pertussis than maternal vaccination post partum.15,16
Studies have found no evidence of an increased risk of adverse pregnancy outcomes related to pertussis vaccination during pregnancy.17-22
(Refer to 4.12 Pertussis for more details.)
Vaccines not routinely recommended in pregnancy
Inactivated bacterial vaccines Recommendation Comments
Diphtheria-tetanus vaccine (dT) Not routinely recommended
Can be given under certain circumstances, such as for management of a tetanus-prone wound
Tetanus- and diphtheria-containing vaccines have been used extensively in pregnant women, with no increased risk of congenital abnormalities in fetuses of women who were vaccinated during pregnancy.23-25
(Refer to 4.2 Diphtheria and 4.19 Tetanus for more details.)
Cholera (oral) vaccine Not routinely recommended There are limited data on the safety of oral cholera vaccine in pregnancy. 26
Haemophilus influenzae type b (Hib) vaccine Not routinely recommended
Can be given to pregnant women at increased risk of Hib disease (e.g. with asplenia)
Limited available data suggest that it is unlikely that use of Hib vaccine in pregnant women has any deleterious effects on pregnancy outcomes. 27
Meningococcal conjugate vaccines (MenCCV, Hib-MenCCV or 4vMenCV) Not routinely recommended
Can be given to pregnant women at increased risk of meningococcal disease (refer to 4.10 Meningococcal disease)
There are limited data on the safety of meningococcal conjugate vaccines in pregnancy.28 Where clinically indicated, meningococcal conjugate vaccine (MenCCV or 4vMenCV) can be given to pregnant women.29 Hib-MenCCV is not indicated for use in adolescents or adults.
Meningococcal polysaccharide vaccine (4vMenPV) Not routinely recommended
Can be given to pregnant women at increased risk of meningococcal disease (refer to 4.10 Meningococcal disease)
Limited available data suggest that it is unlikely that use of meningococcal polysaccharide vaccine in pregnant women has any deleterious effects on pregnancy outcomes.30,31 Where clinically indicated, meningococcal polysaccharide vaccine can be given to pregnant women, although 4vMenCV is preferred.29
Meningococcal B vaccine (MenBV) Not routinely recommended
Can be given to pregnant women at increased risk of meningococcal disease (refer to 4.10 Meningococcal disease)
No data are available. Vaccination during pregnancy has not been evaluated, although is unlikely to result in adverse effects.
13-valent pneumococcal conjugate vaccine (13vPCV) Not routinely recommended
Can be given to pregnant women at the highest increased risk of invasive pneumococcal disease (IPD) (e.g. with asplenia, immunocompromise, cerebrospinal fluid leak) (refer to 4.13 Pneumococcal disease).
No data are available. Vaccination during pregnancy has not been evaluated, although is unlikely to result in adverse effects.
Women of child-bearing age with known risk factors for IPD (including smokers) should ideally be vaccinated before pregnancy or as soon as practicable after delivery (refer to 4.13 Pneumococcal disease).
23-valent pneumococcal polysaccharide vaccine (23vPPV) Not routinely recommended
Can be given to pregnant women at the highest increased risk of invasive pneumococcal disease (IPD) (e.g. with asplenia, immunocompromise, cerebrospinal fluid leak) (refer to 4.13 Pneumococcal disease).
23vPPV has been administered in pregnancy in the context of clinical trials 32 with no evidence of adverse effects; however, data are limited.
Women of child-bearing age with known risk factors for IPD (including smokers) should ideally be vaccinated before pregnancy or as soon as practicable after delivery (refer to 4.13 Pneumococcal disease).
Q fever vaccine Not routinely recommended Safe use in pregnancy has not been established.
Typhoid Vi polysaccharide vaccine Not routinely recommended
Can be given to pregnant women travelling to endemic countries where water quality and sanitation is poor
No data are available. 33 Vaccination during pregnancy has not been directly evaluated, although is unlikely to result in adverse effects.
Inactivated viral vaccines Recommendation Comments
Hepatitis A vaccine Not routinely recommended
Can be given to susceptible pregnant women travelling to areas of moderate to high endemicity or those who are at increased risk of exposure through lifestyle factors, or where severe outcomes may be expected (e.g. pre-existing liver disease)
Limited data are available.
Hepatitis A vaccine should only be given to pregnant women who are non-immune and at increased risk for hepatitis A. 34
Vaccines not routinely recommended in pregnancy
Inactivated viral vaccines Recommendation Comments
Hepatitis B vaccine Not routinely recommended
Can be given to susceptible pregnant women for whom this vaccine would otherwise be recommended, for example, as post-exposure prophylaxis in a non-immune pregnant woman with a significant exposure to a HBsAg-positive source
Limited data are available.
Hepatitis B vaccine should only be given to pregnant women who are non-immune and at increased risk for hepatitis B. 35
Japanese encephalitis (JE) vaccine
(JEspect)
Not routinely recommended
Can be given to pregnant women at high risk of acquiring JE
Limited data are available.
JE infection is associated with miscarriage, and women who are at high risk of JE should be assessed for the need for vaccination. Where the risk of JE disease is high, pregnant women should be vaccinated using the inactivated vaccine, JEspect (not Imojev, which is a live attenuated vaccine). 36
Poliomyelitis vaccine (IPV) Not routinely recommended
Can be given to pregnant women at high risk of poliovirus exposure (e.g. travel to endemic countries)
Limited available data suggest that it is unlikely that use of inactivated poliomyelitis vaccine in pregnant women has any deleterious effects on pregnancy outcomes. 33
IPV should only be given to pregnant women when clearly indicated.
Rabies vaccine Can be given to pregnant women for whom this vaccine would otherwise be recommended (e.g. post-exposure prophylaxis). Limited available data suggest that it is unlikely that the use of rabies vaccine in pregnant women has any deleterious effects on pregnancy outcomes. 37-40
Pregnancy is never a contraindication to rabies vaccination in situations where there is a significant risk of exposure (related to occupation or travel), or where there has been a potential exposure to rabies virus, Australian bat lyssavirus or another bat lyssavirus. 41,42
Vaccines not recommended in pregnancy
Inactivated viral vaccines Recommendation Comments
Human papillomavirus (HPV) vaccine Not recommended Although HPV vaccination is not recommended during pregnancy, evidence from clinical trials and limited data from observational studies where HPV vaccine was inadvertently administered during pregnancy, indicate that there is no increased risk of adverse effects on the fetus. 43
In the event of pregnancy, completion of a 3-dose course of vaccination should be deferred until after delivery.
Live attenuated viral vaccines Recommendation Comments
Yellow fever vaccine Not recommended Pregnant women should be advised against going to the rural areas of yellow fever endemic areas. However, where travel to an at-risk country is unavoidable, such women should be vaccinated. 44,45 Yellow fever vaccine has been given to a large number of pregnant women with no adverse outcomes. 46
Vaccines contraindicated in pregnancy
Live attenuated bacterial vaccines Recommendation Comments
BCG vaccine Contraindicated There is only a hypothetical risk. BCG vaccine has not been shown to cause fetal damage. 47
Oral typhoid vaccine Contraindicated There are limited data available (animal studies), suggesting no increased occurrence of fetal damage with oral live attenuated vaccine. 48 Inactivated typhoid Vi polysaccharide vaccine is preferred (refer to above).
Live attenuated viral vaccines Recommendation Comments
Japanese encephalitis (JE) vaccine
(Imojev)
Contraindicated There is only a hypothetical risk. There are currently no data available regarding the use of this vaccine in pregnant or breastfeeding women.
Women of child-bearing age should avoid pregnancy for 28 days after vaccination.
Vaccines contraindicated in pregnancy
Live attenuated viral vaccines Recommendation Comments
Measles-mumps-rubella (MMR) vaccine
or
Measles-mumps-rubella-varicella (MMRV) vaccine
Contraindicated There is only a hypothetical risk. Despite concerns that live attenuated rubella vaccine virus might cause congenital abnormalities, rubella vaccine (either monovalent or as MMR) has been given to pregnant women (usually inadvertently) without harm to the fetus. 49,50 Even though rubella vaccine virus can infect the fetus, even for vaccine given in early pregnancy, there is no evidence that it causes congenital rubella syndrome in infants born to susceptible mothers. 51 Receipt of rubella vaccination during pregnancy is not an indication for termination. 50
Women of child-bearing age should avoid pregnancy for 28 days after vaccination.
It is recommended practice to test all pregnant women for immunity to rubella, and to vaccinate susceptible women as soon as possible after delivery and check their serological status post vaccination.
Rotavirus vaccine Contraindicated Rotavirus vaccines are not registered or recommended for use in adolescents or adults.
Varicella vaccine Contraindicated There is only a hypothetical risk. Congenital varicella syndrome has not been identified in women who have been inadvertently vaccinated with varicella vaccine in early pregnancy. 52
Women of child-bearing age should avoid pregnancy for 28 days after vaccination.
Zoster vaccine Contraindicated There is only a hypothetical risk. Women of child-bearing age are unlikely to be eligible for vaccination, as zoster vaccine is registered for use in persons ≥50 years of age. If women of child-bearing age have inadvertently been vaccinated, they should avoid pregnancy for 28 days after vaccination.
Immunoglobulins for use as pre- or post-exposure prophylaxis
Pooled or hyperimmune immunoglobulins Not routinely recommended
Can be used post exposure in susceptible pregnant women exposed to: measles, hepatitis A, hepatitis B, rabies, Australian bat lyssavirus, or varicella viruses, or tetanus
Limited data are available.
There is no known risk to the fetus from passive immunisation of pregnant women with immunoglobulins.
For more details, refer to Part 5 Passive immunisation and relevant disease-specific chapters in Part 4.

Contact between pregnant women and persons who have recently received live vaccines

Household contacts of pregnant women should be age-appropriately vaccinated. It is safe to administer measles-, mumps-, rubella- and varicella-containing vaccines, zoster vaccine and rotavirus vaccine to the contacts of pregnant women. There is no risk of transmission of measles, mumps or rubella vaccine viruses from vaccinated household contacts. There is an almost negligible risk of transmission of varicella-zoster vaccine virus (from persons vaccinated with varicella or zoster vaccines); however, vaccine recipients with a varicella-like rash should be advised to cover the rash if in contact with a pregnant woman. Although there is a very small possibility of transmission of the rotavirus vaccine viruses to pregnant contacts, the benefit of immunising infants to protect against rotavirus disease and, in turn, reduce the risk of rotavirus in household contacts, far outweighs any theoretical risk (refer to 4.17 Rotavirus).

Use of immunosuppressive therapy during pregnancy

Women who are receiving immunosuppressive therapy during pregnancy can be given inactivated vaccines where indicated (refer to Table 3.3.1 Recommendations for vaccination in pregnancy). (Refer also to 3.3.3 Vaccination of immunocompromised persons for more detailed information.) This includes pregnant women who have received short-term antenatal corticosteroids, for example, in the context of preterm labour.

Certain immunosuppressive medications given for management of a medical condition in a woman during pregnancy (e.g. biological disease modifying anti-rheumatic drugs [bDMARDs]) may cross the placenta and be detectable in the infant, particularly if given during the third trimester.53-55 In this setting, administration of live attenuated vaccines in the first few months of the infant’s life, particularly BCG vaccine, is not recommended.56 (Refer also to 4.20 Tuberculosis.) This is because of the risk that the infant’s immune response to vaccination may be reduced and potentially associated with increased vaccine virus/bacteria replication and related adverse effects. Although no specific time intervals are indicated, withholding BCG vaccine until the infant is 6 months of age is prudent.57 There are no data on the use of other live vaccines in infants born to women who have received immunosuppressive therapy in pregnancy. Due to the theoretical concern that a risk also applies to the administration of rotavirus vaccines, some experts recommend not giving rotavirus vaccine to infants born to mothers who received bDMARDs during pregnancy.58 Inactivated vaccines should be administered to these infants according to the recommended schedule. However, immune responses may be suboptimal. Additional inactivated vaccine doses may be required; expert advice should be sought regarding this.

Breastfeeding and vaccination

Vaccination is rarely contraindicated in breastfeeding women. The rubella vaccine virus may be secreted in human breast milk and there has been documented transmission to breastfed infants. However, where infection has occurred in an infant, the symptoms have been absent or mild.59-61 Infants born to mothers who are hepatitis B surface antigen (HBsAg)-positive can also be breastfed, provided the infant is appropriately immunised at birth. Although studies have indicated the presence of hepatitis B virus (HBV) in the breast milk of mothers with HBV infection, breastfeeding poses no additional risk of virus transmission, compared with formula feeding, in vaccinated infants.62 Administration of yellow fever vaccine to breastfeeding women should be avoided, except in situations where the risk of acquiring yellow fever is high, and/or travel cannot be avoided or postponed.63,64 While extremely rare, there have been several case reports of probable transmission of the yellow fever vaccine virus via breast milk.63,64 For most vaccines, the immune response to vaccination of infants in relationship to breastfeeding has been studied and taken into account. In general, breastfeeding does not adversely affect immunisation, and breastfeeding is not a contraindication to the administration of any vaccines recommended in infants.

Preterm infants

Preterm (premature) infants are defined as those born at <37 weeks gestational age. Prematurity, particularly extreme prematurity (<28 weeks gestational age) can place children at increased risk of vaccine-preventable diseases.65-67 However, despite their immunological immaturity, preterm infants generally respond satisfactorily to vaccines.68-70 Provided they are medically stable and there are no contraindications to vaccination, preterm infants should be vaccinated according to the recommended schedule at the usual chronological age, without correction for prematurity.71-73

Immunisation has been associated with an increased risk of apnoea in preterm infants vaccinated in hospital, particularly those still requiring complex medical care and/or with an existing history of apnoea. Although in this setting, apnoea is generally self-limiting, measures to manage this anticipated AEFI should be taken.74-76 Specifically, hospitalised preterm infants should be monitored for apnoea or bradycardia for up to 48 hours post vaccination.76,77 If there is a history of apnoea post vaccination, consideration should be given to administering future immunisations under medical supervision.78,79 Vaccination has not been associated with an increased risk of sudden infant death syndrome (SIDS).80,81

The following recommendations are specific for preterm infants. The child’s birth weight, precise gestational age and the presence of a chronic medical condition(s) need to be considered.

Pneumococcal vaccines

All preterm infants born at <28 weeks gestation are recommended to be given 4 doses of 13-valent pneumococcal conjugate vaccine, at 2, 4, 6 and 12 months of age. A single booster dose of 23-valent pneumococcal polysaccharide vaccine at 4–5 years of age is also recommended (refer to 4.13 Pneumococcal disease and Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with a medical condition(s) associated with an increased risk of IPD, presenting at age <2 years). Children who were born at <28 weeks gestation but who do not have a chronic medical condition(s) that places them at ongoing increased risk of invasive pneumococcal disease (IPD) (refer to 4.13 Pneumococcal disease, refer to List 4.13.1 Conditions associated with an increased risk of IPD in children and adults, by severity of risk), and who have received the additional pneumococcal vaccine doses to age 5 years recommended above, do not need further pneumococcal vaccine doses after age 5 years. However, all children and adults who have chronic lung disease, or certain other chronic medical conditions, whether related to preterm birth or not, should also receive additional pneumococcal vaccine doses up to and beyond the age of 5 years (refer to 4.13 Pneumococcal disease).

Hepatitis B vaccine

Low-birth-weight preterm newborn infants do not respond as well to hepatitis B-containing vaccines as full-term infants.77,82,83 Thus, for low-birth-weight infants (<2000 g) and/or infants born at <32 weeks gestation (irrespective of weight), who are born to mothers who are HBsAg-negative, it is recommended to give hepatitis B vaccine at birth, followed by 3 doses of a hepatitis B-containing vaccine, at 2, 4 and 6 months of age, with a booster dose at 12 months of age. The booster dose can be administered without measuring the antibody titre following the primary series. Alternatively, if an anti-HBs titre is measured, this should be done a minimum of 1 month after the 6-month dose, and if the anti-HBs titre is <10 mIU/mL, a booster dose should be given (refer to 4.5 Hepatitis B). Preterm infants born to HBsAg-positive mothers should be given hepatitis B vaccine and hepatitis B immunoglobulin (HBIG) after birth as specified in 4.5 Hepatitis B.

Influenza vaccine

Preterm infants have a high rate of underlying medical conditions – particularly respiratory, cardiac or neurological disease – that increase the risk of complications from influenza.84 In accordance with the recommendations for use of influenza vaccine, it is particularly important to assess preterm infants for the presence of underlying conditions that make them eligible for influenza vaccination. Vaccination should be provided annually from ≥6 months of age. Two vaccine doses, at least 4 weeks apart, are required in the first year that influenza vaccine is received (refer to 4.7 Influenza).

Rotavirus vaccine

Preterm infants, including medically stable hospitalised infants, can receive the rotavirus vaccine at chronological age without correction for prematurity. Strict upper age limits for vaccine administration apply and depend on which rotavirus vaccine is administered (refer to 4.17 Rotavirus).

Hib vaccine

If a PRP-OMP Hib vaccine is used for primary immunisation of an extremely preterm low-birth-weight infant (<28 weeks gestation and/or <1500 g birth weight), a total of 3 (not 2) primary doses of vaccine should be given. Thus, the schedule should include 4 doses of a Hib-containing vaccine (either PRP-OMP or PRP-T-containing), given at 2, 4, 6 months and a booster dose at 12 months of age (refer to 4.3 Haemophilus influenzae type b).

3.3.3 Vaccination of immunocompromised persons

A person can be immunocompromised due to disease and/or medical treatment. The extent of immunocompromise can vary from insignificant to profound, and this, together with the risk of acquiring a vaccine-preventable disease, should be taken into account when considering any vaccine. Vaccination of immunocompromised persons presents numerous challenges. For example, the extent of immunocompromise can be difficult to determine in a given individual (depending on underlying disease, medical treatment and other factors); immune protection attained from previous immunisation may be diminished; the response to vaccines administered in the setting of immunocompromise may be reduced, with additional booster vaccine doses required; the risk of vaccine-preventable diseases and/or their complications may be increased; and the risk of adverse events, particularly from live vaccines, may be increased.

When considering vaccination of persons on immunosuppressive therapy, it is particularly important to consider a number of factors, including the biologic target of the medication being used (mechanism and duration of effect on the immune system) as well as the consequence of using combination therapies (e.g. corticosteroids and other immunosuppressive therapies such as disease modifying anti-rheumatic drugs (DMARDs)), which can contribute to the nature, extent and length of immunocompromise. (Refer also to ‘Immunocompromise associated with corticosteroid administration’ and ‘Persons with autoimmune diseases and other chronic conditions’ below.) It is also important to know the anticipated duration of immunocompromise, whether due to therapy or the underlying disease. In some instances, additional booster doses of vaccines may be required to optimise protection in immunocompromised persons (e.g. pneumococcal vaccines at diagnosis of haematological malignancy). To determine the need for booster doses, it may be useful to measure post-vaccination antibody titres in selected groups in some circumstances, such as for adults or children who have received haematopoietic stem cell transplants (refer to ‘Haematopoietic stem cell transplant recipients’ below). Reliable serological testing is not readily available and/or validated to measure vaccine-induced immunity for all vaccines, and, in addition, results should be interpreted using standardised serological correlates. (Refer also to 2.1.5 Catch-up, ‘Use of serological testing to guide catch-up vaccination’.) Expert advice should be sought if required.

The recommendations in this section for the use of vaccines in immunocompromised persons have been divided where applicable into paediatric (0–18 years) and adult (≥19 years) recommendations. This distinction has been made on the basis of scientific evidence, where available, and to assist in vaccine delivery in paediatric and adult special risk settings.

Routine vaccination of immunocompromised persons

Many vaccine-preventable diseases are associated with an increased risk of morbidity and mortality in immunocompromised persons. It is particularly important to assess the vaccination history and need for additional vaccines, or further vaccine doses, for all persons who are immunocompromised or for persons who are anticipating future immunocompromise due to disease or treatment.

Two important examples of vaccines routinely recommended for immunocompromised persons are influenza and invasive pneumococcal disease (IPD). Annual influenza vaccination should be given to all immunocompromised persons ≥6 months of age (refer to 4.7 Influenza). Immunocompromised persons may also require additional doses of pneumococcal vaccines; the timing, number of doses and type of vaccine(s) vary depending on age and the underlying risk for IPD (refer to 4.13 Pneumococcal disease). These, and other specific vaccine recommendations, are discussed in more detail below.

Persons with certain specific immunocompromising conditions, haematopoietic stem cell transplant or solid organ transplant, who receive influenza vaccine for the first time are recommended to receive 2 vaccine doses, at least 4 weeks apart (irrespective of age), and 1 dose annually thereafter (refer to relevant sections below and 4.7 Influenza). Where it is known that a new influenza vaccine strain is circulating in the community to which cross-protective immunity in the population is low (such as in the setting of an influenza pandemic), it may be appropriate that immunocompromised persons receive 2 doses of inactivated influenza vaccine, a minimum of 4 weeks apart, to achieve an optimal immune response, irrespective of their previous influenza vaccination history. For example, in the 2009–2010 H1N1 global influenza pandemic it was shown that seroconversion to influenza vaccination in immunocompromised adolescents and adults was improved following receipt of 2 vaccine doses.85 Further information and annual influenza vaccine recommendations are available on the Immunise Australia website.

Household contacts of immunocompromised persons

To best protect immunocompromised persons, whether adults or children, their household and other close contacts should be fully vaccinated according to current recommendations. Annual influenza vaccination is recommended for all household contacts (≥6 months of age) of immunocompromised persons. Assessment of the need for household contacts of immunocompromised persons to receive pertussis-containing and/or varicella vaccines is also very important (refer to 4.12 Pertussis and 4.22 Varicella).86-88

The use of live attenuated viral vaccines in contacts of immunocompromised persons (MMR, MMRV, varicella and rotavirus vaccines, where indicated) is safe, and strongly recommended to reduce the likelihood of contacts infecting the immunocompromised person. Persons ≥50 years of age who are household contacts of an immunocompromised person are also recommended to receive zoster vaccine. Although there is no risk of transmission of the MMR vaccine viruses, and an almost negligible risk of transmission of varicella-zoster vaccine virus (from varicella or zoster vaccine), there is a small risk of transmission of the rotavirus vaccine virus. Hand washing and careful disposal of soiled nappies is recommended to minimise transmission.

Immunocompromised persons should avoid contact with persons with varicella and herpes zoster, where possible. (Refer also to 4.9 Measles, 4.17 Rotavirus, 4.22 Varicella and 4.24 Zoster).

Use of live viral or live bacterial vaccines in immunocompromised persons

There is a risk that the administration of live vaccines to immunocompromised persons may result in adverse events or vaccine-related disease due to unchecked infection (replication) of the vaccine virus or bacteria. This is particularly so for measles-, mumps-, rubella- 89,90 and VZV-containing (varicella and zoster) vaccines 91 and for bacille Calmette-Guérin (BCG) vaccine. 56,92 However, the risk of disease varies by vaccine and by individual. Caution is required for vaccination in the setting of immunocompromise, and in severely immunocompromised persons most live vaccines are contraindicated. If there is uncertainty around the level of immunocompromise and when vaccine administration may be safe, this should be discussed with the treating physician and expert advice should be sought.

Immunocompromised persons who have been inadvertently vaccinated with a live attenuated vaccine should be promptly assessed to establish the degree of immunocompromise and extent of risk of vaccine-associated adverse effects in order to inform appropriate management. Management may include rapid administration of immunoglobulin and/or antiviral or antibacterial therapy depending on the vaccine and clinical context. Specialist advice should be sought.

The following is a list of current recommendations for use of live vaccines in immunocompromised persons.

  • Tuberculosis vaccine (BCG) is always contraindicated.
  • Live vaccines, such as MMR- and VZV-containing (varicella and zoster) vaccines, should not be given to persons with severe immunocompromise. Severely immunocompromised persons include those who have active leukaemia or lymphoma, generalised malignancy, aplastic anaemia, graft-versus-host disease or congenital immunodeficiency. Others in this category include persons who have received recent chemotherapy, persons who have had solid organ or bone marrow transplants (within 2 years of transplantation) or transplant recipients who are still taking immunosuppressive drugs, or others on highly immunosuppressive therapy, including biological and non-biological disease modifying anti-rheumatic drugs (DMARDs) and/or high-dose corticosteroids. Dependent on their age, persons infected with human immunodeficiency virus (HIV) with CD4+ cell counts of <15%, history of an acquired immunodeficiency syndrome (AIDS)-defining illness, or clinical manifestations of symptomatic HIV are considered to have severe immunocompromise (refer also to Table 3.3.4).
  • Rotavirus, MMR and varicella vaccines, but not the combined MMRV vaccine, may be given to children and adults with HIV infection who are asymptomatic or to those persons with an age-specific CD4+ count of ≥15% (refer to ‘HIV-infected persons’ below).
  • Zoster vaccine is not recommended for adults with AIDS or symptomatic HIV infection. However, adults with asymptomatic HIV infection may be considered for vaccination on a case-by-case basis after seeking appropriate specialist advice (refer to 4.24 Zoster).
  • Zoster vaccine can be given to patients receiving certain non-biological DMARDs in low doses (i.e. methotrexate <0.4 mg/kg per week, azathioprine ≤3.0 mg/kg per day or mercaptopurine ≤1.5 mg/kg per day), either on their own or in combination with low-dose corticosteroids, after seeking appropriate specialist advice (refer to ‘Persons with autoimmune diseases and other chronic conditions’ below).
  • Immunocompetent persons who anticipate alteration of their immunity because of their existing illness can be given zoster vaccine on a case-by-case basis after seeking appropriate specialist advice (refer to 4.24 Zoster).
  • Immunocompromised travellers should not receive oral typhoid vaccines. Use inactivated parenteral typhoid Vi polysaccharide vaccine instead (refer to 4.21 Typhoid).
  • Yellow fever vaccine is generally contraindicated in immunocompromised travellers going to yellow fever endemic countries. The vaccine can, however, be considered on a case-by-case basis, including in persons with HIV (refer to 4.23 Yellow fever).

Immunocompromise associated with corticosteroid administration

The dose and duration of therapy with corticosteroids, as well as their use in combination with other immunosuppressive therapies such as DMARDs (refer to ‘Persons with autoimmune diseases and other chronic conditions’ below) determines the impact on the immune system. In cases where there is uncertainty around the level of immunocompromise and when vaccine administration may be safe, specialist advice should be sought.

In adults, daily doses of oral corticosteroids in excess of 60 mg of prednisolone (or equivalent) for more than 1 week are associated with significant immunocompromise. In children, doses in excess of either 2 mg/kg per day for more than 1 week or 1 mg/kg per day for more than 4 weeks are associated with significant immunocompromise. Live attenuated vaccines are generally contraindicated in such persons (refer also below). In addition, for both children and adults, even lower doses may be associated with some impairment of the immune response.93 It is also important, once treatment with corticosteroids is ceased, to assess whether the person has other underlying immunocompromising disease or is receiving other immunosuppressive therapy that may influence decisions about whether vaccines, particularly live vaccines, can be given.

For adults treated with systemic corticosteroids in excess of 60 mg per day for more than 1 week, live attenuated viral vaccines (such as MMR, MMRV, zoster, varicella and yellow fever vaccines) should be postponed until at least 1 month after treatment has stopped.

Children receiving >2 mg/kg per day or ≥20 mg per day in total of prednisolone (or equivalent) for more than 1 week should not receive live attenuated vaccines until after corticosteroid therapy has been discontinued for at least 1 month.

Children on daily doses of ≤2 mg/kg per day of systemic corticosteroids for less than 1 week, and those on lower doses of 1 mg/kg per day or alternate-day regimens for periods of up to 4 weeks, may be given live attenuated viral vaccines. Some experts suggest withholding lower doses of steroids 2 to 3 weeks prior to vaccination with live viral vaccines if this is possible.94,95

Pregnant women who received short-term antenatal corticosteroids, for example, in the context of preterm labour, can receive inactivated vaccine where indicated (refer to Table 3.3.1 Recommendations for vaccination in pregnancy).

Persons with autoimmune diseases and other chronic conditions

Persons with autoimmune conditions, such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and multiple sclerosis (MS), are at higher risk of infections and associated morbidity and mortality. They are also at risk of infection due to treatment with immunosuppressive agents such as corticosteroids and biological and non-biological disease modifying anti-rheumatic drugs (DMARDs).96 DMARDs encompass a range of anti-inflammatory and immunosuppressing agents. The resulting level and nature of immunocompromise depends on the specific treatment, its mechanism of action, dosage and whether use occurs in combination with other therapies, for example, corticosteroids (refer to ‘Immunocompromise associated with corticosteroid administration’ above).

When indicated, inactivated vaccines should be administered to patients with autoimmune diseases and other chronic conditions to optimise protection against the respective vaccine-preventable disease. This is despite the potential for reduced immunogenicity of vaccines in these patients due to both immunosuppressive therapies and the underlying disease.97-99 Clinical and laboratory measures of disease activity, and the choice, duration and dose of immunosuppressive therapies, do not always predict who will respond poorly to vaccination.94,100,101 In some instances, due to ongoing risk of disease, additional vaccine doses may be required, such as pneumococcal vaccine. Inactivated vaccines such as HPV, pneumococcal and dTpa can be administered to immunocompromised persons.

Every effort should be made to administer all indicated live vaccines before initiation of immunosuppressive therapy, with an interval of at least 1 month between the administration of a live vaccine and the commencement of treatment with DMARDs. Live vaccines are generally contraindicated in individuals who are already receiving DMARDs. However, the administration of live vaccines may be considered in consultation with a specialist, with careful consideration of the patient’s level of immune function and current and/or future disease risk. For example, zoster vaccine can be given to adults receiving low doses of certain non-biological DMARDs (i.e. methotrexate <0.4 mg/kg per week, azathioprine ≤3.0 mg/kg per day or mercaptopurine ≤1.5 mg/kg per day) as experts consider the level of immunocompromise associated with zoster disease to not be severe, and most individuals in the target age group are VZV-seropositive, thus reducing the risk of adverse events due to unchecked infection (replication) of the vaccine virus.102,103

In general, immunocompromised persons who are receiving DMARDs should not receive live attenuated vaccines until after therapy has been discontinued for at least 6 months; however, specialist advice should be sought on the most appropriate interval for the patient and their individual circumstances.

Live vaccines, particularly BCG, are not recommended for use in infants aged <6 months who were born to mothers who received biological DMARDs, particularly in the third trimester.56,104,105 (Refer also to 3.3.2 Vaccination of women who are planning pregnancy, pregnant or breastfeeding and preterm infants, ‘Pregnant women’, ‘Use of immunosuppressive therapy during pregnancy’ above.) Some diseases can be reactivated during therapy, so screening for infections such as hepatitis B, varicella-zoster virus and tuberculosis should be undertaken prior to vaccination.106, 107

Overall, theoretical concerns that vaccines exacerbate or cause autoimmune diseases such as rheumatoid arthritis, type 1 diabetes and multiple sclerosis have not been substantiated, with sporadic case reports not verified by larger epidemiological studies.108-111 However, persons with a history of Guillain-Barré syndrome (GBS) have an increased likelihood, in general, of developing GBS again, and the chance of them developing the syndrome following influenza vaccination may be higher than in persons with no history of GBS. A small increased risk of GBS was associated historically with one influenza vaccine in the United States in 1976, but, since then, close surveillance has shown that GBS has occurred at a very low rate of up to 1 in 1 million doses of influenza vaccine, if at all.112

Hypopituitarism is not a contraindication to vaccination if the person is only receiving physiological corticosteroid replacement, as this is not considered immunosuppressive. If the person has been unwell and is on high-dose corticosteroids for more than 1 week, the use of live attenuated vaccines should be delayed for a minimum of 1 month.

Persons with metabolic diseases should be vaccinated using the routine schedule, as vaccinations are generally considered safe in these persons.113 Influenza and pneumococcal vaccines are recommended for those with metabolic disease. Any individual concerns should be discussed with the treating metabolic physician.

Oncology patients

Paediatric and adult patients undergoing cancer chemotherapy who have not completed a primary vaccination schedule before diagnosis

Live vaccines, including BCG, MMR, zoster and varicella vaccines, are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease. These vaccines are recommended to be administered to seronegative persons at least 3 months after completion of chemotherapy, provided the underlying malignancy is in remission.114 Administration of live attenuated viral vaccines (MMR-containing or varicella-containing vaccines) should be deferred if blood products or immunoglobulins have been recently administered (refer to Table 3.3.6 Recommended intervals between either immunoglobulins or blood products and MMR, MMRV or varicella vaccination).

Influenza vaccination is recommended annually in all cancer patients aged≥6 months. Cancer patients who are immunocompromised who receive influenza vaccine for the first time are recommended to receive 2 vaccine doses at least 4 weeks apart (irrespective of age) and 1 dose annually thereafter.

Persons receiving chemotherapy may receive inactivated vaccines (e.g. 13vPCV, hepatitis B) according to a routine or catch-up vaccination schedule. The immune response may be suboptimal, but the vaccines are safe to administer.

Vaccines should not be administered during times of severe neutropenia (absolute neutrophil count <0.5 x 109/L), to avoid precipitating an acute febrile episode.

Persons with underlying haematological malignancies (such as multiple myeloma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia) are recommended to receive pneumococcal vaccination, due to the increased risk of invasive pneumococcal disease (IPD).115 Newly diagnosed children or adults who have not previously received a dose of 13vPCV are recommended to receive at least one 13vPCV dose, depending on age, and should subsequently receive 23vPPV. These vaccines should be administered as early as possible after diagnosis, according to the person’s age and previous vaccination history.116-119 Refer to 4.13 Pneumococcal disease for details.

Any deviations from these guidelines should be discussed with an oncologist.

Paediatric and adult patients with cancer who have completed cancer therapy and who completed a primary vaccination schedule before diagnosis

The majority of the following vaccines may be administered without checking antibody titres beforehand, and can be given at the same time.

The following schedule of booster vaccination is recommended if the person is well and in remission 6 months after chemotherapy:

  • single dose of DTPa-containing vaccine if <10 years of age; use either dT or reduced antigen content dTpa if ≥10 years of age
  • single dose of MMR, IPV, hepatitis B vaccines
  • single dose of 13vPCV (if previous age-appropriate dose(s) not received; refer to 4.13 Pneumococcal disease)
  • 23vPPV dose(s) (following 13vPCV, and as per 4.13 Pneumococcal disease)
  • single dose of Hib vaccine (if either <5 years of age or if ≥5 years of age with asplenia, refer to Table 3.3.5 )
  • 4vHPV vaccine: if >9 years of age, single dose if previously completed a primary course; 3-dose schedule if not previously received (schedule 0, 2 and 6 months) (refer to 4.6 Human papillomavirus)
  • varicella vaccine: persons who are seronegative to varicella-zoster virus (VZV) should receive a 2-dose schedule of varicella vaccine, at least 6 months after chemotherapy has ceased (refer to 4.22 Varicella).

Measles and rubella antibody status should be checked 6 to 8 weeks after vaccination with MMR or MMRV vaccine. Persons who have not seroconverted should receive a further dose.

Administration of live attenuated viral vaccines (MMR-containing or varicella-containing vaccines) should be deferred if blood products or immunoglobulins have been recently administered (refer to Table 3.3.6 Recommended intervals between either immunoglobulins or blood products and MMR, MMRV or varicella vaccination).

Solid organ transplant recipients

For solid organ transplant (SOT) recipients, depending on the transplanted organ, and to prevent rejection, variable doses of immunosuppressive agents are required and may influence the effectiveness of vaccines. Where possible, children undergoing solid organ transplantation should be vaccinated well before transplantation. Inactivated vaccines can be administered safely after transplantation, but are usually administered from 6 months after transplantation to maximise the immune response.120,121 Live vaccines are contraindicated in most post-transplantation protocols due to concerns of disseminated infection, although data in this population are limited.121-123 Recommended vaccinations for child and adult SOT recipients are given in Table 3.3.2.

Table 3.3.2: Recommendations for vaccinations for solid organ transplant (SOT) recipients122,124<
Vaccine Vaccines recommended before transplantation Vaccines recommended after transplantation, if not given beforehand Comment
Child
(0–18 years)
Adult
(≥19 years)
Child
(0–18 years)
Adult
(≥19 years)
Streptococcus pneumoniae (pneumococcal disease)
13-valent pneumococcal conjugate vaccine
(13vPCV)
Yes (aged
≥6 weeks)
Yes Yes (aged
≥6 weeks)
Yes Recommendations depend on age. Refer to 4.13 Pneumococcal disease and Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with a medical condition(s) associated with an increased risk of IPD, presenting at age <2 years.
23-valent pneumococcal polysaccharide vaccine
(23vPPV)
Yes (≥8 weeks after 13vPCV) Yes (≥8 weeks after 13vPCV) Yes (≥8 weeks after 13vPCV) Yes (≥8 weeks after 13vPCV) Recommendations depend on age. Refer to 4.13 Pneumococcal disease and Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with a medical condition(s) associated with an increased risk of IPD, presenting at age <2 years.
Haemophilus influenzae type b
Hib vaccine Yes Not indicated Yes Not indicated If possible, complete vaccination before transplantation.
Diphtheria, tetanus, pertussis
DTPa-containing vaccine for children <10 years of age
dTpa for those
≥10 years of age
Yes Yes, provided dTpa has not been given in
the last 10 years
Yes, if not previously vaccinated Yes, provided dTpa has not
been given in the last 10 years
The primary schedule should be completed before transplantation.
For recipients <10 years of age, not previously vaccinated, give all 3 doses as DTPa-containing vaccine.
For recipients ≥10 years of age, not previously vaccinated, give the 1st dose as dTpa, followed by
2 doses of dT. If dT is unavailable, complete vaccination course with dTpa.
Refer also to catch-up tables for children and adults in refer to 2.1.5 Catch-up.
Influenza
Influenza vaccine Annual vaccination starting before transplantation for those ≥6 months of age. Two doses of influenza vaccine at least 4 weeks apart are recommended for all SOT recipients receiving influenza vaccine for the first time post transplant (irrespective of age). Influenza vaccine should be given annually thereafter.
Poliomyelitis
IPV Yes Yes (refer to comments) Yes Yes (refer to comments) Adults who have received a routine course of polio vaccination in childhood are recommended to receive a booster every 10 years if they plan to travel to a polio endemic area or have an occupational risk of polio exposure (e.g. laboratory workers).
Hepatitis B
Hepatitis B vaccine Yes Yes, depending on serological status Yes Yes, depending on serological status Recommended for all seronegative SOT candidates. Immunogenicity is likely to be improved when vaccination is administered before transplantation.
Accelerated schedules can be used (refer to Table 4.5.2 Accelerated hepatitis B vaccination schedules (for persons with imminent risk of exposure)).
Hepatitis A
Hepatitis A vaccine* Yes, if seronegative (refer to comments) Yes, if seronegative (refer to comments) Yes, if seronegative (refer to comments) Yes, if seronegative (refer to comments) Recommended for all liver SOT recipients, or transplant candidates or recipients with chronic liver disease, or those chronically infected with either hepatitis B or hepatitis C.
Neisseria meningitidis (meningococcal disease)
Meningococcal C conjugate vaccine (MenCCV or Hib-MenCCV) Yes Not indicated Yes Not indicated A single dose of meningococcal C conjugate vaccine is recommended at 12 months of age.
4vMenCV is recommended for persons with certain medical conditions or treatments that increase their risk of IMD (refer below).
Quadrivalent meningococcal conjugate vaccine (4vMenCV)* Yes, if ≥2 months of age with defined risk factors (refer to comments) Yes, if defined risk factors (refer to comments) Yes, if ≥2 months of age with defined risk factors (refer to comments) Yes, if defined risk factors (refer to comments) 4vMenCV is recommended for persons with certain medical conditions or treatments that increase their risk of IMD (refer to 4.10 Meningococcal disease, List 4.10.1). The vaccine brand and doses required depend on the age at which the vaccine course is commenced (refer to 4.10 Meningococcal disease, Table 4.10.2).
Meningococcal B vaccine (MenBV) Yes, if at risk due to age or other defined risk factors (refer to comments) Yes, if defined risk factors (refer to comments) Yes, if at risk due to age or other defined risk factors (refer to comments) Yes, if defined risk factors (refer to comments) MenBV is recommended for certain age groups and individuals with specific risk factors placing them at increased risk of IMD (refer to 4.10 Meningococcal disease). The number of doses varies with age as outlined in Table 4.10.1 in 4.10 Meningococcal disease.
Human papillomavirus
HPV vaccine Yes Yes Yes, if no history of prior immunisation Yes, if no history of prior immunisation 3-dose schedule of 4vHPV is recommended for those aged >9 years. The routine schedule is 1st dose on day 0 (day of vaccination), 2 months, and 6 months (after 1st dose). Recommended in both females and males. For more detail, refer to 4.6 Human papillomavirus.
Measles, mumps and rubella
MMR vaccine Yes Yes, unless 2 previous documented doses Contraindicated Contraindicated The primary schedule should be completed before transplantation provided the transplant candidate is taking no immunosuppressive therapy and has no underlying cellular immunodeficiency.
Varicella
Varicella vaccine Yes, if non-immune (refer to comments) Yes, if non-immune (refer to comments) Contraindicated Contraindicated Confirm immunity with reliable history of varicella disease and confident clinical diagnosis or serological testing.
The primary vaccination schedule should be completed before transplantation, provided the transplant candidate is taking no immunosuppressive therapy and has no underlying cellular immunodeficiency.

* Any transplant recipient who anticipates travelling may require additional vaccination, such as for hepatitis A and meningococcal disease (refer also to 3.2 Vaccination for international travel).

Haematopoietic stem cell transplant recipients125,126

Haematopoietic stem cells are sourced from peripheral blood, bone marrow or umbilical cord blood. Protective immunity to vaccine-preventable diseases is partially or completely lost following either allogeneic or autologous stem cell transplantation. Immunocompromise following allogeneic transplantation is caused by a combination of the preparative chemotherapy given before transplantation, graft-versus-host disease (GVHD), and immunosuppressive therapy following transplantation. Persisting immunocompromise is common, particularly in persons with chronic GVHD. Immunity is also impaired in autologous HSCT recipients due to high-dose chemotherapy and radiotherapy, but GVHD is not a concern as donor stem cells are derived from the transplant recipient. In most cases, autologous HSCT recipients will recover their immunity more quickly than allogeneic transplant recipients.

Separate vaccination schedules for autologous or allogeneic HSCT recipients have not been supported in published guidelines because of limited data. For practical purposes, the same schedule is recommended for these two groups, regardless of donor source (peripheral blood, bone marrow or umbilical cord), preparative chemotherapy (ablative or reduced intensity), or transplant type (allogeneic or autologous).127,110

Live vaccines should by delayed until 24 months after cessation of HSCT, providing the individual does not have ongoing immunosuppression (refer to Table 3.3.3 Recommendations for revaccination following haematopoietic stem cell transplant (HSCT) in children and adults, irrespective of previous immunisation history). HSCT recipients with ongoing GVHD or remaining on immunosuppressive therapy should not be given live vaccines. Chronic GVHD (cGVHD) is associated with functional hyposplenism and therefore increases susceptibility to infections with encapsulated organisms, especially Streptococcus pneumoniae. For persons with cGVHD who remain on active immunosuppression, antibiotic prophylaxis is recommended.125

The immune response to inactivated vaccinations is usually poor during the first 6 monthsafter HSCT. Donor immunisation with hepatitis B, tetanus, Hib and pneumococcal conjugate vaccines before stem cell harvesting has been shown to elicit improved early antibody responses in HSCT recipients vaccinated in the post-transplantation period.129-132 However, practical and ethical considerations currently limit the use of donor immunisation.

Routine serological testing for several infectious agents and antibody levels conferring protective immunity are poorly defined. For those vaccines that are recommended for all HSCT recipients (tetanus, diphtheria, poliomyelitis, influenza, pneumococcal, Hib), pre-vaccination testing is not recommended as the response to a primary course of these vaccines is generally adequate. The serological response to pneumococcal vaccine is less predictable. Pneumococcal serology is only available in a few specialised laboratories and is not routinely recommended. Serology before and approximately 4 to 6 weeks after vaccination with the final dose of a hepatitis B vaccine course, and after MMR vaccine, is recommended as antibody levels will determine the need for revaccination.128 Post-vaccination varicella serology using commercial assays is very insensitive for vaccine-induced immunity (as compared with natural infection) and is not recommended (refer to 4.22 Varicella).

A recommended schedule of vaccination is outlined in Table 3.3.3.

Table 3.3.3: Recommendations for revaccination following haematopoietic stem cell transplant (HSCT) in children and adults, irrespective of previous immunisation history125,>126,>133-137"
Vaccine Months after HSCT Comments
6 8 12 24
Streptococcus pneumoniae (pneumococcal disease)
13-valent pneumococcal conjugate vaccine
(13vPCV)
Yes Yes Yes Not needed Refer to 4.13 Pneumococcal disease
23-valent pneumococcal polysaccharide vaccine
(23vPPV)
No No No Yes (after 13vPCV) Refer to 4.13 Pneumococcal disease
Haemophilus influenzae type b
Hib Yes Yes Yes Not needed
Diphtheria, tetanus, pertussis
DTPa-containing vaccine for children
<10 years of age
dTpa for those ≥10 years of age
Yes Yes Yes Not needed For recipients <10 years of age, give all 3 doses as DTPa-containing vaccine.
For recipients ≥10 years of age, give the 1st dose as dTpa, followed by 2 doses of dT. If dT is unavailable, complete vaccination course with dTpa.
Poliomyelitis
IPV Yes Yes Yes Not needed A 3-dose course of inactivated poliomyelitis vaccine is recommended. This can be given as DTPa-IPV or dTpa-IPV; refer to ‘Diphtheria, tetanus, pertussis’ above.
Hepatitis B
Hepatitis B vaccine Yes Yes Yes Not needed A high-dose formulation (H-B-Vax II dialysis formulation) is preferred. Alternatively, give single strength Hep B vaccine in each arm at each dosing interval OR administer a standard vaccination course, then check HBsAb titres 4–8 weeks following the last vaccine dose. If titres are <10 mIU/mL, repeat the vaccination course.
Influenza
Two doses of influenza vaccine at least 4 weeks apart are recommended for all HSCT recipients receiving influenza vaccine for the first time (irrespective of age), with the 1st dose given as early as 6 months after transplant (refer also to the introduction of 3.3.3 Vaccination of immunocompromised persons above), then a single dose annually thereafter.
Neisseria meningitidis (meningococcal disease)
Meningococcal B vaccine (MenBV) Yes Yes Not needed (refer to comments) Not needed (refer to comments) Two doses of MenBV are recommended for persons ≥6 months of age. Additional doses are required if the vaccine course was commenced before 6 months of age (refer to 4.10 Meningococcal disease, Table 4.10.1).
The co-administration of MenBV and 4vMenCV in persons who are at increased risk of meningococcal disease is acceptable based on first principles. (Refer also to 4.10 Meningococcal disease.)
Quadrivalent meningococcal conjugate vaccine (4vMenCV)* Yes Yes Not needed (refer to comments) Not needed (refer to comments) Two doses of 4vMenCV are recommended for persons ≥6 months of age. Additional doses are required if the vaccine course was commenced before 6 months of age (refer to 4.10 Meningococcal disease, Table 4.10.2).
The co-administration of MenBV and 4vMenCV in persons who are at increased risk of meningococcal disease is acceptable based on first principles. (Refer also to 4.10 Meningococcal disease.)
Human papillomavirus
HPV vaccine A 3-dose course of 4vHPV is recommended at intervals of 0, 2 and 6 months. Specific immunogenicity data in this group are not available; better immune responses may be expected at >12 months post transplantation when a greater level of immune reconstitution has been achieved. Individual recommendations for HPV vaccination in those >9 years of age should be determined by an individual risk assessment (refer to 4.6 Human papillomavirus).
Measles, mumps and rubella
MMR vaccine No No No Yes, 1 or 2 doses separated by a minimum interval of
4 weeks (refer to comments)
Give only if the person is off immunosuppressive therapy, with no cGVHD and with reconstituted cell-mediated immunity. Check serology 4 weeks after 1st vaccine dose. If there is no seroconversion, repeat the dose.
Varicella
Varicella vaccine No No No Yes, 2 doses separated by a minimum interval of
4 weeks (refer to comments)
Give to a seronegative recipient only if the person is off immunosuppressive therapy, with no cGVHD and with reconstituted cell-mediated immunity.

* Any transplant recipient who anticipates travelling may require additional vaccination, such as for meningococcal and hepatitis A disease (refer also to 3.2 Vaccination for international travel).
† The recommended interval between doses is 12 weeks for children who commenced their 4vMenCV course between 7 and 23 months of age as outlined in Table 4.10.2 in 4.10 Meningococcal disease.

HIV-infected persons138

Vaccination schedules for HIV-infected persons should be determined by the person’s age, degree of immunocompromise (CD4+ count) and the risk of infection (refer to Table 3.3.4 below). Children with perinatally acquired HIV differ substantially from adults, as immunisation and first exposure to vaccine antigens occurs after HIV infection, whereas in adults, most vaccines are inducing a secondary ‘boosted’ immune response. HIV-infected persons of any age whose disease is well controlled on combination antiretroviral therapy (undetected or low viral load with good preservation of CD4+ lymphocyte count) are likely to respond satisfactorily to vaccines.

Table 3.3.4: Categories of immunocompromise in HIV-infected persons, based on age-specific CD4 counts and percentage of total lymphocytes139"
Age
<12 months 1–5 years ≥6 years
Category CD4 +
per µL
% CD4 +
per µL
% CD4 +
per µL
%
No evidence of immunocompromise ≥1500 ≥25 ≥1000 ≥25 ≥500 ≥25
Moderate immunocompromise 750–1499 15–24 500–999 15–24 200–499 15–24
Severe immunocompromise <750 <15 <500 <15 <200 <15

HIV-infected persons should be vaccinated as described below.

Live attenuated vaccines

  • Rotavirus vaccines appear to be safe and immunogenic in HIV-infected but clinically stable children,140,141 although data on their use are limited. Vaccination can be given according to the routine schedule unless there is severe immunocompromise. (Refer also to 4.17 Rotavirus.)
  • MMR vaccine should be routinely administered to HIV-infected children in a 2-dose schedule at 12 months and 18 months of age unless the child has a CD4+ count of <750 per µL.142-144 The serologic response is likely to be greatly improved after the 2nd dose of MMR vaccine in HIV-infected children,145,146 so consideration should be given to administering the 2nd dose soon after the 1st dose (minimum interval between doses of 4 weeks) to increase the likelihood of a serologic response to all three components. This is particularly important if the child is travelling overseas or during episodes of local measles virus transmission. Likewise, asymptomatic HIV-infected adults with a CD4+ count ≥200 per µL who are seronegative to any of the vaccine components should receive 1 or 2 doses of MMR vaccine, depending on the number of vaccines received previously and evidence for seroconversion. Administration of MMR vaccine does not have a significant effect on the CD4+ count or viral load of HIV-infected adults.147 Measles may cause severe disease in HIV-infected children, particularly those with a CD4+ count of <750 per µL, in whom protection from vaccination may be reduced; therefore, normal human immunoglobulin (NHIG) should be given as post-exposure prophylaxis, regardless of vaccination status (refer to 4.9 Measles, and Part 5 Passive immunisation).148 The combination MMRV vaccine is not recommended for use in HIV-infected persons, due to a lack of data on its use. (Refer also to varicella text below.)
  • Varicella vaccine may be given to HIV-infected adults or children ≥12 months of age who are asymptomatic, although data on efficacy and safety in HIV-infected persons is limited.149-151 Use of the monovalent varicella vaccine (VV), given in 2 doses, at least 3 months apart, in children ≥12 months of age with age-specific CD4+ count of ≥15% is recommended.152,153 The same 2-dose VV strategy can be considered for HIV-infected adults who are varicella-seronegative and who have a CD4+ count of ≥200 per µL.152 The combination MMRV vaccine is not recommended for use in HIV-infected persons. (Refer also to 4.22 Varicella.)
  • Zoster vaccine is not recommended for adults with AIDS or symptomatic HIV infection. However, persons with asymptomatic HIV infection may be considered for vaccination on a case-by-case basis after seeking appropriate specialist advice. Serological confirmation of previous VZV infection is recommended prior to vaccination. Zoster vaccine is only registered for use in adults ≥50 years of age. (Refer also to 4.24 Zoster.)
  • Yellow fever vaccine can be administered to HIV-infected persons who are not immunocompromised (i.e. with CD4+ counts >200 per µL ) if they are at risk of yellow fever virus infection; however, vaccination of individuals with evidence of immunocompromise where risk of yellow fever virus exposure is unavoidable should be considered on a case-by-case basis with the person’s treating clinician.154 (Refer also to 4.23 Yellow fever and 3.2 Vaccination for international travel.)
  • BCG vaccine should not be given to HIV-infected children or adults because of the risk of disseminated BCG infection.155,156 (Refer also to 4.20 Tuberculosis.)
  • Oral live attenuated typhoid vaccines should be avoided in HIV-infected persons. Parenteral Vi polysaccharide typhoid vaccine should be used instead (refer to 4.21 Typhoid).

Inactivated (non-live) vaccines

  • Diphtheria-tetanus-pertussis (DTPa/dTpa), Hib and IPV vaccines can be given according to routine recommendations138,157 (refer to relevant disease-specific chapters in Part 4).
  • The 4vHPV vaccine can be given to children (≥9 years of age) and adults with HIV. It was safe and immunogenic in a small study of HIV1-infected men.158 HIV-infected persons should receive the routine course of 3 doses of 4vHPV vaccine at times 0, 2 and 6 months. Vaccination is recommended for persons in the age ranges for which the vaccine is registered (females aged 9–45 years and males 9–26 years); use of HPV vaccine in males up to the age of 45 years is unlikely to be associated with immunogenicity or adverse events that differ from those observed in females. However, the benefit of HPV vaccination is optimal when delivered to children or young adolescents prior to sexual debut (refer to 4.6 Human papillomavirus).
  • Pneumococcal disease, both respiratory and invasive (IPD), is a frequent cause of morbidity in HIV-infected children and adults (refer to List 4.13.1 in 4.13 Pneumococcal disease).159 Children should be vaccinated initially with pneumococcal conjugate vaccine (13vPCV); the number of doses depends on age at diagnosis and vaccination history (refer to Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with a medical condition(s) associated with an increased risk of IPD, presenting at age <2 years). For children aged >5 years and adults, a single dose of 13vPCV is recommended, followed by 23vPPV; repeat doses of 23vPPV are also indicated. refer to 4.13 Pneumococcal disease for details.
  • Annual influenza vaccination is recommended in all HIV-infected adults and children (≥6 months of age). In all HIV-infected children <9 years of age, 2 doses, administered a minimum of 4 weeks apart, are recommended the first time influenza vaccine is given. HIV viral load may increase after influenza vaccination, but CD4+ counts are unaffected and the benefits exceed the risk.160-163 (Refer also to 4.7 Influenza.)
  • Hepatitis B is safe to use in HIV-infected persons, but the immunological response may be diminished. Serological testing for evidence of previous hepatitis B infection should be undertaken prior to commencing vaccination. Limited studies in HIV1-positive adults have demonstrated an improved and accelerated serological response to a vaccination schedule that consists of 4 double doses, comprising two injections of the standard adult dose (using Engerix-B) on each occasion, at times 0, 1, 2 and 6 months.164,165 HIV-positive children should receive 3 doses of hepatitis B vaccine using an adult formulation (i.e. double the standard recommended dose for children).152,153 Antibody level should be measured at the completion of the vaccination schedule; if the anti-HBs titre is <10 mIU/mL, further doses are required (refer to 4.5 Hepatitis B).
  • Hepatitis A vaccines are immunogenic in most HIV-infected children,166 but are only recommended for use in non-immune HIV-infected persons if they have independent risk factors for acquisition of hepatitis A (refer to 4.4 Hepatitis A).
  • Parenteral Vi polysaccharide typhoid, inactivated Japanese encephalitis and rabies vaccines are safe and can be used in HIV-infected persons, if indicated. (refer to relevant disease-specific chapters in Part 4.)
  • 4vMenCV and MenBV are recommended (refer to 4.10 Meningococcal disease). A diminished immune response following a single dose of 4vMenCV has been reported in HIV-infected persons;167-169 however, this improves for some serogroups following a 2nd dose.168-171 There is no clinical data on the use of MenBV in HIV-infected persons; however, vaccination is recommended based on the expected benefit in these individuals.

Persons with functional or anatomical asplenia

Persons with an absent or dysfunctional spleen are at a life-long increased risk of fulminant bacterial infection, most notably invasive pneumococcal disease (IPD).115,172 Pneumococcal, meningococcal, Hib and influenza vaccination are particularly recommended for all persons with asplenia, whether functional or anatomical (such as splenectomy). Other vaccinations should be up to date. Vaccines should be provided according to the person’s age and previous immunisation history, and immunisation status should be reviewed regularly.173 Specific vaccine recommendations for persons with asplenia are discussed below and shown in Table 3.3.5.

In persons undergoing an elective splenectomy, vaccination should be completed, where possible, 2 weeks before the scheduled operation date. In an unplanned splenectomy, vaccination should commence approximately 1 week after the splenectomy has occurred.174

Children with splenic dysfunction should also be given antibiotic prophylaxis to prevent bacterial infection, until at least 5 years of age.175,176 All asplenic persons and/or their parents/carers should also be educated about the importance of early investigation and treatment of febrile illnesses, including the use of emergency antibiotics. Asplenic persons are recommended to wear a medical alert. Vaccination cannot provide protection against all bacterial infections, or even all pneumococcal serotypes that cause IPD, hence it is particularly important that persons with asplenia are informed of the life-long increased risk of severe bacterial infection, even if they have been appropriately vaccinated.

Pneumococcal vaccination

Additional doses of pneumococcal vaccine are recommended for persons with asplenia, depending on their age and previous immunisation history, as shown in Table 3.3.5. Detailed information is provided in 4.13 Pneumococcal disease and in Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with a medical condition(s) associated with an increased risk of IPD, presenting at age <2 years in 2.1.5 Catch-up.

A single dose of 13vPCV is recommended for asplenic older children and adults who have not previously received any previous 13vPCV dose.177 This should precede 23vPPV doses when possible. However, if 1 or more doses of 23vPPV have previously been given, 13vPCV should be given at the next available opportunity, and at least 1 year after the last 23vPPV dose. Subsequent doses of 23vPPV are recommended, with a maximum of 3 doses in adulthood (age ≥18 years). Age-specific recommendations are discussed in 4.13 Pneumococcal disease.

Meningococcal vaccination

4vMenCV is recommended from 2 months of age for persons with asplenia. The vaccine brand and doses required depend on the age at which the vaccine course is commenced (refer to Table 4.10.1 in 4.10 Meningococcal disease).

MenBV is recommended from 2 months of age for persons with asplenia. The number of doses depends on the age at which the vaccine course is commenced (refer to Table 4.10.1 in 4.10 Meningococcal disease).

Hib vaccination

A single dose of Hib vaccine is recommended for asplenic persons who were not vaccinated in infancy or who are incompletely vaccinated (refer to 4.3 Haemophilus influenzae type b and Table 2.1.8 Catch-up schedule for Hib vaccination for children <5 years of age in 2.1.5 Catch-up). Subsequent booster doses of Hib vaccine are not required. Persons who have received all scheduled doses of Hib vaccine do not require a booster dose before or after splenectomy.178

Influenza vaccination

Annual influenza vaccine is recommended in all persons from ≥6 months of age (refer to 4.7 Influenza), particularly those who are immunocompromised. Influenza infection can be complicated by secondary bacterial infections, such as IPD. The influenza vaccine dose is dependent on previous influenza vaccination history and age. (Refer also to Table 4.7.1 Recommended doses of influenza vaccine in 4.7 Influenza).

Table 3.3.5: Recommendations for vaccination in persons with functional or anatomical asplenia"
Age Recommendations
Pneumococcal vaccines
6 weeks to <2 years Give a 3-dose primary course of 13vPCV, with an additional dose of 13vPCV at age ≥12 months.
Refer to Table 4.13.1 and Table 2.1.11 for catch-up schedules.
2 to 5 years If the primary course of PCV is incomplete or if the recommended 13vPCV dose at age ≥12 months was not received, give 1 or 2 doses of 13vPCV as per Table 4.13.2
Give a single dose of 23vPPV at age 4–5 years.*
5 to <18 years >5 to <18 years If a 13vPCVdose has not previously been given, give a single dose of 13vPCV, preferably prior to 23vPPV.*
If a dose of 23vPPV was received at age 4–5 years, give another dose of 23vPPV 5 years later (at age 9–10 years).
If asplenia is newly diagnosed, give 2 doses of 23vPPV,
5 years apart (after 13vPCV; refer to above).
≥18 years If a 13vPCV dose has not previously been given, give a single dose of 13vPCV, preferably prior to 23vPPV.*
There is a maximum limit of 3 doses of 23vPPV during adulthood (age ≥18 years). Give the 1st adult dose at diagnosis (after 13vPCV: refer to above), or at least 5 years after the last 23vPPV dose, whichever is later.
Meningococcal vaccines
≥2 months 4vMenCV is recommended according to the age at which the vaccine course commenced (refer to 4.10 Meningococcal disease, Table 4.10.2).
MenBV is recommended according to the age at which the vaccine course commenced (refer to 4.10 Meningococcal disease, Table 4.10.1).
Haemophilus influenzae type b (Hib) vaccine
6 weeks–<5 years Give the recommended course of Hib-containing vaccine, or catch-up vaccination, according to Table 2.1.8 Catch-up schedule for Hib vaccination for children <5 years of age.
Additional/repeat doses are not required.
≥5 years If a Hib vaccine dose has not previously been given, or if the primary course of Hib vaccine is incomplete, give a single dose of Hib-containing vaccine.
If Hib vaccination is complete (as per children <5 years above), additional/repeat doses are not required.
Influenza vaccine
6 months–<3 years Give 2 doses (0.25 mL each), 4 weeks apart, in the first year of vaccination.
Give 1 dose (0.25 mL) in subsequent years.
3–<9 years Give 2 doses (0.5 mL each), 4 weeks apart, in the first year of vaccination.
Give 1 dose (0.5 mL) in subsequent years.
≥9 years Give 1 dose (0.5 mL) every year.§

* Whenever possible, 13vPCV dose(s) should precede the recommended 23vPPV dose(s). If 13vPCV follows 23vPPV, a minimum interval of 12 months between 13vPCV and the last previous 23vPPV dose is recommended. The recommended minimum interval between a 13vPCV dose and a subsequent 23vPPV dose is 2 months. Also note that the recommended minimum interval between any two 23vPPV doses is 5 years.
† If asplenia is diagnosed at age ≥65 years (age ≥50 years for Indigenous adults), only a single revaccination dose of 23vPPV is recommended.
‡ MenBV can be given from 6 weeks of age to align with the schedule for other routine infant vaccines. The co-administration of MenBV and 4vMenCV in persons who are at increased risk of meningococcal disease is acceptable based on first principles. (Refer also to 4.10 Meningococcal disease.)
§ Two doses of influenza vaccine in the first year influenza vaccine is given are required if the asplenic person has another underlying immunocompromising condition such as post SOT or HSCT.

3.3.4 Vaccination of recent recipients of normal human immunoglobulin and other blood products

The immune response to live parenteral viral vaccines (with the exception of yellow fever and zoster vaccine) may be inhibited by normal human immunoglobulin (NHIG). The interval recommended is dependent on the type and half-life of the immunoglobulin administered (refer to Table 3.3.6 Recommended intervals between either immunoglobulins or blood products and MMR, MMRV or varicella vaccination and 4.8 Japanese encephalitis).

Rotavirus vaccine may be administered at any time before or after, or concurrently with, any blood product, including antibody-containing products, following the routinely recommended schedule for rotavirus vaccine among infants who are eligible for vaccination (refer to 4.17 Rotavirus). Minimal data are available on the impact of blood products on the immune response to the vaccine in these infants. Completing the full rotavirus vaccine series will optimise protection.179

Zoster vaccine can be given at any time before or after administration of immunoglobulin, or any antibody-containing blood product, because those for whom it is registered (persons ≥50 years of age) are assumed to have had a previous VZV infection and, therefore, already have serum antibody levels comparable to those found in blood products (refer to 4.24 Zoster).

BCG vaccine can be given at any time before or after administration of immunoglobulin or any antibody-containing blood product (refer to 4.20 Tuberculosis).

In persons with agammaglobulinaemia who are receiving monthly NHIG, the use of live vaccines is not recommended as the immune response may be inhibited. In addition, these people will have sufficient circulating antibody (e.g. measles, varicella) from the NHIG to protect them in the case of exposure. Inactivated vaccines are recommended as per the routine schedule; the response may be suboptimal, but these vaccines are safe to administer.

Persons, who have received a blood transfusion, including mass blood transfusions, do not require any past vaccinations to be repeated. However, following the receipt of any blood product, including plasma or platelets, an interval of 3 to 11 months should elapse, dependent on the blood product transfused, before vaccination with an MMR, MMRV or varicella vaccine (refer to Table 3.3.6 Recommended intervals between either immunoglobulins or blood products and MMR, MMRV or varicella vaccination). An interval is suggested because there may be low levels of antibodies present in the blood product that may impair the immune response to the live vaccine.

Table 3.3.6: Recommended intervals between either immunoglobulins or blood products and measles-mumps-rubella (MMR), measles-mumps-rubella-varicella (MMRV) or varicella vaccination*180
Immunoglobulin/blood product Route Dose
Estimated
mg IgG/kg
Dose
IU or mL
Interval (months)
Blood transfusion:
Washed RBCs

IV

10 mL/kg

Negligible

0
RBCs, adenine-saline added IV 10 mL/kg 10 3
Packed RBCs IV 10 mL/kg 20–60 5
Whole blood IV 10 mL/kg 80–100 6
Cytomegalovirus immunoglobulin IV 3 mL/kg 150 6
HBIG as hepatitis B prophylaxis IM 100 IU
400 IU
10 3
NHIG (intravenous) for ITP treatment IV 400 8
NHIG (intravenous) for ITP treatment IV 1000 10
NHIG (intravenous) for ITP or Kawasaki disease treatment IV 1600–2000 11
NHIG as hepatitis A prophylaxis IM 0.5 mL (<25 kg)
1.0 mL (25–50 kg)
2.0 mL (>50 kg)
3
NHIG as measles prophylaxis:
Standard
Immunocompromised
IM
IM
(max. dose 15 mL)
0.2 mL/kg
0.5 mL/kg
5
6
Plasma or platelet products IV 10 mL/kg 160 7
HRIG as rabies prophylaxis IM 20 IU/kg 22 4
Replacement (or therapy) of immune deficiencies (as NHIG [intravenous], various doses) IV 300–400 9
Rh (D) IG (anti-D) IM 0
TIG (IM use) for tetanus prophylaxis IM 250 IU (given within 24 hours
of injury)
500 IU (>24 hours after injury)
10


20
3
ZIG as varicella prophylaxis IM 200 IU (0–10 kg)
400 IU (11–30 kg)
600 IU (>30 kg)
5

* Zoster vaccine can be given at any time before or after administration of immunoglobulin or any antibody-containing blood product.

3.3.5 Vaccination of persons with bleeding disorders

Persons who are receiving anticoagulant therapy may develop haematomas in IM injection sites. The length of anticoagulant therapy should be clarified and immunisation delayed if therapy is going to be of short-term duration. Unless warfarin or low molecular weight heparin (LMWH) doses are known to be stable, persons receiving anticoagulants should have appropriate levels checked before vaccine administration, if possible. Intramuscular injections should be deferred if the INR is >3.0 (warfarin) or the anti-Xa (LMWH) level 4 hours post dose is >0.5 Units/mL.

If a person has haemophilia and is receiving clotting factor replacement or similar therapy, IM vaccine administration should be conducted as soon as possible after the medication is received.180 The site should not be rubbed post administration, but firm pressure applied for approximately 5–10 minutes. Vaccine recipients and/or carers should be informed about the possibility of haematoma formation. Ice and immobilisation may be used in the case of a small haematoma. The subcutaneous route could be considered as an alternative in a person with haemophilia or on anticoagulant therapy; however, the intramuscular route is preferred if that is the usual recommended mode of vaccine administration – seek expert advice. If a vaccine is administered subcutaneously, there may be diminished immune response (e.g. requirement to check anti-HBs antibodies) and additional vaccine doses may be required.181,182

3.3.6 Vaccination before or after anaesthesia/surgery

Recent or imminent surgery is not a contraindication to vaccinations, and recent vaccination is not a contraindication to surgery (refer to 2.1.4 Pre-vaccination screening). There are no randomised controlled trials providing evidence of adverse outcomes with anaesthesia and surgery in recently vaccinated children. It is possible that the systemic effects from recent vaccination, such as fever and malaise, may cause confusion in the post-operative period. As the evidence is limited, it is possible to administer vaccines as per the routine schedule, or electively during a procedure for a person in a special risk group, if the appropriate vaccine delivery safety mechanisms are in place.183

If elective surgery and anaesthesia are to be postponed, some guidelines recommend postponing for 1 week after inactive vaccination and for 3 weeks after live attenuated viral vaccination in children. Routine vaccination may be deferred for 1 week after surgery.184

A person who receives any blood products during surgery will need to be informed of the need to delay some vaccinations (refer to Table 3.3.6 Recommended intervals between either immunoglobulins or blood products and MMR, MMRV or varicella vaccination).

3.3.7 Vaccination of persons at occupational risk

Certain occupations, particularly those associated with healthcare, are associated with an increased risk of some vaccine-preventable diseases.185,186 Furthermore, some infected workers, particularly healthcare workers and those working in early childhood education and care, may transmit infections such as influenza, rubella, measles, mumps, varicella and pertussis to susceptible contacts, with the potential for serious health outcomes. Many infectious diseases, measles in particular, are highly infectious several days before symptoms become apparent. Healthcare workers employed within the public health system should check local state or territory healthcare worker immunisation requirements and the necessary documentation required (refer to Appendix 1 Contact details for Australian, state and territory government health authorities and communicable disease control).

Where workers are at significant occupational risk of acquiring a vaccine-preventable disease, the employer should implement a comprehensive occupational vaccination program, which includes a vaccination policy, current staff vaccination records, provision of information about the relevant vaccine-preventable diseases, and the management of vaccine refusal (e.g. reducing the risk of a healthcare worker transmitting disease to vulnerable persons). Employers should take all reasonable steps to encourage non-immune workers to be vaccinated.

Current recommended vaccinations for persons at risk of occupationally acquired vaccine-preventable diseases are listed in Table 3.3.7. In addition to the vaccines specific to a person’s occupation and work-related activities recommended here, all adults should be up to date with routinely recommended vaccines, such as dT-containing and MMR vaccines. (Refer also to Table 2.1.12 in 2.1.5 Catch-up.)

Standard precautions should be adopted where there is risk of occupational exposure to blood and body fluids. Preventive measures include the appropriate handling and disposal of sharps, the donning of gloves when handling body fluids, and the use of goggles/face shields when splashes are likely.

If a non-immune person is exposed to a vaccine-preventable disease, post-exposure prophylaxis should be administered where indicated (refer to relevant disease-specific chapters in Part 4, and Part 5 Passive immunisation).

Table 3.3.7: Recommended vaccinations for persons at increased risk of certain occupationally acquired vaccine-preventable diseases*†
Occupation Vaccine
Healthcare workers (HCW)
All HCW
Includes all workers and students directly involved in patient care or the handling of human tissue, blood or body fluids
Hepatitis B
Influenza
MMR (if non-immune)
Pertussis (dTpa)
Varicella (if non-immune)
HCW who work in remote Indigenous communities or with Indigenous children in NT, Qld, SA and WA, and other specified healthcare workers in some jurisdictions Vaccines listed for ‘All HCW’, plus hepatitis A
HCW who may be at high risk of exposure to drug-resistant cases of tuberculosis (dependent on state or territory guidelines) Vaccines listed for ‘All HCW’, plus consider BCG
Persons who work with children
All persons working with children, including:
  • staff and students working in early childhood education and care
  • correctional staff working where infants/children cohabitate with mothers
  • school teachers (including student teachers)
  • outside school hours carers
  • child counselling services workers
  • youth services workers
Influenza
MMR (if non-immune)
Pertussis (dTpa)
Varicella (if non-immune)
Staff working in early childhood education and care Vaccines listed for ‘Persons who work with children’, plus hepatitis A
Carers
Carers of persons with developmental disabilities § Hepatitis A
Hepatitis B
Influenza
Staff of nursing homes and long-term care facilities for persons of any age § Influenza
MMR (if non-immune)
Varicella (if non-immune)
Providers of home care to persons at risk of high influenza morbidity Influenza
Emergency and essential service workers
Police and emergency workers Hepatitis B
Influenza
Tetanus (dT or dTpa)
Armed forces personnel Hepatitis B
Influenza
Meningococcal B (MenBV)
MMR (if non-immune)
Tetanus (dT or dTpa)
Other vaccines relevant to deployment
Staff of correctional facilities Hepatitis B
Influenza
MMR (if non-immune)
Tetanus (dT or dTpa)
Staff of detention and immigration centres Hepatitis B
Influenza
MMR (if non-immune)
Tetanus (dT or dTpa)
Laboratory personnel
Laboratory personnel handling veterinary specimens or working with Q fever organism ( Coxiella burnetii) Q fever
Laboratory personnel handling either bat tissues or lyssaviruses (including rabies virus and Australian bat lyssavirus) Rabies

Laboratory personnel routinely working with these organisms:
Bacillus anthracis
Vaccinia poxviruses
Poliomyelitis virus
Salmonella enterica subspecies enterica serovar Typhi (S. Typhi)
Yellow fever virus
Neisseria meningitidis


Japanese encephalitis virus


Anthrax
Smallpox
Poliomyelitis (IPV)
Typhoid
Yellow fever
Quadrivalent meningococcal conjugate vaccine (4vMenCV)# Meningococcal B (MenBV)

Japanese encephalitis

Persons who work with specific communities
Workers who live with, or make frequent visits to, remote Indigenous communities in NT, Qld, SA and WA Hepatitis A
Workers assigned to the outer Torres Strait Islands for a total of 30 days or more during the wet season Japanese encephalitis
Persons who work with animals
Veterinarians, veterinary students, veterinary nurses** # Influenza
Q fever
Rabies
Agricultural college staff and students (aged >15 years) exposed to high-risk animals ** Q fever
Abattoir workers and contract workers in abattoirs (excluding pig abattoirs)
Livestock transporters
Sheep shearers and cattle, sheep and dairy farmers
Those culling or processing kangaroos or camels
Tanning and hide workers
Goat farmers
Livestock saleyard workers
Those handling animal products of conception
Q fever
Wildlife and zoo workers who have contact with at-risk animals, including kangaroos and bandicoots Q fever
Persons who come into regular contact with bats (both ‘flying foxes’ and microbats), bat handlers, bat scientists, wildlife officers, zoo curators Rabies
Poultry workers and others handling poultry, including those who may be involved in culling during an outbreak of avian influenza, and swine industry workers Influenza
Other persons exposed to human tissue, blood, body fluids or sewage
Embalmers Hepatitis B
Workers who perform skin penetration procedures (e.g. tattooists, body-piercers) Hepatitis B
Funeral workers and other workers who have regular contact with human tissue, blood or body fluids and/or used needles or syringes Hepatitis B
Plumbers or other workers in regular contact with untreated sewage Hepatitis A
Tetanus (dT or dTpa)

* Work activities, rather than job title, should be considered on an individual basis to ensure an appropriate level of protection is afforded to each worker. In addition to providing protection against certain vaccine-preventable diseases that persons in these occupations may be at increased risk of acquiring, vaccination may also reduce the risk of transmission of diseases to others with whom these persons are in contact.
† In addition to the vaccines specific to a person’s occupation and work-related activities recommended here, all adults should be up to date with routinely recommended vaccines, such as dT-containing and MMR vaccines (refer also to Table 2.1.12 in 2.1.5 Catch-up).
‡ All adults born during or since 1966 should have evidence of either receiving 2 doses of MMR vaccine or having immunity to measles, mumps and rubella. Adults born before 1966 are considered to be immune due to extensive measles, mumps and rubella circulating widely in the community during this period of time (refer to 4.9 Measles).
§ Carers of infants <6 months of age should be vaccinated against pertussis using dTpa (refer to 4.12 Pertussis).
¶ Persons with a repeated risk of exposure to, or working with large quantities or concentrations of, Bacillus anthracis or Vaccinia cultures. For information regarding anthrax or smallpox vaccination, contact the Office of Health Protection in the Australian Government Department of Health, Canberra.
# 4vMenPV can be used if the risk of exposure is not expected to be ongoing and the need for repeat doses is not anticipated (refer to 4.10 Meningococcal disease).
** Vaccines required in these occupations may depend on the animals with which the person comes in contact.

3.3.8 Vaccination of migrants to Australia

Vaccination status is not routinely assessed in children and adults entering Australia as refugees or migrants.187 Refugees or migrants may be incompletely vaccinated according to the Australian schedule or have incomplete records of vaccination.188 Most states and territories provide migrant/refugee immunisation through hospital outpatient departments. Some clinics have also linked families with local general practitioners who are of a similar ethnic and cultural background to ensure ongoing follow-up and referral where required. In addition, some local councils also provide a similar service.

Immunisation records, where available for refugees, are likely to have been given to the nominated head of the household at the refugee camp health centre. The Australian Government Department of Immigration and Citizenship (DIAC) may in some circumstances be able to provide further information regarding vaccine(s) administered to refugees before entering Australia, usually by accessing an electronic health manifest. The World Health Organization website lists immunisation schedules for most countries and may provide some information regarding vaccine schedules. (apps.who.int/immunization_monitoring/globalsummary)

If there is a valid record of vaccination from overseas, the history of previous doses should be taken into account when planning a catch-up vaccination schedule. However, some doses may be invalid, as the interval between doses may be too short. This is often the case with oral poliomyelitis vaccines and tetanus vaccines.

If a migrant/refugee has no valid documentation of vaccination, the standard ‘catch-up’ schedule should be commenced. Serological testing to determine the need for specific vaccinations is not routinely recommended in the absence of documented vaccination. However, serology should be offered to migrants from hepatitis B endemic countries to detect past (or current) infection. (Refer also to 4.5 Hepatitis B.) Serology is not routinely recommended in the absence of documentation of MMR-containing vaccines;however,testing for rubella immunity can be performed in migrant women of child-bearing age to identify women who are seronegative and require vaccination (refer to 4.18 Rubella).

If a child is ≥12 months of age, the 1st doses of DTPa, hepatitis B, IPV, MMR, MenCCV, 13vPCV and Hib vaccines can be given at the same visit. For details, refer to 2.1.5 Catch-up.

Migrant/refugee adults also need to be targeted for vaccination, especially against rubella, using MMR vaccine. This is particularly important for women of child-bearing age. Some refugees aged between 9 months and 54 years may have been offered MMR as part of a pre-departure screening, but may require a subsequent dose on arrival in Australia.refer to 2.3.4 Immunisation registers). It is particularly important to ensure that families are provided with a written record of all vaccines administered, and that all sources of vaccination records are checked prior to vaccination, as multiple immunisation providers may have been consulted after arrival.187,188

3.3.9 Vaccination of inmates of correctional facilities

Inmates of correctional facilities are at risk of acquiring influenza, hepatitis A and hepatitis B, and should be vaccinated against these infections (refer to 4.4 Hepatitis A, 4.5 Hepatitis B and refer to 4.7 Influenza).189-191 In addition, inmates of correctional facilities should be up to date with routinely recommended vaccines for adults, such as dT-containing and MMR vaccines. (Refer also to Table 2.1.122 in 2.1.5 Catch-up.)

3.3.10 Vaccination of men who have sex with men

Men who have sex with men are at risk of acquiring hepatitis A and hepatitis B,and should be vaccinated against these infections (refer to 4.4 Hepatitis A and 4.5 Hepatitis B). Human papillomavirus vaccine may also be indicated (refer to 4.6 Human papillomavirus). In addition, men who have sex with men should be up to date with routinely recommended vaccines for adults, such as dT-containing and MMR vaccines. (Refer also to Table 2.1.12 in 2.1.5 Catch-up.)

3.3.11 Vaccination of persons who inject drugs

Persons who inject drugs are at risk of acquiring hepatitis A and hepatitis B, and should be vaccinated against these infections (refer to 4.4 Hepatitis A and 4.5 Hepatitis B). In addition, persons who inject drugs should be up to date with routinely recommended vaccines for adults, such as dT-containing and MMR vaccines. (Refer also to Table 2.1.12 in 2.1.5Catch-up.)

3.3.12 Vaccination of sex industry workers

Sex industry workers are at risk of acquiring hepatitis A and hepatitis B, and should be vaccinated against these infections (refer to 4.4 Hepatitis A and 4.5 Hepatitis B). Human papillomavirus vaccine may also be indicated (refer to 4.6 Human papillomavirus). In addition, sex industry workers should be up to date with routinely recommended vaccines for adults, such as dT-containing and MMR vaccines. (Refer also to Table 2.1.12 in 2.1.5 Catch-up.)

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