Chief Medical Officer Advice

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7 March 2011: Seasonal Influenza Vaccination

I am writing to update you on the arrangements for seasonal influenza vaccination under the National Immunisation Program (NIP) for 2011. The program will commence on 15 March and vaccine stock will be available in all practices by this date. In the Northern Territory (which experiences an earlier influenza season) vaccine stock will be available earlier. The groups eligible for free influenza vaccine are listed in the enclosed Fact Sheet.

The composition of the seasonal influenza vaccine in 2011 is the same as in 2010, covering pandemic H1N1 2009, H3N2 and B strains. All of these occurred in Australia last year and have been circulating during the Northern Hemisphere winter season. At the end of February 2011, the dominant virus in North America was H3N2 while, in Europe, B and pandemic (H1N1) 2009 viruses were the most common. In Europe, pandemic H1N1 2009 virus has been over-represented among the severe cases, which have occurred in the highest number in the 15 to 64 years age group. The majority of these cases have had underlying medical risk factors and most have been unvaccinated. This reinforces the importance of influenza vaccination for people with chronic conditions. Patients should also be advised that, even if they had the seasonal influenza vaccine in 2010, annual vaccination is necessary due to waning immunity.

Following the investigation of the febrile reactions to the 2010 influenza vaccine in children, the Australian Technical Advisory Group on Immunisation (ATAGI) has advised that children aged between 6 months to less than 5 years should not receive the 2011 Fluvax® vaccine and Fluvax® is not registered for use in this age group in 2011. The alternative influenza vaccines available for paediatric use are Vaxigrip® or Influvac®. ATAGI has also advised a strong preference for the use of either Vaxigrip® or Influvac® in children aged 5 years to less than 10 years. Fluvax® may be used in children aged 5 years to less than 10 years when no timely alternative vaccine is available. The full ATAGI statement which includes the rationale for these recommendations is available at www.immunise.health.gov.au

The events of last year illustrated the importance of monitoring influenza vaccine usage in children. To assist in this I would ask you to notify the Australian Childhood Immunisation Register when you administer influenza vaccine to a child aged up to 7 years. I also encourage you to report any adverse events following influenza vaccine to the Therapeutic Goods Administration through the usual reporting mechanisms in your State or Territory.

Yours sincerely

Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA
7 March 2011

Printable version of CMO advice 7 March 2011 (PDF 92 KB)

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Information on 2010 Seasonal Influenza

30 July 2010: Children under 5 years of age can now be vaccinated against influenza using Vaxigrip® or Influvac® seasonal influenza vaccine.

I am writing to provide information on the progress of the investigations into the increase in the numbers of young children experiencing fever and febrile convulsions after seasonal influenza vaccination. The epidemiological investigations both in Australia and internationally have confirmed the increase in the rate of febrile convulsions in children less than 5 years of age in the 24 hours after vaccination with the 2010 seasonal trivalent influenza vaccine (TIV). Despite extensive investigation by the Therapeutic Goods Administration (TGA) a cause for this increase has not yet been identified however additional, more sensitive tests are on-going.

The increase in rates of febrile convulsions has been documented for the 2010 Fluvax® and Fluvax® Junior. Investigations from New Zealand where Vaxigrip® has been widely used during the 2010 influenza season did not demonstrate any increase in rates of febrile convulsions. Analysis of Australian data for Influvac® also does not demonstrate any increase in rates of febrile convulsions.

The TGA considers that, overall, the balance of benefits and risks of Fluvax® and Fluvax® Junior continues to be positive but has required a new warning to be inserted in the product information for these vaccines to alert clinicians to the increased rate of high fever and febrile convulsions with their use in children less than 5 years of age.

As a result of these investigations, we recommend that children from 6 months to less than 5 years of age may be vaccinated with Vaxigrip® and Influvac® following a discussion of the risks and benefits of these vaccines with parents and guardians. This includes both children at risk of medical complications of influenza and healthy children. Vaccination of children in this age group with Fluvax® and Fluvax® Junior is not recommended due to the identified increase risk of febrile convulsions.

Children less than 5 years of age with predisposing medical conditions are between 2 to 6 times more likely to be hospitalised following an influenza infection compared with healthy children.

Despite the reassuring epidemiological evidence of no increased rate of febrile convulsions with Vaxigrip® and Influvac®, febrile convulsions after influenza vaccination can occur although this is an uncommon event. Parents should be made aware of the possibility and the child should be monitored for fever. Paracetamol and physical methods can be used to reduce fever.

Recommendations for the use of seasonal influenza vaccine including Fluvax® in children 5 years and older and in adults has not changed. The recommendation to avoid Fluvax® is limited to children aged 6 months to less than 5 years of age.

Further information about the investigation findings are provided in the enclosed Fact Sheet. Copies of this letter, the Fact Sheet, Australian Technical Advisory Group on Immunisation (ATAGI) advice for clinicians on the 2010 trivalent influenza vaccine for healthy children aged 6 months to less than 5 years, ATAGI advice for clinicians on the benefits and risks of influenza vaccination for children aged 6 months to less than 5 years and a recent media release are posted on the Immunise Australia website at www.immunise.health.gov.au. Additional information can be accessed on the same website or by phoning the Immunise Australia Call Centre on 1800 671 811.


Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA
30 July 2010

Printable version of CMO advice 30 July 2010 (PDF 74 KB)

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1 June 2010: CMO letter to Immunisation Providers on use of seasonal influenza vaccine in children under 5 years of age

I am writing to provide information on the interim findings of the investigation into the apparent increase in the numbers of young children experiencing fever and febrile convulsions after seasonal influenza vaccination. The investigation has confirmed an increase in the rate of febrile convulsions in children aged under 5 years in the 24 hours after vaccination with the 2010 seasonal trivalent influenza vaccine (TIV), but has not identified the cause of this increase.

The increase in rates of febrile convulsions has been documented for the 2010 Fluvax® and Fluvax® Junior. At this stage, no increase has been documented with Influvac® or Vaxigrip®. While there has not been sufficient use of either of these vaccines in young children in Australia to rule out the possibility of similar increases in fever rates, investigations are ongoing.

The Therapeutic Goods Administration (TGA) considers that, overall, the balance of benefits and risks of Fluvax® and Fluvax® Junior continues to be positive but has required a new warning to be inserted in the product information for these vaccines to alert clinicians to the increased rate of high fever and febrile convulsions with their use in children aged under 5 years.

As a precaution, we recommend healthy children aged under 5 years should not be vaccinated with any of the 2010 TIVs until further notice. As an alternative, children may be vaccinated with the pandemic H1N1 vaccine (Panvax®), which is not affected by the suspension.

Children aged under 5 years with predisposing medical conditions are between 2 to 6 times more likely to be hospitalised following an influenza infection compared with healthy children. Where a child has medical risk factors, vaccination with Panvax® may be given. For broader protection, vaccination with one of the 2010 seasonal vaccines, with a preference for Influvac® or Vaxigrip® (where available), may be considered, based on a clinical evaluation of the risks and benefits for the individual child and agreement on the best clinical management with the parents.

Despite the documented increase, febrile convulsions after influenza vaccination continue to be uncommon events, but parents should be made aware of the possibility and the child should be monitored for fever. Paracetamol and physical methods can be used to reduce fever.

Recommendations for the use of seasonal influenza vaccine in children 5 years and older and in adults and for the use of Panvax® in anyone aged 6 months and over have not changed. In particular, those who are at increased risk of severe complications from seasonal influenza¹ should continue to be vaccinated.

Further information about the ongoing investigation and the findings to date is provided in the enclosed Fact Sheet. Copies of this letter, the Fact Sheet and a recent media release are posted on the Immunise Australia website at www.immunise.health.gov.au Additional information can be accessed on the same website or by phoning the Immunise Australia Call Centre on 1800 671 811.


Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA
1 June 2010

See pages 190 to 192 in the Australian Immunisation Handbook 9th Edition, accessible via the Immunise Australia website at http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook-home</p>]

Printable version of CMO advice 1 June 2010 (PDF 78 KB)

CMO media release - 1 June 2010: Investigation Into Febrile Convulsions In Young Children After Seasonal Influenza Vaccination Interim Findings And Recommendations 1 June 2010

23 April 2010: CMO letter to Immunisation Providers on temporary suspension of use of seasonal influenza vaccine in children aged 5 years of age and under

Dear Immunisation Provider

I am writing to advise you that, until further notice, children aged 5 years and under should not be given seasonal influenza vaccine. This advice applies to all seasonal influenza vaccines. Children who have already received one dose of the vaccine and are scheduled to have a second dose should also not be given the second dose until further advised.

There has been an apparent increase in the numbers of young children in Western Australia experiencing fever and convulsions after receiving seasonal influenza vaccination. The suspension of the use of seasonal influenza vaccine in this age group is a precautionary step, pending investigation by jurisdictional and Commonwealth health authorities to establish what is causing the apparent increase.

Recommendations for the use of seasonal influenza vaccine in children 6 years and older and in adults have not changed.

The Therapeutic Goods Administration (TGA) is investigating the Western Australian data as a matter of urgency to determine whether the rates of adverse events are truly higher than expected. The TGA has contacted vaccine companies to confirm which batches of vaccine have been used in WA and will test samples from these batches in its laboratories to determine if there are any abnormalities. The TGA is convening an expert scientific advisory panel to review the information from WA and is seeking additional information from regulatory colleagues internationally.

The Department of Health and Ageing has sought advice from the Australian Technical Advisory Group on Immunisation, which is currently reviewing the available information on cases.

To date the pattern and rate of adverse reactions reported by WA have not been seen in other states. All states and territories will be reporting any additional adverse events related to seasonal influenza vaccines promptly to the TGA.

All immunisation providers are asked to report any adverse events following seasonal influenza vaccination according to their normal procedures. Reports should be made to the relevant health authority in all States and Territories, except Tasmania, where reports should be made directly to the TGA via a "Blue Card" available from the TGA website or online via the same website. Further details are at www.tga.gov.au/problem/medicines.htm

If parents or the public wish to report an adverse event directly they may contact their State or Territory health authority or the Adverse Medicine Events Line on 1300 134 237 or make a report directly to TGA online at the above website. Please make sure that the person reporting knows exactly which vaccine the person has received.

At this stage there do not appear to be implications for the swine flu vaccine Panvax®. The TGA’s assessment of clinical trials and the advice of its expert committees is that Panvax® is a safe, effective vaccine for prevention of the H1N1 influenza. Vaccination with the free Panvax® H1N1 vaccine should continue to be offered to anyone over the age of 6 months who wishes to be protected against pandemic H1N1 influenza. Although there is uncertainty about how much influenza B and H3N2 may circulate here this winter, it is likely that H1N1 will be the predominant strain.

I will advise you further as the investigation progresses.

Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA

23 April 2010


Printable version of CMO advice 23 April 2010 (PDF 79 KB)

CMO media release - 30 April 2010: Health Authorities continue to put seasonal flu vaccine on hold for young children
CMO media release - 23 April 2010: Seasonal Flu Vaccine and young children

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