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Pandemic Influenza
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Archived advice from the Chief Medical Officer during the H1N1 2009 pandemic: 2010



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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 73 KB)
CMO Media release - 30 July 2010: Seasonal flu vaccination for young children can be resumed



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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://www.immunise.health.gov.au/



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

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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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12 February 2010: Letter to General Practitioners - Update on Pandemic (H1N1) 2009 Influenza Vaccination

Dear Colleagues,

On 4 December 2009, I wrote to primary healthcare providers about the extension of approval of Panvax H1N1® to children aged under 10 years and the availability of Panvax H1N1 Junior® for children aged under 3 years.

I am writing to you now to:
  • encourage you to offer pandemic (H1N1) 2009 vaccination to all your patients;
  • inform you of the availability of new pandemic (H1N1) 2009 influenza resources; and
  • advise you of the extension to the eligibility criteria for free seasonal influenza vaccine under the National Immunisation Program.
As you know, Pandemic (H1N1) 2009 influenza is similar to seasonal flu but different in some important ways. Compared to seasonal flu it causes more hospitalisation, more hospitalisation in children under 5 and more admissions to ICU with viral pneumonia (around 700 in 2009 with around 55 per year for the last 5 years).

Despite the considerable efforts made by primary care and other immunisation providers, vaccination coverage remains currently below what is needed to confidently protect the community against an anticipated second wave of pandemic (H1N1) 2009 influenza this year. The number of doses of vaccine distributed to date and preliminary serosurveillance data indicate that the majority of the Australian population remains unprotected from pandemic (H1N1) 2009 influenza.

Pandemic (H1N1) 2009 influenza is expected to return for a second wave. The World Health Organization reports that, while the peak of the influenza season has passed in much of the temperate northern hemisphere, virus transmission remains active in a number of countries. In most northern hemisphere countries, flu came early and more than 90% of viruses subtyped over their winter season have been pandemic (H1N1) 2009 influenza. Currently cases of pandemic (H1N1) 2009 influenza continue to occur here with around 15 confirmed cases each week.

The return of children to school in the North American autumn was associated with a substantial increase in the number of cases of pandemic (H1N1) 2009 influenza, an early start to the flu season and a higher influenza peak than usual. As the new school year gets underway in Australia, there is a risk pandemic (H1N1) 2009 influenza will start to circulate again, associated with an early influenza season here. It takes up to 2 weeks for immunity to develop following vaccination, so it is important to vaccinate anyone who wants protection against pandemic (H1N1) 2009 as soon as possible.

Vaccination should be offered to everybody, not only those in high risk groups. In the 2009 season, 38% of deaths from pandemic (H1N1) 2009 influenza occurred in people with no known risk factors and the median age of death was 53 years, compared with 83 years from seasonal influenza. It is particularly important to vaccinate children, adolescents and young adults as pandemic (H1N1) 2009 influenza spreads more readily in these age groups.

The Australian Government will be informing the general public of the importance of pandemic (H1N1) 2009 influenza vaccination in a communications campaign in the coming weeks. Please talk to your patients about the importance of getting vaccinated. Enclosed are a poster for display and a sample of a brochure for your patients to take home. Visit resources page on this website.

While the Australian 2010 seasonal trivalent influenza vaccine (TIV) will provide protection against the pandemic (H1N1) 2009 influenza strain, patients should be advised not to wait for the availability of the seasonal vaccine to be vaccinated against pandemic (H1N1) 2009 influenza. The eligibility for free TIV is restricted. Patients can be assured that it is safe to have Panvax H1N1® followed by TIV within a short period. Boosting of immunity to pandemic (H1N1) 2009 influenza will occur if the vaccines are given at least a month apart. Specific advice on the use of Panvax H1N1® and TIV in children under the age of 10 years has been developed by the Australian Technical Advisory Group.

While the Australian Government this year is expanding the eligibility for free seasonal influenza vaccine under the National Immunisation Program (NIP) seasonal vaccine supplies will be limited as usual. In addition to all people aged 65 years and over, eligibility now includes all Aboriginal and Torres Strait Islander peoples aged 15 years and over and anyone over 6 months of age who is at increased risk of complications of influenza, including those with chronic diseases and pregnant women. More detailed information about the changes to the NIP will be sent to you within the next few weeks.

Those at particular risk from seasonal influenza should be given TIV once it is available1 even if they have had Panvax H1N1®. In addition to protection against pandemic (H1N1) 2009 influenza, the TIV will protect against H3N2 and B especially relevant for older people and in line with the recommendations published on the Therapeutic Goods Administration website at http://www.tga.gov.au/committee/aivc.htm. TIV is recommended for all at risk groups in the 2010 season. However pandemic (H1N1) 2009 influenza is anticipated to be the predominant strain for the rest of the population.

While there will be sufficient TIV available this season for those who are eligible under the new NIP arrangements, there will not be sufficient TIV to vaccinate the whole population. There are plentiful supplies of Panvax H1N1® which can be offered free to anyone attending your practice especially children and young adults.

Yours sincerely
Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA

12 February 2010

1 It is anticipated that TIV vaccine for the NIP will be distributed over the period from mid March to late April 2010.


Printable version of CMO advice 12 February 2010 (PDF 86 KB)

This information is current for 24 April, 2014
This information was issued on 06 January, 2011


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