Australian Technical Advisory Group on Immunisation (ATAGI) Statement

ATAGI Recommendations

Table 1. ATAGI recommendations for the use of 2012 seasonal influenza vaccine by brand and age group

* The age limit of less than 10 years (rather than less than 9 years) is to maintain consistency with the existing ATAGI age-based recommendations for influenza vaccines, which states that two vaccine doses are required in the first year of seasonal influenza vaccine administration for all children aged less than 10 years.

Note 1: The use of Influvac, Vaxigrip, Fluarix or Agrippal in children aged 5 years to less than 10 years is strongly preferred, however, Fluvax may be used when no timely alternative vaccine is available and parents are informed of the potential increased risk of fever.
Note 2: Do not use in children (approved for adults aged 18-59 years only).

Children aged 6 months to less than 5 years

1. Children aged between 6 months to less than 5 years should not receive Fluvax. Fluvax is not registered for use in this age group in 2012.
2. Children aged between 6 months to less than 5 years are recommended to receive any of the 4 alternative available influenza vaccines: Vaxigrip, Influvac, Fluarix or Agrippal.
3. Any one of these 4 influenza vaccines can be administered concurrently with any vaccines on the National Immunisation Program (NIP) vaccination schedule, including the supplementary dose of 13-valent pneumococcal conjugate vaccine (13vPCV) for eligible 12–35 month old children (see “Childhood Pneumococcal Immunisation” September 2011 statement at www.immunise.health.gov.au).
4. There may be a small increase in the risk of fever and febrile convulsions with the concurrent administration of trivalent influenza vaccine and 13vPCV in children aged 6 months to less than 5 years, especially those aged 12–24 months of age (see Rationale for recommendations section below). Providers should discuss this risk with parents. The option of administering these 2 vaccines separately, with an interval of at least three days between them, can be offered.

Children aged 5 years to less than 10 years

1. There is a strong preference for the use of Vaxigrip, Influvac, Fluarix or Agrippal in children aged 5 years to less than 10 years.
2. Fluvax may be used in children aged 5 years to less than 10 years when no timely alternative vaccine is available. If Fluvax is administered, parents should be informed of the potential increased risk of fever but that febrile convulsions are rare in this age group.

Adults and children aged ≥ 10 years

1. Any of the available 2012 seasonal influenza vaccines (Vaxigrip, Influvac, Fluarix, Agrippal or Fluvax) can be administered to persons aged 10 years and older in whom influenza vaccination is not otherwise contraindicated, except for Intanza which can only be used in adults aged 18 to 59 years.
2. Influenza vaccination is strongly recommended for pregnant women and is funded under the NIP for this indication (see General recommendations below). There is no preference for any brand of influenza vaccine in pregnancy; all are considered acceptable for use in pregnant women.

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General recommendations for influenza vaccination in children and adults

1. Annual influenza vaccination is strongly recommended in the following groups who are at an increased risk of influenza complications. Persons in these categories are able to obtain influenza vaccine under the NIP (Fluarix, Fluvax or Vaxigrip):
   •   persons aged 65 years and older;
   •   persons aged 6 months and older with medical conditions;
   •   pregnant women; and
   •   persons aged 15 years and older who identify as Aboriginal or Torres StraitIslander.
2. Children aged 6 months to less than 10 years of age require two doses of seasonal influenza vaccine if they have not received two doses of seasonal influenza vaccine in a previous year. A minimum interval of 4 weeks after the first dose should elapse before administering the second dose.
3. Annual influenza immunisation is strongly recommended for any adult or child
   (> 6 months of age) who wishes (or whose parents wish them) to be protected against influenza. Seasonal influenza vaccination is not funded under the NIP for non-indigenous people < 65 years of age who do not have a medical condition or other risk factor (Table 2) that places them at increased risk of influenza complications but can be obtained privately through their immunisation provider.
4. Annual influenza immunisation is strongly recommended for all household contacts of children and adults with a medical condition placing them at increased risk of influenza complications.1 Seasonal influenza vaccine is not funded under the NIP for this indication, but can be obtained privately through their immunisation provider.
5. Influenza immunisation is recommended annually, even if a person has been vaccinated in the previous year/s with an influenza vaccine that contains the same strains. This is because the immunity to influenza acquired by vaccination wanes rapidly over time.

Rationale for recommendations

Children aged 6 months to less than 5 years

•   The expected rate of febrile convulsions following administration of seasonal trivalent influenza vaccines (other than Fluvax or Fluvax Junior) is less than 1 per 1000 doses in this age group.2-5
•   During 2010, the rate of febrile convulsions in children under 5 years of age vaccinated with the Fluvax or Fluvax Junior was up to 1 per 100 (1%).2-4
•   There was no increase in risk of fever or febrile convulsions following administration of either Vaxigrip or Influvac vaccines. 2-5
•   In preparation for the 2012 influenza season, the sponsors of Agrippal and Fluarix submitted data to the TGA to support the safety of their vaccines in children, including the experience with their vaccines in both the northern and southern hemisphere winters. These data raise no significant safety concerns related to fever or febrile convulsions in children.
•   A study from the US Vaccine Safety Datalink surveillance system has shown an increased risk of febrile convulsions occurring within 1 day following vaccination of children (aged 6 months to less than 5 years) who received the 13vPCV concurrently with a first dose of inactivated trivalent influenza vaccine. The likelihood of febrile convulsions associated with concurrent administration of these two vaccines was greater than following receipt of either of the vaccines alone (incidence rate ratio of 5.9 versus 2.4 or 2.5, respectively).6 The risk of febrile convulsions following concomitant administration was highest for those

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aged 12–24 months, with a peak attributable risk at age 16 months of 45 per 100 000 doses, but overall remains acceptable.

Although the 13vPCV and trivalent seasonal influenza vaccine may be given concurrently to children 12 months to 35 months of age, providers should discuss the small increased risk of fever and febrile convulsion following co-administration with parents. If there are strong parental concerns, the option of administering these 2 vaccines separately, with an interval of at least three days between them, should be offered.

Children aged 5 years to less than 10 years

•   Complications of fever, such as febrile convulsions, are rare in this age group.
•   Available data have not indicated any increased association with fever or febrileconvulsions following Vaxigrip, Influvac, Fluarix or Agrippal vaccines in this age group.
•   Data extrapolated from a randomised controlled trial conducted in the USA showed asignificant increase in fever in children aged 5 through 8 years following administration of the 2009 northern hemisphere formulation of Fluvax (marketed as Afluria in the US, and not containing the pandemic H1N1 strain) versus a comparator vaccine. This difference is presumed to apply at least as strongly to the Fluvax/Afluria vaccine in 2010 and 2011 in the USA and in Australia.7 As a result of these findings, Fluvax/Afluria vaccine was not recommended for this age group in the USA for the 2010-11 and 2011-12 influenza seasons,7, 8 and was not recommended for use in children up to 10 years of age in Australia in 2011 nor is it recommended for this year, 2012. However, as febrile convulsions are rare after the age of 5 years, the use of Fluvax can be considered in children aged 5 to less than 10 years if it is the only available vaccine and parents are informed of the increased risk of fever.
•   The age limit of less than 10 years (rather than less than 9 years in the USA) for the preference for Vaxigrip, Influvac, Fluarix or Agrippal is to maintain consistency with the existing ATAGI age-based recommendations for influenza vaccines that two doses of influenza vaccine are required in the first year of seasonal influenza vaccine administration for all children aged less than 10 years.Persons 10 years of age and older
  •   In 2011, a Joint ATAGI/TGA Working Group reviewed data on adverse events related to seasonal influenza vaccines in children aged ≥ 10 years and adults. The review concluded that, on balance, the risk for adverse events following administration of Fluvax is likely to be modestly higher than following either Vaxigrip or Influvac.9 This is most marked for the 2010 vaccine and the evidence predominantly supported an increased risk of injection site reactions.
  •   Despite the possibility of a modest increased risk for adverse events in Fluvax recipients, it was considered that the absolute rate of adverse events in children aged ≥ 10 years and adults following Fluvax is within an acceptable range.
  •   The Working Group’s report is available on the Immunise Australia website at: www.immmunise.health.gov.au
  •   There is no change to ATAGI recommendations for this age group.
  •   Any of the available 2012 seasonal influenza vaccines can be administered in persons10 years of age and older, in whom vaccination is not otherwise contraindicated, noting that Intanza is only registered for use in adults aged 18 to 59 years.For more detailed background on influenza, influenza vaccines and febrile convulsions, see previous ATAGI statements at: www.immunise.health.gov.auHow to report adverse events following immunisation

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•   Immunisation service providers with any concerns regarding patients experiencing an adverse event following influenza vaccination (or any vaccine) should contact their relevant state or territory health department.
•   Parents/guardians or other persons who are worried about an adverse reaction following influenza vaccination (or any other vaccine) should contact their GP in the first instance or if the reaction is causing concern they should attend their nearest hospital emergency department.Alternatively parents/guardians or other persons wishing to report an adverse event following influenza vaccination (or any other medication including vaccines) can contact the Consumer Adverse Medicine Events Line on telephone number 1300 134 237.
  This phone-in service, provided by the Mater Hospital, Brisbane, is available for members of the general public who suspect they have experienced an adverse medicine event.
  The service forwards reports of suspected adverse reactions to the TGA. Anyone can repost an adverse event directly to the TGA through the ‘Report a problem’ link on the TGA website at www.tga.gov.au

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References

1. National Health and Medical Research Council. The Australian Immunisation Handbook. 9th ed. Canberra: Australian Government Department of Health and Ageing, 2008
2. Therapeutic Goods Administration. Investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination Status report as at 2 July 2010. www.tga.gov.au/safety/alerts-medicine-seasonal-flu- 100702.htmhttp://www.tga.gov.au/alerts/medicines/fluvaccine-report100702.htm Accessed 7 January 2011.
3. Therapeutic Goods Administration Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children
   8 October 2010 www.tga.gov.au/safety/alerts-medicine-seasonal-flu- 101008.htmhttp://www.tga.gov.au/alerts/medicines/vaccine-overview.htm Accessed 7 January 2011.
4. Department of Health and Ageing ATAGI Vaccine Advice ATAGI Statement: Clinical advice for immunisation providers on resumption of the use of 2010 trivalent seasonal vaccines in children less than 5 years of age: 30 July 2010 immunise.health.gov.au/internet/immunise/Publishing.nsf/content/immunise-atagi-statement-tiv Accessed 7 January 2011.
5. New Zealand Ministry of Health. Fever and convulsions in children receiving flu vaccine. Wellington, New Zealand: New Zealand Ministry of Health; 2010. www.moh.govt.nz/moh.nsf/indexmh/fever- and-convulsions-in-children-receiving-flu-vaccine?open Accessed 7 January 2011.
6. Tse A, Tseng HF, Greene SK, et al. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010– 2011. Vaccine 2012;30:2024-31.
7. US Food and Drug Administration. Afluria, influenza virus vaccine 2010 [package insert]. CSL Limited; Food and Drug Administration; 2010. Available at www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm220730.pdf Accessed 7 January 2011.
8. Update: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Use of CSL Seasonal Influenza Vaccine (Afluria) in the United States During 2010—11 Weekly August 13, 2010 / 59(31);989-992. www.cdc.gov/mmwr/preview/mmwrhtml/mm5931a4.htm
   Accessed 7 January 2011.
9. Joint Australian Technical Advisory Group on Immunisation (ATAGI) and Therapeutic Goods Administration (TGA) Seasonal Influenza Vaccine Safety Ad Hoc Working Group. Review of data on the safety of seasonal influenza vaccines, particularly Fluvax (CSL Biotherapies) in adults and
   children >10 years; 2012. www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/review-fluvax
   Accessed 2 March 2012.

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