Reactions 1321 - 2 Oct 2010

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Safety update for influenza vaccines in Europe and Australia After reviewing all the available evidence, the EMA’s CHMP has concluded that further studies are needed to fully elucidate the reported link between the influenza A virus H1N1 vaccine Pandemrix and narcolepsy.1 At present, the committee agree that the risk-benefit balance for Pandemrix is still positive, and that, while a review is ongoing, Europe-wide restrictions on use were not necessary. As of 17 September this year, 81 European reports suggestive of narcolepsy had been collected through spontaneous reporting systems, with affected patients ranging in age from 4 to 52 years. The EMA’s review is "complex", and will take 3–6 months to complete; the agency will also compare the available data from outside Europe, and is in contact with its international regulatory partners. Meanwhile, the Australian Therapeutic Goods Administration (TGA) has been monitoring reports of ADRs associated with the use of Panvax [CSL 425] during the period 30 September 2009–17 September 2010.2 To date, 1960 suspected adverse events have been reported after use of Panvax in Australia, with the majority of events described as "mild and common", such as headache and soreness or swelling at the injection site. Among the reports of suspected adverse events, 190 were associated with Panvax Junior, with fever (151) and/or vomiting (98) forming the majority of reports. However, the TGA confirms that, after assessing these data, Panvax remains a "safe, effective vaccine" for the prevention of the H1N1 influenza subtype. The TGA has also undertaken an extensive investigation following reports of an apparent increase in fever/febrile seizures among children (aged 6 months to < 5 years) after 2010 Southern Hemisphere trivalent influenza vaccine use.3 Western Australia (WA) Health suspended this year’s paediatric vaccination program on 22 April following the reports. After a detailed review, the TGA identified 100 confirmed cases of febrile convulsion in children aged < 5 years, as of 4 June 2010, of which 58 were reported from WA. Among the 100 cases, Fluvax or Fluvax Junior were used in all 66 cases where the vaccine brand was reported. Nevertheless, the TGA states that the overall riskbenefit balance of Fluvax and Fluvax Junior "remains positive", although it seems appropriate to reserve the use of seasonal influenza vaccine to children aged < 5 years for whom the risks of possible febrile reactions "are considered to be outweighed by the benefits of vaccination". 1. European Medicines Agency. European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy. Internet Document : [2 pages], 23 Sep 2010. Available from: URL: http://www.ema.europa.eu. 2. Australian Government. Suspected adverse reactions to Panvax (Rm) reported to the TGA 30 September 2009 to 17 September 2010. Internet Document : [3 pages], 22 Sep 2010. Available from: URL: http://www.tga.gov.au. 3. Australian Government. Investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination. Internet Document : [7 pages], 24 Sep 2010. Available from: URL: http://www.tga.gov.au. 801108782

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Reactions 2 Oct 2010 No. 1321