European Medicines Agency updates on pandemic medicines
Press releaseMedicines
The European Medicines Agency has reviewed further data on the centrally authorised pandemic medicines, the pandemic influenza vaccines Celvapan, Focetria and Pandemrix, and the antiviral Tamiflu. In the European Union at least 26 million people have been vaccinated so far and worldwide 13 million patients have taken Tamiflu from 1 May 2009 to 31 October 2009. The Agency has reaffirmed their positive balance of benefits and risks in the context of the current H1N1 influenza pandemic.
The immunogenicity data submitted for Focetria and Pandemrix confirm the currently approved dosing schedule, namely that a single dose of these vaccines is able to trigger an immune response that may be sufficient in some age groups to give protection against the H1N1 pandemic influenza.
On 16 December 2009, the Agency published the third in its series of weekly pandemic influenza pharmacovigilance update reports. The benefit/ risk balance of the pandemic vaccines and Tamiflu used for the current H1N1 influenza pandemic continues to be positive. The latest data on the safety of the three pandemic vaccines and Tamiflu show no unexpected serious safety issues. The most frequent adverse reactions that have been reported are non-serious and as expected.
The Agency will continue to closely monitor the vaccines and publish its regular pandemic influenza pharmacovigilance updates (the fourth report will be published on 23 December 2009 and the fifth report on 6 January 2010). The Agency will evaluate all information that becomes available and make further recommendations as necessary.