EMEA recommends authorization of swine flu vaccines

October 2, 2009
Stephanie Sutton

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Pharmaceutical Technology Europe PTE

Two vaccines manufactured by Novartis and GlaxoSmithKline (GSK) against influenza H1N1 have been recommended by the EMEA for marketing authorization.

Two vaccines manufactured by Novartis and GlaxoSmithKline (GSK) against influenza H1N1 have been recommended by the EMEA for marketing authorization. The vaccines, Novartis's Focetria and GSK's Pandemrix, were subjected to accelerated assessment to ensure they would be available for the start of the flu season. The final decisions from the European Commission (EC) are expected shortly and vaccination strategies will then be decided by the government of each EU member state.

Currently, a two-dose vaccination schedule has been recommended for adults, including pregnant women and children older than 6 months, although the agency's CHMP has also acknowledged preliminary data that suggest a single dose may be sufficient in adults.

In a press statement, Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, said: "Several recent clinical trials suggest that just one dose of a pandemic vaccine can protect healthy adults, which means that now the vaccine can be provided to more people than if two doses were needed."

GSK also believes that a single dose may offer suitable protection. In a press release, the company referred to data that demonstrated after a single dose "the vaccine can provide a strong immune response that exceeds the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine".

In a statement, the EMEA said that it is "expecting further data from ongoing clinical studies over the coming months and these recommendations may be updated."

www.emea.europa.eu

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