EMEA Recommends Two H1N1 Vaccines for Authorization

On Sept. 25, 2009, the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline’s (GSK) Pandemrix and Novartis’s Focetria.

Pandemrix is an adjuvanted vaccine that contains an antigen of H1N1 2009 and a proprietary adjuvant system AS03. Jean Stephenne, president of GlaxoSmithKline Biologicals, stated in a company press release that, “This positive opinion means that Pandemrix will now be immediately reviewed for approval by the European Commission, which is an important step closer to helping reduce the impact of the pandemic.”

Focetria is an inactivated influenza virus vaccine indicated for active immunization of persons of six months of age and older against the influenza A (H1N1) virus. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, stated in a Novartis press release that “several recent clinical trials suggest that just one dose of pandemic vaccine can protect healthy adults, which means that now the vaccine can be provided to more people than if two doses were needed.”

CHMP made the recommendation of the two vaccines based on a “mock-up” approach of previously approved flu vaccines. CHMP is recommending “a two-dose vaccination schedule, at an interval of three weeks, for adults, including pregnant women, and children from six months of age.” According to a press release, EMEA is awaiting further data on a single dose for adults and has requested that the manufacturers of the vaccines monitor the safety of the vaccines as they begin being used by the public.

See related PharmTech articles:

NIAID Announces “Encouraging” Early Results of H1N1 Vaccine in Children (blog post)

H1N1 Vaccine Trial Data Still Needed for High-Risk Groups (blog post)

Single Dose H1N1 Vaccines Get FDA OK (ePT article)