Regulatory Roundup: EMEA Reaffirms Efficacy of Two H1N1 Vaccines

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency confirmed the safety and efficacy of Focetria and Pandermix, and noted that data on Celvapan are still being analyzed.

The European Medicines Agency (EMEA) released a statement reaffirming the efficacy and safety of the influenza A (H1N1) vaccines Focetria (Novartis, Basel) and Pandemrix (GlaxoSmithKline, London) after the agency had comducted further data review. EMEA indicated that a single dose of these vaccines is able to trigger an immune response against H1N1 in adults aged 18 and 60 and in children and adolescents (from the age of 9 years for Focetria, and from 10 years for Pandemrix). Pandemrix may also be used as a single dose in the elderly. For younger children and people with compromised immune systems, EMEA recommends that two doses be given for an adequate immune response. EMEA said that data on Celvapan (Baxter, Deerfield, IL) are still being assessed. The agency also stated that Focetria and Pandemrix can be co-administered with nonadjuvanted seasonal flu vaccines.