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EMEA recommends approval of GlaxoSmithKline's and Novartis'
influenza A (H1N1) vaccines
 
 
  by Matthew Dennis
Last Updated:September 25, 2009 11:39
 
The European Medicines Agency announced that its scientific committee issued positive opinions for approval of two vaccines against influenza A (H1N1) from GlaxoSmithKline and Novartis. A final decision from the European Commission on whether the vaccines, called Pandemrix and Focetria, will be granted marketing authorisation is expected shortly.
 
Both vaccines were authorised using the "mock-up" approach and under an expedited review process. Focetria, which was previously approved by the EU in May 2007 to be used in the event of an influenza pandemic, contains Novartis' MF59 adjuvant, while GlaxoSmithKline's vaccine, which was approved in Europe in May last year, is adjuvanted with the company's AS03 system.
 
The committee noted that although preliminary data suggest that one dose of the vaccines may be sufficient in adults, it is currently recommending a two-dose schedule given three weeks apart for adults and children older than six months. The EMEA said it "is expecting further data from ongoing clinical studies over the coming months," which may lead to the recommendations being updated.
 
The agency added that other applications are still under review, including one additional mock-up vaccine.
 
Reference Articles
 
UK swine flu vaccine 'approved'- (BBC News)
 
European agency: License 2 swine flu vaccines - (CNBC)
 
European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009 - (EMEA)
 
Green light for swine flu vaccines - (Financial Times)
 
EU agency recommends two H1N1 flu vaccines - (Forexyard)
 
GSK's H1N1 'Pandemrix' vaccine receives positive opinion from European regulators - (GlaxoSmithKline)
 
Novartis A (H1N1) pandemic influenza vaccine Focetria receives positive opinion from CHMP - (Novartis)
 
Swine flu vaccine approved for use - (The Telegraph)
 
European Medicines Agency recommends Glaxo, Novartis swine flu vaccines - (The Wall Street Journal)
 
Swine flu vaccines get approval - (Times of the Internet)
 
 
 
 
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