BioCentury
ARTICLE | Clinical News

Focetria regulatory update

December 7, 2009 8:00 AM UTC

After a review of additional clinical data for the three approved pandemic swine influenza A (H1N1) vaccines, EMEA's CHMP said sufficient protection is provided by a single dose of Focetria adjuvanted vaccine from Novartis AG or Pandemrix adjuvanted vaccine from GlaxoSmithKline plc. The recommendation is for use of Focetria in people ages 9-60 years and for Pandemrix adjuvanted vaccine in subjects ages 10 and up, and includes use when co-administered with a non-adjuvanted seasonal influenza A (H1N1) vaccine. The committee said it is still reviewing data for Baxter's Celvapan vaccine. CHMP maintained its previous recommendation that the vaccines be administered in two doses given at least three weeks apart for younger children and immunocompromised patients (see BioCentury, Nov. 2). ...