Monday, November 23, 2009
Protein Sciences Corp. may be one step closer to approval of what would be the
first cell culture-derived flu vaccine after an FDA advisory committee voted
last week in favor of its use in adults ages 18-49. However, the panel
concluded the available data were not yet sufficient to support the safety of
FluBlok in people ages 50 and up, not because of doubts about the novel
manufacturing technology, but rather because of a few rare events, combined
with a small safety database.
There are five trivalent inactivated influenza vaccines
approved for use in the U.S. A sixth approved vaccine, FluMist from AstraZeneca plc's MedImmune LLC unit, is a live attenuated vaccine. All are
manufactured using hen eggs.