A little more than a month after clinical trials began, the FDA has approved H1N1 vaccines from four big manufacturers as it races to launch a national vaccination campaign in mid-October. And HHS Secretary Kathleen Sebelius insists that there will be plenty of vaccine available for everyone.
Vaccines from Sanofi-Aventis, CSL, Medimmune and Novartis have all been cleared, with GlaxoSmithKline still waiting for an official OK. The U.S. has contracted to buy 195 million doses of swine flu vaccine and the preliminary data from the clinical trials has underscored their efficacy, usually after a single dose. But the fast-paced development schedule is likely to only add to the fear among a sizeable segment of the population that a quick jab could carry the risk of a serious side effect. The agency, however, is doing everything it can to calm jittery nerves.
"The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," said FDA acting chief scientist Dr. Jesse Goodman. About 50 million doses should be shipped in October.
ALSO: The European Commission is urging more affluent countries to share their swine flu vaccine stockpiles with poorer nations. Report