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FDA approves vaccines for influenza A (H1N1)
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Four vaccines to protect against influenza A (H1N1) were approved by the FDA today. The four vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited and Sanofi Pasteur Inc.
Nationwide distribution of the vaccines will begin after the initial lots become available, which is expected within the next four weeks.
“Today’s approval is good news for our nation’s response to the 2009 H1N1 influenza virus,” Margaret Hamburg, MD, commissioner of the FDA, said in a press release. “These vaccines will help protect individuals from serious illness and death from influenza.”
The FDA approval was based on data from multiple clinical trials examining the vaccines’ protective effects against influenza A (H1N1) in adults. Some early data indicate that the vaccines helped to generate “a robust immune response in most healthy adults,” even after just one dose.
Clinical trials to evaluate the efficacy and safety of the vaccines in children are still underway; results of these studies are expected soon.
FDA officials said the approval process for the vaccines for influenza A (H1N1) was similar to the approval process for seasonal influenza vaccines.
“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,” Jesse Goodman, MD, FDA acting chief scientist, said in a press release.