Vaccine for 2009 H1N1 Influenza Approved by FDA
September 16, 2009
Vaccine for 2009 H1N1 Influenza Approved by FDA
Four H1N1 influenza vaccines were approved by the U.S. Food and Drug Administration (FDA).  The announcement  by the FDA on September 15, 2009  stated that the first lots are expected to be available within the next four weeks and will then be distributed across the U.S.  Preliminary studies show that adults participating in multiple clinical trials with the 2009 H1N1 vaccine induce a robust immune response eight to 10 days after a single dose.  Currently studies are underway that will provide information about the optimal dose in children.

“The H1N1 vaccines approved undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.  Potential side effects to the vaccine are expected to be similar to those of seasonal flu vaccines and the FDA is working closely with organizations and agencies to increase the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination campaign.


See also:

FDA News Release: FDA Approves Vaccines for 2009 H1N1 Influenza Virus

CDC: Flu.gov

CHHCS: News Alert - CDC Releases Update on Interim Recommendations for K-12 Schools in Response to H1N1