May/June 2009

FDA Approves 2009-2010 Seasonal Influenza Vaccine

FDA officials have announced that a vaccine for the 2009-2010 seasonal influenza in the United States has been approved.

The vaccine for the 2009-2010 seasonal influenza contains three strains of influenza: an A/Brisbane/59/2007 (H1N1)-like virus, an A/Brisbane/10/2007 (H3N2)-like virus and a B/Brisbane/60/2008-like virus.

“The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” cine each year is a critical tool in protecting public health.” Margaret A. Hamburg, MD, FDA commissioner, said in a press release. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

FDA officials noted that the 2009-2010 seasonal influenza vaccine will not protect against influenza A (H1N1), the virus that resulted in the declaration of a pandemic by the World Health Organization earlier this year. However, they said they are continuing to work with manufacturers, international partners and other government agencies to make available a safe and effective vaccine against influenza A (H1N1).

Cumulative 2009/2010 Season Lot Release Status (Updated 7/30/2009)

Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers. For information on flu vaccine distribution schedules, please contact the manufacturers directly.
 

Vaccine & Manufacturer Total number of Lots Released by FDA
FluMist
MedImmune, LLC
5
Fluvirin
Novartis Vaccines and Diagnostics Limited
1
Fluzone
Sanofi Pasteur, Inc.
11

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on February 18, 2009, to select the influenza virus strains for the composition of the influenza vaccine for use in the 2009-2010 U.S. influenza season. During this meeting, the advisory panel reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics, serological responses to 2008/2009 vaccines, and the availability of candidate strains and reagents.

Approved Influenza Vaccines

Read the complete FDA article.

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