FDA Approves Influenza Vaccine for 2009-2010 Season

by: Yael Waknine

MEdscape Medical News

July 21, 2009 — The US Food and Drug Administration has approved a vaccine for the 2009–2010 US influenza season.

Although the vaccine will not protect individuals against the H1N1 influenza A pandemic viral strain, the agency emphasizes the importance for Americans to continue receiving prophylaxis against the seasonal influenza strains that are expected to circulate this year. These include an A/Brisbane/59/2007 (H1N1)-like virus, an A/Brisbane/10/2007 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus.

According to the Centers for Disease Control and Prevention, more than 200,000 individuals are hospitalized and about 36,000 die each year from influenza-related complications. Those at increased risk for potentially fatal complications include the elderly, young children, and people with chronic medical conditions.

“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,” said Margaret A. Hamburg, MD, FDA commissioner of food and drugs, in an FDA news release. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

As such, this year’s influenza vaccine will be marketed as Afluria (CSL Limited), Fluarix (GlaxoSmithKline Biologicals), FluLaval (ID Biomedical Corporation), Fluvirin (Novartis Vaccines and Diagnostics Limited), Fluzone (Sanofi Pasteur Inc), and FluMist (MedImmune Vaccines Inc).

According to the news release, the FDA continues to work with manufacturers, international partners, and other governmental agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

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