FDA approves vaccines for upcoming flu season

July 24, 2009

The U.S. Food and Drug Administration has announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The U.S. Food and Drug Administration has announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States. The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009.

The FDA continues to work with manufacturers, international partners, and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus. Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for Americans in high-risk groups to receive the seasonal influenza vaccine.

No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths. “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 FDA Commissioner Margaret A. Hamburg, MD. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL; Fluarix, GlaxoSmithKline; FluLaval, ID Biomedical; Fluvirin, Novartis; Fluzone, Sanofi Pasteur; and FluMist, MedImmune.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season. On the basis of those forecasts and recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year.

More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical. In addition, immunization of healthcare personnel is important in protecting them and others from influenza.