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FDA Approves Vaccine Formulation for 2012–2013 Flu Season

Agency acknowledges that vaccine and circulating strains may not be exact match

The FDA announced on August 13 that it has approved the 2012—2013 influenza vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the U.S.

Each year experts from the FDA, the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and other public health experts study influenza virus samples and global disease patterns to identify virus strains likely to cause the most illness during the upcoming flu season.

Based on that information and the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the strains selected for inclusion in the 2012—2013 influenza vaccines are:

  • A/California/7/2009 (H1N1)-like virus
  • A/Victoria/361/2011 (H3N2)-like virus
  • B/Wisconsin/1/2010-like virus

While the H1N1 virus is the same as the one included in the 2011– 2012 influenza vaccines, this year’s influenza H3N2 and B viruses differ from those used during the 2011—2012 season.

In its announcement, the FDA noted that there is always the possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

The manufacturers licensed to produce the nation’s 2012—2013 influenza vaccines and the brand names of the vaccines for the upcoming flu season are:

  • Afluria, manufactured by CSL Limited
  • Fluarix, manufactured by GlaxoSmithKline Biologicals
  • FluLaval, manufactured by ID Biomedical Corporation
  • FluMist, manufactured by MedImmune Vaccines Inc.
  • Fluvirin, manufactured by Novartis Vaccines and Diagnostics Limited
  • Fluzone, Fluzone High-Dose, and Fluzone Intradermal, manufactured by Sanofi Pasteur

For more information, visit the FDA Web site.

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