August 16, 2012
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FDA approves vaccines for 2012-2013 influenza season

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The FDA announced this week the approval of the 2012-2013 influenza vaccine formulation for use in the United States, according to an FDA press release.

Perspective from Kathryn M. Edwards, MD

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; and
  • B/Wisconsin/1/2010-like virus.

The H1N1 virus included in the 2012-2013 vaccine formulation is the same as last year’s; however, this year’s influenza H3N2 and B viruses are different.

These strains were chosen based on influenza virus samples and global disease patterns compiled by the FDA, CDC and WHO, along with other public health experts. A possibility exists of a less than optimal match between the virus strains predicted to circulate and the virus strains that result in the most illness. However, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications even if the strains are not an exact match, according to the FDA.

The following manufacturers are licensed to produce this year’s influenza vaccines:

  • CSL Limited (Afluria);
  • GlaxoSmithKline Biologicals (Fluarix);
  • ID Biomedical Corp. (FluLaval);
  • MedImmune Vaccines Inc. (FluMist);
  • Novartis Vaccines and Diagnostics Limited (Fluvirin); and
  • Sanofi-Pasteur (Fluzone High-Dose and Fluzone Intradermal).

Go to www.cdc.gov/flu or www.flu.gov for more information on influenza.