FDA Approves Vaccines for the 2010-2011 Influenza Season

August 12, 2010

The US Food and Drug Administration has approved vaccines for the 2010?2011 influenza season in the United States.

The US Food and Drug Administration has approved vaccines for the 2010–2011 influenza season in the United States.

Seasonal influenza vaccine protects against three strains of influenza, including the 2009 H1N1 influenza virus, which caused the 2009 pandemic. Last year, because the 2009 H1N1 virus emerged after production began on the seasonal vaccine, two separate vaccines were needed to protect against seasonal flu and the 2009 H1N1 pandemic flu virus, but this year only one vaccine is necessary.

The brand names and manufacturers for the upcoming season’s vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

Each year, experts from the FDA, World Health Organization, CDC, and other institutions study virus samples and patterns collected worldwide to identify strains likely to cause the most illness during the upcoming season.

Based on that information and the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, manufacturers included the respective three strains in the 2010–2011 vaccines. The closer the match is between the circulating strains and the strains in the vaccine, the better the protection against influenza disease.

Vaccines for the 2010–2011 seasonal influenza contain the following strains:

  • A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)

  • A/Perth /16/2009 (H3N2)-like virus

  • B/Brisbane/60/2008-like virus

The labeling for one vaccine, CSL Limited’s Afluria, has undergone changes this season to inform healthcare providers about an increased incidence of fever and febrile seizure, which was seen in young children, mainly those younger than 5 years, following administration of the 2010 Southern Hemisphere formulation of CSL’s influenza vaccine. CSL Limited will not be supplying the US with the 0.25-mL single-dose, prefilled syringes, which are used in very young children. The 0.5-mL single-dose, prefilled syringes and 5-mL multi-dose vials will be distributed. The FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere.