FDA Panel: Add Two New Strains to 2012 Influenza Vaccine



SILVER SPRING, MD. – A Food and Drug Administration advisory panel on Feb. 28 recommended that the vaccine for the next influenza season should include two new strains and retain only one of the three strains in the current vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 18-0 that the 2012-2013 seasonal flu vaccine used in the United States should include the same influenza A (H1N1) component included in the 2011-2012 vaccine, an A/California/7/2009 (H1N1)-like virus. For the second influenza A strain in the vaccine, the panel’s vote was also unanimous, recommending that the influenza A (H3N2) component be replaced with an A/Victoria/361/2011 (H3N2)-like virus.

The panel voted 17-1 that that the influenza B strain be replaced with a B/Wisconsin/1/2010-like virus (B/Yamagata lineage). The current vaccine strain is a B/Brisbane/60/2008-like virus, a B/Victoria lineage strain. Panelists pointed out, however, that determining which B strain to select, a Victoria or Yamagata lineage B strain virus, is always challenging and said that this illustrated the utility of a quadrivalent influenza vaccine that contains B/Victoria lineage and B/Yamagata lineage viruses.

It appears that a quadrivalent influenza vaccine may soon be available, possibly as early as 2013. At the meeting, representatives of several vaccine manufacturers provided updates on the status of their quadrivalent influenza vaccines in development, including GlaxoSmithKline, which has filed for FDA approval of a quadrivalent influenza vaccine for people aged 3 and older.

The FDA panel’s recommendations are the same as the World Health Organization’s recommendations for the 2012-2013 Northern Hemisphere seasonal influenza vaccine, made at a meeting earlier in February.

The FDA panel meets at this time every year to recommend the strains to be included in the trivalent influenza vaccine in the United States in the upcoming season, considering information on the strains circulating worldwide and the WHO recommendation for the vaccine to be used in the Northern Hemisphere.

This influenza season has started late, in February, and flu activity has been low, although it is expected to increase, the Centers for Disease Control and Prevention announced last week.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

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