The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is an advisory panel with the United States Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). The committee includes 12 members and a voting chairman, all selected by the FDA Commissioner or designee. The VRBPAC is charged with review and evaluation of data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products. These are typically those products which are intended for use in prevention, treatment and/or diagnosis of human disease. When required, the committee may review any other product for which the FDA has regulatory responsibility.
On February 23, 2010, the committee voted unanimously to recommend that the 2010-2011 seasonal influenza vaccine include a strain of the pandemic A (H1N1) virus. This would be in addition to 2 other viral strains. At the present, the vaccine for pandemic A (H1N1) is being administered in monovalent form while an additional trivalent vaccine is administered for seasonal influenza.
For the 2010-2011 influenza season, a strain of the pandemic A (H1N1) virus would replace a non-pandemic A (H1N1) strain in the trivalent vaccine. Including the pandemic A (H1N1) virus in a trivalent vaccine “cocktail” would eliminate the need to administer 2 separate vaccines. Additionally, manufacturers would not have to produce 2 separate vaccines, which was a contributing cause of production delays in 2009.
The advisory panel’s recommendation is based on the assumption that the pandemic A (H1N1) virus will continue to be the dominant strain in circulation. This is the same assumption made by the World Health Organization (WHO). Last week, WHO recommended that the 2010-2011 seasonal influenza vaccine for the northern hemisphere include a strain of the pandemic A (H1N1) virus, along with 2 non-pandemic viruses. WHO recommended the same vaccine “recipe” in September 2009 for use in the southern hemisphere's 2010 influenza season.