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New Four-Strain Flu Vaccine Accepted for FDA Review

Action date expected in second quarter, 2013 (Oct. 18)

The FDA has accepted a Supplemental Biologics License Application (sBLA) for a new quadrivalent formulation of Fluzone influenza virus vaccine (Sanofi Pasteur). An action date is expected in the second quarter of 2013.

The strains for each season's influenza vaccine are selected by the FDA, in consultation with global health authorities, from the strains anticipated to circulate in the approaching influenza season. Seasonal influenza vaccines contained only two strains (one strain of type-A influenza and one strain of type-B influenza) until 1978, when the decision was made to incorporate a second type-A influenza strain in order to provide protection against the two different A strains that were co-circulating. From then until now, influenza vaccines have been trivalent to help protect against three stains of influenza virus (two of type A and one of type B).

However, since the influenza B Victoria lineage re-emerged worldwide in 2001–2002, two influenza B strains (one each from the Victoria and Yamagata lineages) have co-circulated with varying prevalence, making it difficult to predict the next season's dominant B strain. Even in years where the correct B virus strain was selected for the vaccine, some influenza disease was caused by the B strain omitted from the vaccine. These factors raised the hypothesis that the addition of a second B-lineage strain to expand the licensed trivalent influenza vaccine to a quadrivalent vaccine could help reduce influenza disease and the frequent complications that occur, often resulting in preventable hospitalizations or even deaths.

Sanofi Pasteur, the manufacturer of the new quadrivalent vaccine, is seeking FDA licensure for active immunization of children and adults 6 months of age and older for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. This is the same age indication for the company’s currently licensed trivalent Fluzone vaccine.

Fluzone is the only influenza vaccine licensed in the U.S. for children as young as 6 months of age.

Source: Sanofi Pasteur, October 18, 2012.

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