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FDA Approves New Seasonal Influenza Vaccine Made Using Novel Technology

Source: FDA News Release

01/16/2013

The Food and Drug Administration (FDA) has approved Protein Sciences Corp.’s Flublok, the first trivalent flu vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. The vaccine—approved for the prevention of seasonal flu in individuals ages 18 through 49 years—contains three, full-length, recombinant hemagluttinin (HA) proteins to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain. The novel manufacturing system allows for production of large quantities of HA without using the influenza virus or eggs, as current flu vaccines do. “This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”



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