Flublok, new influenza vaccine made using baculovirus receives FDA approval
The first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology, Flublok, received U.S. Food and Drug Administration (FDA) approval Wednesday for the prevention of seasonal influenza in people 18 through 49 years of age, according to a FDA press release Jan. 16.
Flublok contains three, full-length, recombinant hemagglutinin (HA) proteins to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain.
Flublok does not use the influenza virus or eggs in its production unlike current flu vaccines on the market, instead Flublok’s novel manufacturing technology allows for production of large quantities of the influenza virus protein, hemagglutinin (HA) – the active ingredient in all inactivated influenza vaccines that is essential for entry of the virus into cells in the body. The majority of antibodies that prevent influenza virus infection are directed against HA.
While the technology is new to flu vaccine production, it is used to make vaccines that have been approved by the FDA to prevent other infectious diseases.
“This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Karen Midthun, M.D., 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.”
Flublok is manufactured by Protein Sciences Corp, of Meriden, Conn.
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