The U.S. Food and Drug Administration said it approved Flublok, described as the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age. The FDA announcement noted that unlike current flu vaccines, Flublok does not use the influenza virus or eggs in its production. 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. Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “This approval represents a technological advance in the manufacturing of an influenza vaccine. 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.”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm335891.htm