FDA Approves New Influenza Vaccine Manufactured with Novel Technology - Pharmaceutical Technology

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FDA Approves New Influenza Vaccine Manufactured with Novel Technology


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has approved Protein Sciences’s FluBlok, a seasonal influenza vaccine made with novel technology. FluBlok uses recombinant DNA and a modified baculovirus (a virus that infects insects) to produce a safe and effective human influenza vaccine. FDA approved FluBlok for people 18–49 years old.

“This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, in a Jan. 16, 2013, FDA press release. “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.”

According to a press release, Flublok is an influenza vaccine made without the use of live influenza virus and it’s an egg-free influenza vaccine. In addition, it contains highly purified properties without preservatives (thimerosal), antibiotics, or adjuvants; and three times the active ingredient of that in traditional influenza vaccines.

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