FDA approves new flu vaccine

10:58 AM, Jan 17, 2013   |    comments
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WASHINGTON - Health officials now have a second weapon in their arsenal in the battle to fight the flu bug.

The U.S. Food and Drug Administration (FDA) announced Thursday that it has approved Flublok, what the agency calls the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.

We'll try to explain that in more understandable terms.

Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.

The FDA says unlike current flu vaccines, Flublok does not use the influenza virus or eggs in its production. Flublok's unique 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 contains three, full-length, recombinant HA proteins to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain.

As it does with all influenza vaccines, the FDA will evaluate Flublok annually prior to use by the public each flu season. The recombinant HA proteins produced in the baculovirus expression system and included in Flublok will be assessed by the FDA.

Flublok's safety evaluation was conducted in a study of about 2,500 people who were vaccinated with Flublok. The most commonly reported adverse events included pain at the site of injection, headache, fatigue and muscle aches, events also typical for conventional egg-based, inactivated influenza vaccines.  

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