The FDA Approval of Flublok


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The FDA Approval of Flublok

On Jan. 16, 2013, the U.S. Food and Drug Administration (FDA) announced the approval of Flublok for the prevention of seasonal influenza in people aged from 18 to 49. Flublok is the first trivalent influenza vaccine that uses baculovirus expression system and novel recombinant DNA technology. The technology is a new thing for the flu vaccine production.

Different from common flu vaccines, Flublok abandons influenza virus or eggs in its production. Flublok’s novel manufacturing technology allows for the 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, and most of the antibodies that prevent influenza virus infection are directed against HA.

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. 

The Flublok effectiveness has been assessed in a study in about 2,300 people to a placebo that was given to a control group of similar size. In the result, it was about 44.6 percent effective against all circulating influenza strains.

The FDA expressed that they will re-review the Flublok like they did to any other vaccines some time.

Flublok has a shelf life of 16 weeks from the date of manufacture, produced by Protein Sciences Corp, of Meriden, Conn.

Article Link: The FDA Approval of Flublok

Tags: FDA Approval,  Flublok,  Influenza Vaccine,  Recombinant DNA,  Baculovirus Expression

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