New Flu Vaccine, Flubok, Approved by FDA

The US regulatory agency, the Food and Drug Administration (FDA), has given the green light to Protein Sciences Corp’s Flublok.

The vaccine will be the first trivalent influenza injection made using an insect virus expression system and recombinant DNA technology.

Unlike existing vaccines, Flublok does not use the flu virus or eggs; this is due to the fact that Protein Sciences’ manufacturing technology allows for production of large quantities of the protein hemagglutinin.  The protein is the active ingredient in all inactivated influenza vaccines that is crucial for entry of the virus into cells in the body.

Karen Midthun, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, noted that 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 recombinant proteins to help defend against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain.

The efficiency of the vaccine, which has been accepted for people aged 18-49, was assessed in a study that compared the use of Flublok in 2,300 volunteers to a placebo that was given to a control group of a comparable size.  Flublok was around 44.6% effective against all circulating influenza strains, not only those that matched the strains included in the vaccine.

Protein Sciences’ chief executive, Manon Cox, commented that Flublok is “truly a modern vaccine,” adding that “we use advanced scientific technology to make just the active ingredient…without any other viral components. This is the first influenza vaccine on the market to do so.”


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