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U.S. FDA Approves Flublok®, The World's First Recombinant, Highly Purified, Egg-Free Influenza Vaccine

MERIDEN, Conn., Jan. 16, 2013 /PRNewswire/ -- 

  • The U.S. FDA approved Flublok for people 18-49 years old – making it the first recombinant vaccine for influenza available on the market. Approval for all people 18 years and above is expected later in 2013.
  • Flublok features:
    • First influenza vaccine made without the use of live influenza virus
    • First egg-free influenza vaccine
    • Highly purified without preservatives (thimerosal), antibiotics or adjuvants
    • Three times the active ingredient in traditional influenza vaccines
    • Manufactured in a fraction of the time required for traditional influenza vaccines

Protein Sciences Corporation announced today that the U.S. Food and Drug Administration (FDA) approved Flublok influenza vaccine for use in people 18-49 years old. 

Flublok is a novel protein vaccine for the prevention of seasonal influenza disease and is the first to be made in a 100% egg-free system without growing influenza viruses – so the vaccine can be made quickly and without any of the infectious risk traditionally associated with vaccine manufacture.  Flublok is highly purified, has three times the amount of active ingredient in traditional influenza vaccines, and contains no preservatives (thimerosal), antibiotics or adjuvants.

"Flublok is truly a modern vaccine," said Manon Cox, CEO of Protein Sciences.  She explained, "We use advanced scientific technology to make just the active ingredient of the vaccine without any other viral components.  This is the first influenza vaccine on the market to do so." 

Flublok and its sister vaccine, Panblok®, that is designed to protect against pandemic influenza, have been developed in partnership with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, through Contract No. HHS0100200900106C that was awarded in 2009.  Early clinical development of Flublok and Panblok was supported by generous grants from the National Institutes of Health through the Vaccine Treatment and Evaluation Units. 

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