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

Wed Jan 16, 2013 6:26pm EST

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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

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

"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.   

Flublok will be widely available for the 2013-2014 influenza season and is
available in limited supply for the current season.  Additional information
about Flublok including patient information and announcements regarding where to
get the vaccine can be found at  www.flublok.com.  Please refer to the complete
Flublok package insert available on the website for full prescribing

Flublok is a trivalent composition of recombinant influenza hemagglutinin (rHA)
proteins that are manufactured using Protein Sciences' proprietary baculovirus
expression vector system (BEVS) technology and  expresSF+ cell line.   

About Us

Protein Sciences Corporation is a vaccine development and protein production
company based in  Meriden, CT  that is dedicated to saving lives and improving
health through the creation of innovative vaccines and biopharmaceu­ticals. Our
proprietary BEVS technology provides a fast, reliable and inexpensive platform
for the production of high quality recombinant proteins, making it a powerful
tool for producing vaccines and therapeutics when they are needed most.  BEVS
technology is covered by broad patents that include our proprietary  expresSF+
cell line that we use to make all of our products.

We recently expanded to  Pearl River, NY  where we will manufacture Flublok in
addition to our  Meriden, CT  facility.

SOURCE  Protein Sciences Corporation

Manon Cox, President & CEO, +1-203-686-0800 ext. 308

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