U.S. FDA Approves Flublok®, the World's First Recombinant, Highly Purified, Egg-Free Influenza Vaccine
- 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:
o First influenza vaccine made without the use of live influenza virus
o First egg-free influenza vaccine
o Highly purified without preservatives (thimerosal), antibiotics or adjuvants
o Three times the active ingredient in traditional influenza vaccines
o Manufactured in a fraction of the time required for traditional influenza vaccines
Meriden, CT—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.
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 information.
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.
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.
For Immediate Release Contact:
January 16, 2013 Manon Cox, President & CEO
Phone: (203) 686-0800 ext. 308