MERIDEN, Conn., Sept. 7, 2016 /PRNewswire/ -- Protein Sciences Corporation announced today that the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, has awarded the Company a contract that is part of the Authority's medical countermeasures against pandemic influenza and influenza strains with pandemic potential (contract number HHSO100201600005I). Protein Sciences will perform the contract using its proprietary platform technology for producing vaccines that according to the Food and Drug Administration has revolutionized influenza vaccine manufacturing and stands to receive up to $610 million through 2021 if BARDA exercises all options. The Company's Flublok® (seasonal) and Panblok® (pandemic) influenza vaccines can be made with unprecedented speed, safety and precision. The new contract with BARDA taps into this technology and ensures the Country will be prepared with sufficient supplies of vaccine in a timely manner should an influenza pandemic strike. The contract will finance preparation of starting materials for multiple potential pandemics that could shave a month or more off the time when the Company will have a vaccine available.
Protein Sciences President and CEO Dr. Manon Cox said, "We are very pleased to extend our relationship with BARDA and support them in their mission to provide 'More, Faster, Better' vaccines in the face of a pandemic." She added, "Prior support from BARDA was critical in the development and scale-up of our technology, which is now the only platform that is used to manufacture an FDA-approved vaccine (i.e., Flublok) and can address a pandemic in time."
About Protein Sciences
Protein Sciences specializes in vaccine development and protein production. Our mission is our inspiration: to save lives and improve health through the creation of innovative vaccines and biopharmaceuticals.
Flublok, the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease, was initially approved by the U.S. FDA in January 2013. FDA expanded its approval in October 2014 to include everyone over 18 years and approved a nine month shelf life in June 2016. Flublok is also licensed for sale in Mexico and licensure in additional countries, including Japan, is expected in the near future. Flublok is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus, antibiotics or harsh chemicals in manufacturing. Flublok is highly purified and does not contain any preservatives (e.g., thimerosal, which contains mercury), egg proteins, gelatin or latex. In addition, Flublok contains three times more antigen than traditional flu vaccines (3x45mcg hemagglutinin protein versus 3x15mcg hemagglutinin protein) and was shown to have superior efficacy in a 2014/15 post-marketing study.* Flublok is an accurate copy of the virus coat and is not subject to the egg-adapted mutations associated with low vaccine effectiveness (see Skowronski et al. (2014) PLOS ONE 9(3), e92153).
Healthcare professionals wishing to order Flublok should contact one of the following distributors:
- Protein Sciences Corporation: 203-686-0800 www.flublok.com
- FFF Enterprises: 800-843-7477 www.myfluvaccine.com
- Cardinal Health: 866-677-4844 http://www.cardinal.com/us/en/SPD/Ordering
- McKesson: 877-MCK-4FLU mms.mckesson.com
- Moore Medical: 800-234-1464 www.mooremedical.com/flu
- Henry Schein: 1-800-772-4346 www.henryschein.com
Flublok Safety Information
Flublok is approved for people 18 and older to prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Headache, fatigue or muscle ache may occur.
Tell the doctor if you have ever experienced Guillain-Barré syndrome (severe muscle weakness) or have had a severe allergic reaction to any component of Flublok vaccine.
Vaccination with Flublok may not protect all individuals. Clinical effectiveness in adults 50 and older is based on the immune response elicited by Flublok and not on demonstration of decreased influenza disease.
Please see the complete Package Insert available at www.flublok.com or call 203-686-0800 for more information.
*Flublok demonstrated a higher antibody response to the A strains in two field trials in adults ≥50 years old. The B strain antibody responses were comparable to traditional trivalent and quadrivalent vaccines.
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SOURCE Protein Sciences Corporation