U.S. Biomedical Advanced Research and Development Authority (BARDA) Extends Contract with Protein Sciences Corporation
MERIDEN, Conn., June 17, 2014 /PRNewswire/ -- Protein Sciences Corporation announced today that BARDA, within the U.S. Department of Health and Human Services, exercised Option Period 2 of its contract with the Company (contract number HHS0100200900106C) to support development, scale-up and expanded licensure of the Company's influenza vaccines, Flublok® (seasonal) and Panblok® (pandemic). Option Period 2 has a budget of $50.6 million and will run through December 31, 2015. The total value of the contract, originally awarded in 2009, is $146.9 million.
BARDA funds supported the initial licensure of Flublok, the world's first recombinant influenza vaccine, which was approved by FDA in January 2013. The recombinant technology used to make Flublok and Panblok is the pandemic solution; these vaccines can be made safely, accurately and much faster than they could by using other technologies. The Option Period 2 funds will support licensure of Protein Sciences' newly acquired larger-scale manufacturing facility in Pearl River, New York that manufactures Flublok and is planned to have the capacity to produce 50 million doses of Panblok within 6 months of declaration of a pandemic as required by the BARDA contract. The funds will also be used for clinical studies to support licensure of Panblok and a quadrivalent formulation of Flublok.
Manon Cox, President and CEO of Protein Sciences said, "We are fortunate to have been able to build a strong partnership with BARDA." She added, "An analysis of past pandemics revealed that vaccines were available too late and in short supply. Recombinant technology such as that used to make Flublok and Panblok ensures abundant vaccines with the correct sequence are available when they are needed."
About Protein Sciences
Protein Sciences is a vaccine development and protein production company that is dedicated to saving lives and improving 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 approved by FDA in January 2013. 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 or antibiotics in manufacturing. Flublok is highly purified and does not contain any preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex. In addition, Flublok is triple the strength of conventional influenza vaccines. Flublok is a perfect 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). We have filed for FDA approval of Flublok for ages 50 and above and expect to receive approval in time for the 2014/15 influenza season.
Healthcare professionals can order Flublok by contacting FFF Enterprises at 800-843-7477 or ASD Specialty Healthcare at 866-281-4FLU.
Flublok Safety Information
Flublok is approved for people 18-49 years old to prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Other side effects may occur and include fatigue, headache and muscle aches.
Flublok should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component.
Tell the doctor if you have ever experienced Guillain-Barré syndrome (severe muscle weakness) within 6 weeks of receipt of a previous dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact your healthcare professional immediately. Vaccination with Flublok may not protect all individuals.
SOURCE Protein Sciences Corporation