Protein Sciences Receives Approval from FDA for 2014/15 Formulation of Flublok® Influenza Vaccine
MERIDEN, Conn., July 8, 2014 /PRNewswire/ -- Protein Sciences Corporation announced today that the FDA has approved the Company's strain change amendment for its seasonal influenza vaccine, Flublok. Every year influenza vaccine manufacturers must receive approval from the Agency for changes they make to the upcoming season's manufacturing process and product formulation, as the influenza vaccine is adapted annually. Early approval for Flublok will enable delivery on time to healthcare providers in the fall. This is especially important for those that rely on Flublok's unique properties for protection from the flu; namely, that the vaccine is egg-free, highly pure and triple the strength compared to conventional influenza vaccines.
President and CEO of Protein Sciences, Manon Cox said, "We anticipate having the first doses of Flublok available in September and the FDA's approval supports this timeline." She added, "We are still accepting orders for the fall and providers are encouraged to order through our distributors FFF Enterprises and ASD Healthcare."
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-Barre 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