MERIDEN, Conn., Oct. 29, 2014 /PRNewswire/ -- Protein Sciences Corporation announced today that the U.S. FDA has approved Flublok influenza vaccine for all adults aged 18 years and older, granting approval for use in people 50 and older under the accelerated approval of biological products regulations, 21 CFR 601.40-46. Flublok is the only licensed flu vaccine that is made using modern recombinant technology and the only flu vaccine that is 100% egg-free and highly purified. It also contains three times more active ingredients than traditional flu vaccines. The expanded age indication means Flublok is now available for everyone over 50 who have been waiting patiently to receive his or her vaccine.
Lisa Dunkle, MD, Chief Medical Officer of Protein Sciences said, "Older adults are known to be at high risk for contracting and developing complications from influenza." She continued, "Flublok has been shown to induce high antibody levels in seniors."
"We are excited with this approval," said Dr. Manon Cox, MBA, President and CEO of Protein Sciences. "We set out to develop a better vaccine for the older population by increasing the amount of active ingredients in the vaccine. People of all ages have been calling and asking for Flublok and now it is terrific to be able to (finally) tell them that the product is approved for all adults. Flublok is a modern vaccine with particular benefits to individuals who want (need) to avoid exposure to egg proteins, gelatin, latex, formaldehyde or antibiotics as Flublok is free of all of these unnecessary and avoidable components."
Earlier this year the FDA approved a shelf life extension for Flublok to 6 months.
Flublok is available at Passport Health locations nationwide and select pharmacies, clinics and doctor's offices. A list of locations can be found at www.flublok.com.
Healthcare professionals seeking Flublok should contact FFF Enterprises at 800-843-7477 or online at www.myfluvaccine.com. FFF Enterprises will begin shipment immediately or delivery dates can be specified.
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 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 contains three times more antigen than traditional flu vaccines (3x45mcg hemagglutinin protein versus 3x15mcg hemagglutinin protein). 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).
Healthcare professionals can order Flublok by contacting FFF Enterprises at 800-843-7477.
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-Barre 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.
SOURCE Protein Sciences Corporation