Protein Sciences Receives Approval from FDA for 2015/16 Formulation of Flublok® Influenza Vaccine
MERIDEN, Conn., July 8, 2015 /PRNewswire/ -- Protein Sciences Corporation announced that the FDA has approved the composition of Flublok® influenza vaccine for the 2015/16 flu season. Every year, influenza vaccine manufacturers must receive approval from the FDA for changes they make to their vaccines so that the vaccines protect against the new strains of flu that are predicted to circulate next flu season. This year, there are two strain changes. Traditional (egg-based) vaccine manufacturers may experience vaccine production delays during years when there are two or more new strains of flu as traditional manufacturing technology is slow; this was the case in the spring for the Southern Hemisphere with influenza vaccine delivery delays of over a month. In contrast, the technology used to make Flublok is fast. This approval enables us to deliver Flublok to distributors and retailers in mid-August.
Early availability of Flublok is especially important for those that rely on Flublok's unique properties for protection from the flu; namely, that the vaccine is highly pure (including being egg-, antibiotic-, latex-, gelatin-, gluten- and preservative-free) and contains three times more active ingredients than traditional flu vaccines*. A recent clinical study of the quadrivalent version of Flublok in approximately 9,000 adults 50 years and older showed that Flublok recipients were 31% less likely to develop laboratory confirmed influenza than the people that received a traditional egg-based quadrivalent vaccine.
"We are extremely pleased with the early approval of the 2015/16 Flublok formulation," said Manon Cox, President and CEO of Protein Sciences Corporation. "We expect Flublok to be available in Target pharmacies and other retail chains before most other vaccines this year. Flublok is approved for use in everyone 18 years and older."
For more information about Flublok, please visit www.flublok.com.
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 wishing to pre-order Flublok should contact one of the following distributors:
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
Henry Schein Medical: 800-772-4346 www.henryschein.com/flu
Learn more at www.proteinsciences.com and www.flublok.com.
Flublok Safety Information
Trivalent 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 of trivalent Flublok in adults 50 and older is based on the immune response elicited by trivalent 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.
*Trivalent Flublok demonstrated a higher antibody response to the A strains during 2 clinical trials in adults >50 years old. The B strain antibody response was comparable to traditional trivalent vaccines.
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SOURCE Protein Sciences Corporation