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FDA Approved Longer Shelf Life for the Game Changer, Flublok Influenza Vaccine

MERIDEN, Conn., June 23, 2016 /PRNewswire/ -- Protein Sciences Corporation announced today that FDA has extended the shelf life for Flublok, its game changing seasonal influenza vaccine, to 9 months from the date of manufacture- increasing the previous shelf life by 3 months. The longer shelf life will make it easier for healthcare providers and pharmacies to stock Flublok and vaccinate people throughout the influenza season, which in some years can last as long as April or May.

"We are pleased to add an extended shelf life to the list of product improvements we have been able to achieve for Flublok," said Dr. Penny Post, Protein Sciences Vice President, Regulatory Affairs. "We were first able to expand the approved age range for Flublok to everyone 18 years and older in October 2014. In addition to the 9 month shelf life we just achieved, Flublok Quadrivalent is under review and FDA approval is anticipated this fall. We are working towards securing a one year shelf life as well."

In addition to Flublok's undeniable purity due to the absence of many ingredients that make traditional flu vaccines objectionable to some like mercury, antibiotics, or formalin, Flublok is highly effective. In a clinical study of approximately 9,000 adults 50 years and older, Flublok proved to be 43% more effective than a traditional egg-based flu vaccine in protecting people against cell culture confirmed influenza. Therefore, Flublok is a high efficacy vaccine for the entire adult population.

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).

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 during 2 clinical trials in adults ≥50 years old. The B strain antibody response was comparable to traditional trivalent vaccines.

SOURCE Protein Sciences Corporation

Posted: June 2016

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Flublok (influenza vaccine) FDA Approval History

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