MERIDEN, Conn., April 4, 2017 /PRNewswire/ -- Protein Sciences Corporation, maker of Flublok® Influenza Vaccine, announced that FDA approved an extended shelf life for Flublok Quadrivalent from 6 months to 9 months ensuring that Flublok can be used throughout the flu season. Trivalent Flublok was introduced to the market 4 years ago. Flublok Quadrivalent will be available in prefilled syringes during the upcoming flu season. Any licensed physician can order the product directly from Protein Sciences or from one of the distributors listed below. Locations carrying the vaccine will be added to the company's Flublok Finder on a daily basis starting in August to help people find a location near them.
Flublok Quadrivalent protects against four strains of the influenza virus and has 3x more active ingredients than other quadrivalent flu vaccines, making it the only high-antigen quadrivalent vaccine on the market and a great option for seniors. Flublok Quadrivalent demonstrated better efficacy compared to a standard quadrivalent flu vaccine in adults 50 and older in a large clinical study, with recipients of Flublok being 43% less likely to get culture-confirmed influenza than those that received the standard vaccine.
"Flublok Quadrivalent is a remarkable vaccine," said Manon Cox, President and CEO of Protein Sciences Corporation. "Protection against more strains, better efficacy, extreme purity, and high antigen content are only a few benefits that differentiate Flublok Quadrivalent from the competition. FDA's approval of a 9-month shelf life positions Flublok Quadrivalent as one of the leading vaccines on the market." She added, "We expect to receive approval for a one year shelf life for both formulations of Flublok in the near future."
Pre-booking for Flublok Quadrivalent is underway. Shipping is expected to begin in August.
About Protein Sciences
Protein Sciences is a world leader 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, is approved for all adults over 18 years. FDA approved the quadrivalent formulation ("Flublok Quadrivalent") in October 2016 that will be commercially available for everyone over 18 years for the 2017/18 influenza season. 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, antibiotics or harsh chemicals (e.g., formaldehyde) in manufacturing. Flublok is highly purified and does not contain any preservatives (e.g., thimerosal - a form of mercury), egg proteins, gelatin or latex. In addition, Flublok contains three times more antigen than traditional flu vaccines (3x45mcg hemagglutinin protein versus 3x15mcg hemagglutinin protein).* In a 2014/15 post-marketing study of 9,000 adults 50 years and older, people who received Flublok were over 40% less likely to develop cell culture confirmed influenza than people who received a traditional flu vaccine. Flublok is an exact copy of the influenza virus coat protein 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 in the U.S. wishing to order Flublok should contact one of the following distributors:
- Protein Sciences Corporation: 203-686-0800 www.flublok.com
- FFF Enterprises: 800-843-7477 www.myfluvaccine.com
- Cardinal Health: 866-677-4844 http://www.cardinal.com/flu
- McKesson: 877-MCK-4FLU mms.mckesson.com
- Moore Medical: 800-234-1464 www.mooremedical.com/flu
- Henry Schein: 1-800-772-4346 www.henryschein.com
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. 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 in two field trials in adults ≥50 years old. The B strain antibody responses were comparable to traditional trivalent and quadrivalent vaccines.
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SOURCE Protein Sciences Corporation