Filter News

Protein Sciences Corporation Release: 2016/17 Formulation Of Flublok Influenza Vaccine Receives FDA Approval

Published: Jul 12, 2016

MERIDEN, Conn., July 12, 2016 /PRNewswire/ -- Protein Sciences Corporation announced that FDA has approved the 2016/17 formulation of Flublok® influenza vaccine.   Unlike other vaccines, all flu vaccines are adjusted annually to protect against the new strains of influenza that are predicted to be the dominant circulating strains during the upcoming fall and winter.  This year FDA mandated two new components be made for trivalent flu vaccines, including a new H3N2 component that is also required for quadrivalent vaccines.  H3N2 vaccine components are historically the most challenging for egg-based flu vaccine manufacturers to make and are the components that have been linked to poor vaccine efficacy in the past.  In contrast, Protein Sciences' technology platform for making Flublok allows for a perfect match to H3N2 strains.  In a post-marketing clinical study of 9,000 adults 50 years and older during the 2014/15 flu season where H3N2 influenza was dominant, people who received Flublok were over 40% less likely to get cell culture confirmed influenza than people who received an egg-based flu vaccine.  FDA approval of the 2016/17 formulation of Flublok means that Flublok is on track to ship to healthcare providers in early August.     

Protein Sciences Corporation is saving lives and improving health through the creation of innovative vaccines and biopharmaceuticals

"The timing of this approval could not be better. We will be able distribute Flublok earlier this season than before," said Manon Cox, President and CEO of Protein Sciences Corporation. "In a surprise turn of events, CDC recently recommended against the use of FluMist® (LAIV) vaccine that will result in a significant shortage of flu vaccines this season. Flublok is an excellent alternative for adults 18 and older.  Flublok's game-changing technology produces a highly pure and effective vaccine that has broad consumer appeal." 

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:

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-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 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.

Logo - http://photos.prnewswire.com/prnh/20140617/118909

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/201617-formulation-of-flublok-influenza-vaccine-receives-fda-approval-300297283.html

SOURCE Protein Sciences Corporation

Back to news