Flublok for 2016/17 Influenza Season Approved
The FDA required two new components be made for trivalent flu vaccines this year, including a a new H3N2 component that is also mandated for quadrivalent vaccines. The H3N2 vaccine components are known to be the most difficult for egg-based flu vaccine manufacturers to create and have been previously associated with poor vaccine efficacy.
A post-marketing clinical study (n=9,000) of adults aged ≥50 years during the 2014/15 flu season where H3N2 influenza was dominant showed that those who received Flublok were >40% less likely to get cell culture confirmed influenza vs. those who received an egg-based flu vaccine.
Flublok, the first recombinant protein-based vaccine to prevent seasonal influenza, was initially approved by the FDA in January 2013. Flublok contains three times more antigen (3x45mcg hemagglutinin protein) than traditional flu vaccines (3x15mcg hemagglutinin protein). It is made in a 100% egg-free system and does not require the use of an infectious influenza virus or antibiotics for manufacturing. It is highly purified and does not contain any preservatives, egg proteins, gelatin or latex.
The 2016/17 formulation of Flublok will begin shipment in early August.
For more information call (203) 686-0800 or visit Flublok.com.