Protein Sciences announced that the FDA has approved the strain change amendment for its 2014/15 seasonal influenza vaccine, Flublok (trivalent, recombinant hemagglutinin [virus types A and B]). Each year, manufacturers of the influenza vaccine are required to receive approval from the FDA before making changes to the upcoming season’s manufacturing process and product formulation.
Flublok is the first recombinant protein-based vaccine for the prevention of seasonal influenza disease, and is the only flu vaccine made in a 100% egg-free system. It is highly purified and does not contain any preservatives, egg proteins, gelatin or latex.
Flublok is currently indicated for active immunization against influenza virus subtypes A and B in persons 18–49 years of age. Flublok is undergoing FDA review for use in patients aged >50, and is expected an approval in time for the 2014/15 influenza season.
Flublok is supplied as 0.5mL single-dose vials in 10-count cartons. This approval will allow for timely delivery to healthcare providers in the fall.
For more information call (203) 686-0800 or visit Flublok.com.