TUESDAY, SEPTEMBER 27, 2016

FDA approves 2014-2015 formulation of Flublok influenza vaccine

Protein Sciences Corp. announced on Tuesday that the U.S. Food and Drug Administration approved the company's strain change amendment to Flublok, its seasonal influenza vaccine, for the 2014-2015 flu season.

Influenza vaccine manufacturers must receive approval from the FDA for any changes made to their manufacturing processes or product formulation. The early approval for Flublok will ensure that healthcare providers will receive the vaccine on time for the flu season in the fall.

"We anticipate having the first doses of Flublok available in September and the FDA's approval supports this timeline," Manon Cox, the president and CEO of Protein Sciences, said. "We are still accepting orders for the fall and providers are encouraged to order through our distributors FFF Enterprises and ASD Healthcare."

Flublok is an egg-free and highly pure vaccine that is triple the strength of conventional flu vaccines. The protein-based treatment was first approved by the FDA in 2013 and is the only egg-free system using modern cell culture technology.

Flubok is approved for people between 18-49 years of age. Protein Sciences also applied for FDA approval of Flublok for people ages 50 and above in anticipation of this year's flu season.

The most common side effect from Flublok is pain at the site of the injection.