Protein Sciences: FDA approves 2016/17 formulation of Flublok

MERIDEN, Conn. - Protein Sciences Corporation on Tuesday announced that FDA has approved the 2016/17 formulation of Flublok influenza vaccine.   

FDA approval of the 2016/17 formulation of Flublok means that Flublok is on track to ship to healthcare providers in early August.     

"The timing of this approval could not be better. We will be able distribute Flublok earlier this season than before," stated Manon Cox, president and CEO of Protein Sciences Corporation. "In a surprise turn of events, CDC recently recommended against the use of FluMist vaccine that will result in a significant shortage of flu vaccines this season. Flublok is an excellent alternative for adults 18 and older."

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.  

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, Protein Sciences reported.