MERIDAN, Conn. (WTNH) – The Federal Drug Administration just approved the 2016/17 formulation of the Flublok vaccine. Flu vaccines are adjusted annually to protect against the upcoming fall and winter.
“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.”
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.
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.