The FDA's Vaccines and Related Biological Products Advisory Committee today will determine whether Protein Sciences' flu vaccine FluBlok, which can be produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells, warrants approval.
FluBlok can be produced in a third of the time it takes larger drugmakers, including Sanofi-Aventis, GlaxoSmithKline and Novartis, to make their chicken egg-based shots, according to a Bloomberg article. If approved, FluBlok would represent the first cell-culture derived influenza vaccine licensed in the U.S., according to FDA briefing documents posted ahead of the committee meeting.
FDA documents also revealed that the vaccine was as safe and effective as other shots. The agency made this assessment based on data from four studies of 3,231 adults.
Protein Sciences has grown to 63 employees from 40 in the last three months, and if the vaccine is approved, it may be the smallest company to receive an FDA drug approval, Daniel Adams, Protein Science's CEO, tells Bloomberg. The company may have shots ready for next flu season, he adds.