Flublok is the world’s first recombinant protein based influenza vaccine. Although we use modern technology to produce Flublok, its development did not happen overnight. By the time we applied for approval of Flublok from the U.S. Food and Drug Administration (FDA) in 2008, we had completed a total of 13 clinical studies in adults to demonstrate that Flublok is safe and effective. The first 9 studies were conducted in collaboration with the National Institutes of Health (NIH). These studies primarily tested formulations with either one or two hemagglutinin components, rather than the three components in the licensed Flublok. We conducted four studies that tested the safety and effectiveness of the trivalent Flublok formulation. This is the formulation of the licensed vaccine.
Following our initial license application in 2008, we entered a long phase of pre-approval inspections, answering questions from FDA, and completing multiple regulatory submissions to FDA. On January 16, 2013, Flublok was approved by FDA for adults 18-49 years old. Since then, several other major milestones have been achieved:
Throughout its history, Flublok has been recognized as an innovative vaccine, most recently being recognized by the Connecticut Economic Review as the first recombinant influenza vaccine, alongside other Connecticut firsts such as the helicopter, the 33 1/3 LP record, and the first nuclear submarine.
Flublok innovation will not stop here. We are continuing to improve our vaccine by expanding to a quadrivalent formulation containing recombinant hemagglutinin from 4 influenza strains, developing alternative methods of administering the vaccine to eliminate the traditional syringe and needle, and developing a formulation that does not require refrigeration.