The U.S. Food and Drug Administration has approved Flublok, the flu vaccine made by Protein Sciences Corp., setting the stage for the Meriden-based company to launch large-scale manufacture of the first-ever flu vaccine that’s not made from cultured eggs.
The approval allows Protein Sciences to sell the vaccine for people ages 18 to 49. Anticipating the decision, Protein Sciences is setting up manufacturing space in Pearl River, N.Y., which was previously used by Wyeth and was closed after that company was bought by Pfizer in 2009.
Final approval is a major landmark for Protein Sciences, which began early clinical trials in 1993. The potential, said Dan Adams, the executive chairman, is huge.
“Next year we’re looking to sell three to five million doses,” he said, at prices higher than traditional flu vaccines.
Flublok is made using recombinant DNA and an insect virus, with the advantage that it doesn’t require time-consuming egg cultures that are easily contaminated. “The vaccine can be made quickly and without any of the infectious risk traditionally associated with vaccine manufacture,” the company said in its announcement.
Approval came at the end of business hours Wednesday, and although it was expected, “You don’t know until you get it,” Adams said.
Protein Sciences completed development of Flublok and a related vaccine aimed at pandemic flu outbreaks in collaboration with the U.S. Department of Health and Human Services.
On Thursday, Assistant Secretary Nicole Lurie issued a statement saying the approval “stands as one of the most significant improvements in flu vaccine technology in the past 50 years.”
“The process is nimble enough to be used for seasonal as well as potentially for pandemic flu vaccine because the technology does not depend on an egg supply or on the availability of modified influenza virus for production like traditional egg-based vaccine manufacturing does,” Lurie said in the release.
Protein Sciences was founded in 1983 as MicroGeneSys Inc., and was the first firm to test an AIDS vaccine — but that drug did not reach the market. Approval of Flublok was originally expected as early as 2008, but the company lost three years, Adams said Thursday, fighting off a takeover deal from Emergent BioSolutions Inc. that soured and became hostile.
Approval comes in a year when the flu epidemic is especially severe in the United States, and is still worsening in Connecticut, according to a state report Thursday.
Some Flublok manufacturing will be in Meriden, where Protein Sciences recently expanded to a second building, and Adams said last month that the company could expand further at its home location — although the Pearl River complex has room for significant growth.