Five years after little Protein Sciences first went to the FDA in search of an approval of its innovative flu vaccine, regulators have finally agreed to hit the green light to permit the biotech to start marketing the jab. The FDA agreed that Flublok offers the kind of novel technological breakthrough that can provide a relatively quick source of vaccines to fight a pandemic. And the company says it plans to start offering a small supply of the vaccine to guard against the ongoing seasonal epidemic that has rattled health officials from coast to coast.
Protein Sciences' big idea was to insert the gene for hemagluttin into a virus that would then be used to infect insect cells. That process can shave weeks off of the standard, decades-old approach to developing vaccines, which involves using a flu virus and chicken eggs.
"This approval represents a technological advance in the manufacturing of an influenza vaccine," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. "The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus."
It's by no means a perfect anti-flu weapon, though. The New York Times notes that in a clinical trial Flublok was only 44.6% effective--but it worked against all flu strains, rather than the select few included in each year's seasonal stockpile.
"It's just inherently faster since you don't have to use a live flu virus," Protein Sciences Executive Chairman Daniel Adams told FierceVaccines. "You don't have to use a live flu virus. You don't have to worry about safety. There's no safety issue with the genetic code."
The approval marks the end of a long and often perilous development quest for Protein Sciences, which had to fight a nasty lawsuit after breaking up with another company that had agreed to buy the biotech in 2008. Forced to navigate around bankruptcy, Protein Sciences won key support from the government, which has been trying to foster new flu vaccine technologies following the snafu over the swine flu outbreak a few years ago.
- here's the release from the FDA
- read the FierceVaccines story
- get the report from The New York Times (sub. req.)
Special Report: Major FDA vaccine approvals of 2012