A new type of flu vaccine won regulatory approval on Wednesday, and its manufacturer said that limited supplies are expected to be available this winter.
The vaccine, developed by a small company called Protein Sciences, is made with a process that does not require the virus to be grown in chicken eggs, as is now generally done. That means a vaccine could be ready weeks earlier in the event of a pandemic.
“This approval represents a technological advance in the manufacturing of an influenza vaccine,” Dr. Karen Midthun, a senior official at the Food and Drug Administration, said in a statement announcing the agency’s approval of the product, which is called Flublok.
The approval comes during one of the more severe flu seasons in recent years, with many Americans rushing to find diminishing supplies of vaccine and spot shortages being reported.
Manon Cox, the chief executive of Protein Sciences, said the company could have about 150,000 doses ready to distribute later this flu season. That is a relatively small amount, but it could be particularly helpful for people who do not get flu shots now because they are allergic to eggs.
A spokeswoman for the F.D.A. said the timing of the approval was unrelated to the current flu season.
Most flu vaccines are made by growing the virus in chicken eggs, then inactivating or killing it, a long process.
Flublok, by contrast, consists only of a protein — hemagglutinin — from the virus. The protein is made by putting the gene for hemagglutinin into a virus that infects insect cells. Those cells, from the fall armyworm, are grown in culture and churn out the protein. Neither eggs nor the live virus are used, though viral genetic information is needed.
While new for flu, such protein-based vaccines are used to prevent some other diseases.
Protein Sciences, a privately held company in Meriden, Conn., first applied for approval nearly five years ago. It was turned down twice, in part because of the novelty of using insect cells. “Every time we were asked to do more and more studies to prove that this cell substrate was safe,” Ms. Cox said.
The company was close to bankruptcy in 2009 when it received a federal contract worth tens of millions of dollars to help develop its vaccine.
The vaccine is approved only for adults 18 to 49 years old. In a clinical trial, Flublok was about 44.6 percent effective against all influenza strains, not just the three contained in the vaccine, the F.D.A. said. As with current vaccines, Flublok will need to change each year to match the flu strains in circulation.
Flublok, a Flu Vaccine, Wins F.D.A. Approval
This article
Flublok, a Flu Vaccine, Wins F.D.A. Approval
can be opened in url
https://sugarnewster.blogspot.com/2013/01/flublok-flu-vaccine-wins-fda-approval.html
Flublok, a Flu Vaccine, Wins F.D.A. Approval
