FDA Approves Flublok Flu Vaccine
January 17, 2013

New Flu Vaccine Wins Regulatory Approval

Lee Rannals for redOrbit.com — Your Universe Online

A new flu vaccine won regulatory approval on Wednesday and its limited supplies are expected to be available this winter.

Protein Sciences won the approval for Flublok, which is made with a process that does not require the virus to be grown in chicken eggs.

“This approval represents a technological advance in the manufacturing of an influenza vaccine,” Dr. Karen Midthun, a senior official at the U.S. Food and Drug Administration, said in a statement.

The approval comes during one of the more severe flu seasons, 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 available for distribution later on during the flu season.

This small amount of dosage could still be particularly helpful for those who do not get flu shots because they are allergic to eggs.

An FDA spokeswoman said the timing of the approval was unrelated to the current flu season, which is moving at a rapid pace.

Flublok consists of only a protein from the virus. This protein is made by putting the gene for it into a virus that infects insect cells. Those cells are grown in a culture and churn out the protein. Neither eggs nor the live virus are used, though viral genetic information is needed.

These protein-based vaccines have been used to prevent other diseases in the past, but are new to a flu vaccine.

Protein Sciences applied for approval of Flublok nearly five years ago, and it was turned down twice due to 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,” Cox told the New York Times.

Flublok is approved for adults 18 to 49 years old, and it was about 44.6 percent effective against all influenza strains, not just the three contained in the vaccine.

Cox told MedPage Today the FDA recently informed the company it would like to see more safety data in people older than 55. She said she expects approval to expand to older adults by the end of the year.