New vaccine approved for U.S. just in time for flu season

Aug 31 2005

A new flu vaccine has been approved by U.S. health officials in an attempt to bolster up supplies after last season's shortage.

It is hoped that the new vaccine, by GlaxoSmithKline will fill the void left after rival drug company Chiron Corporation lost its license, rendering it unable to deliver half the anticipated U.S. supply during the 2004-2005 flu season.

Health and Human Services Secretary Mike Leavitt says it is critical to public health that there are more manufacturers of influenza vaccine licensed in the U.S.

As the approval comes just weeks before the start of the 2005-2006 U.S. flu season, officials are hoping that last year's scramble for doses will not be repeated.

California-based Chiron's manufacturing license for its Fluvirin vaccine was withdrawn last October because of contamination at its factory in Liverpool, England.

This loss of an expected supply has led to early confusion and long waiting lists, while officials searched for alternative supplies.

Eventually 4 million doses from Glaxo were imported from around the world, and while certain U.S. regions were temporarily left without supplies, the season ended with a surplus of unused vaccines.

New Food and Drug Administration Commissioner Lester Crawford, says that previous shortages had highlighted the need for additional influenza vaccine manufacturers for the U.S. market.

Chiron announced this week that the FDA has issued a favorable report following a July inspection of its Liverpool plant.

According to the FDA Chiron has made "significant progress" on fixing its problems, but final approval would still need to be given before the vaccine could be sold.

Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, says that additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season.

Thomas Shrader, an analyst with Harris Nesbitt said the favorable inspection was not a surprise and he expects the FDA to approve Chiron's vaccine.

GlaxoSmithKline meanwhile, is planning to speed up production of its vaccine, which was cleared for use in adults age 18 and older.

CEO for the company, Jean-Pierre Garnier says they have worked quickly with government officials to make Fluarix available and increase supply at a critical time.

The British drug maker will join the only other drug maker cleared to sell the shots for the U.S. market, Sanofi-Aventis.

MedImmune Inc. also makes a nasal spray vaccine.