U.S. clears new flu vaccine, progress made on another
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U.S. health officials approved a new flu vaccine on Wednesday in hopes of bolstering supplies after last season’s shortage, but said more work is needed before another supplier may be able to resume sales.
The new vaccine, made by GlaxoSmithKline Plc, aims to fill the void left after rival Chiron Corp. lost its license and could not deliver half the anticipated U.S. supply during the 2004-2005 flu season.
“Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health,” Health and Human Services Secretary Mike Leavitt said in a statement.
The approval comes just weeks before the start of the 2005-2006 U.S. flu season, which officials hope will not repeat last year’s scramble for the vaccine.
Last October, Emeryville, California-based Chiron’s manufacturing license for its Fluvirin vaccine was withdrawn because of contamination at its factory in Liverpool, England.
The loss of the expected supply led to early confusion and long lines. Officials searched for alternative supplies from around the world and imported 4 million doses from Glaxo.
While certain U.S. regions were temporarily left without vaccine, the season ended with a surplus of unused doses.
“Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market,” Food and Drug Administration Commissioner Lester Crawford said.
Chiron on Wednesday said the FDA issued a favorable report following a July inspection of its Liverpool plant, finding the company’s proposed corrections “generally acceptable.”
The FDA said Chiron had made “significant progress” in fixing its problems, but added the agency will still need to give final approval before the vaccine can be sold.
“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,” Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, said.
Harris Nesbitt analyst Thomas Shrader said the favorable inspection was not a surprise and that he expected the FDA to approve Chiron’s vaccine.
In the meantime, GlaxoSmithKline has said it plans to ramp up production of its vaccine, which was cleared for use in adults age 18 and older.
GlaxoSmithKline CEO Jean-Pierre Garnier said his company “worked quickly with government officials to make Fluarix available and increase supply at a critical time.”
The British drugmaker will join the only other drugmaker cleared to sell the shots for the U.S. market, Sanofi-Aventis. MedImmune Inc. also makes a nasal spray vaccine.
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