Health officials unsure about flu vaccine
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The flu vaccine supply for the upcoming 2005-2006 influenza season is still uncertain, with one maker racing to fix a closed factory and others trying to win new U.S. licenses, health officials said on Wednesday.
A U.S. Food and Drug Administration official said Chiron Corp. was still working on its facility in Liverpool, England, while GlaxoSmithKline was trying to get approval to supply the U.S. market for the first time.
Last October, Chiron’s license was suspended just at the start of flu season, with a loss of 48 million doses of vaccine - half the anticipated U.S. supply. The U.S. government scrambled to get together enough doses to cover those at risk of dying from influenza and ended up with 61 million.
Dr. Julie Gerberding, head of the U.S. Centers for Disease Control and Prevention, told a congressional hearing that 57 million flu vaccines were given in the 2004-2005 flu season - meaning 4 million doses were thrown out despite a panic that led to long lines for the shot.
Chiron had its license reinstated in March for manufacturing flu vaccine at the Liverpool plant but has not received the final go-ahead from regulators, including the FDA, to start making it.
“It is too early to predict the final outcome of Chiron’s remediation plan,” Dr. Jesse Goodman, head of the FDA’s center for biologics, told the hearing.
“I think things are moving in a positive direction but it is too soon to tell, so we do need to be prepared for a possible contingency,” Goodman told the hearing of the oversight subcommittee at the House of Representatives’ Committee on Energy and Commerce.
LIMITED MANUFACTURING
Regulators and Congress are concerned only two companies hold U.S. licenses for influenza shots - Chiron and Sanofi-Aventis unit Sanofi-Pasteur. MedImmune Inc. makes a nasal spray vaccine and plans to supply 3 million doses next year.
Goodman said GlaxoSmithKline was well along in the process of applying for an FDA license to supply 10 million doses for the U.S. market.
The officials said what was really needed was a modernized approach to making flu vaccine - in the best case, one that could be given once or twice in a lifetime and protect people against all strains of flu.
Current vaccines must be reformulated every year to match the quickly mutating viruses and are made using unwieldy technology and chicken eggs.
Gerberding said the CDC was preparing for the best and the worst next year.
“The worst-case scenario is we would have somewhere around 53 million doses,” Gerberding said. “The best case would be about 98 million doses.”
Either outcome would require careful public education to make sure the maximum number of doses got used by the people who need it most.
The CDC also has $30 million allocated to buy vaccine in bulk toward the middle or end of the season.
Gerberding said the agency was working to see if the market could be expanded to lure more manufacturers into making vaccine.
If studies show it will help protect the population, it might be possible to extend the recommended vaccination schedule to all school-age children, for example.
Influenza kills about 36,000 Americans and hospitalizes 200,000 each year.
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