Bird Flu: Science and Policy

[DewDiligence]

FDA Finalizes Plan to Speed Flu-Vaccine Development

http://news.yahoo.com/s/nm/20070531/hl_nm/birdflu_fda_dc_1

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By Susan Heavey
Thu May 31, 5:29 PM ET

U.S. health regulators finalized guidelines on Thursday to speed development and production of vaccines against bird flu and seasonal strains of influenza.

The recommendations, proposed in March 2006, were designed to help manufacturers use newer technology that allows vaccines to be made faster once a strain of flu is identified, and to encourage more companies to get into the vaccine business.

"Having additional manufacturers of licensed influenza vaccines will enhance the capacity to produce more doses of seasonal influenza vaccines, as well as contribute to the nation's pandemic preparedness, one of our top priorities," said Jesse Goodman, director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research.

GlaxoSmithKline Plc, Sanofi-Aventis, Novartis AG, and MedImmune Inc. currently make seasonal flu vaccines for the United States.

Sanofi won U.S. approval in April for a vaccine against the H5N1 bird flu virus, which health authorities fear could mutate and spread from person to person causing a global pandemic. Glaxo and Novartis are also working on bird flu vaccines.

Vaccine makers say they rely on the government to recommend inoculation and to provide contracts to purchase and stockpile their products.

International health officials have said a global shortage of flu vaccine is expected to last for at least five years.

Under the final recommendations, the FDA outlined steps for companies seeking approval using newer manufacturing methods such as cell cultures or advanced genetic technology.

Companies using either method would have to provide data from clinical trials, the FDA said. But companies looking to use new technology could test vaccines against various predictors of how well a product works and conduct trials later to confirm results.

Drugmakers currently rely on chicken eggs that incubate the virus for months, which experts say is unreliable.

The guidelines are posted on the FDA's Web site at www.fda.gov/cber/gdlns/trifluvac.htm and www.fda.gov/cber/gdlns/panfluvac.htm .
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