FDA creates rules to speed development of flu vaccines

WASHINGTON — Federal regulators published draft guidelines yesterday on ways to speed new flu vaccines to market for common winter influenza as well as an even deadlier strain of the virus, such as bird flu that has health officials worldwide worried about a pandemic. The guidelines, prepared by the Food and Drug Administration, spell out data the agency is requiring of manufacturers to demonstrate that new flu vaccines are safe and effective. The public has 90 days to comment before they are finalized. Eventually, the guidelines could knock one to two years off the time it takes to develop and license a new flu vaccine, Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, told reporters in a conference call. Boosting the capacity to produce vaccines against the seasonal flu, which kills 36,000 Americans a year, should put the U.S. in a better position to respond to a potential global outbreak of pandemic flu, which could kill millions, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. By next year’s flu season, manufacturers should be able to provide the United States with between 100 million and 120 million doses of flu vaccine. The Centers for Disease Control and Prevention, however, estimate 185 million Americans should be vaccinated each year. The FDA hopes the guidelines will increase the robustness of the vaccine industry. Many of those guidelines reiterate FDA policies already in use, such as when the agency quickly approved last year’s new flu shot Fluarix, made by a subsidiary of GlaxoSmithKline. Others suggest that the FDA is thinking critically about how to oversee more novel approaches to flu-vaccine development currently being researched — such as nasal-spray vaccines containing live, but weakened, strains of bird flu. Health officials worry that bird flu could mutate into a strain that can be easily passed from human to human. The World Health Organization has reported 174 human cases of bird flu, including 94 deaths. The bird flu virus continues to evolve as it spreads, CDC Director Dr. Julie Gerberding told members of Congress. "We need to expect a bird arriving with this pathogen in the United States," Gerberding said. "Spource":[ http://www.columbusdispatch.com/health/health.php?story=dispatch/2006/03/03/20060303-A9-00.html].

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