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FDA issues guidelines to speed development of flu vaccines

Updated:
WASHINGTON (AP) _ Federal regulators published draft guidelines Thursday on ways to speed new flu vaccines to market for common winter influenza as well as an even deadlier strain of the virus.

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 by telephone.

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.

``As we build up our capacity to respond to seasonal influenza, it will put us in good stead,'' Fauci told a House subcommittee Thursday.

By next year's flu season, the United States should have the capacity to make 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 against the flu 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.

But 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.

Perhaps more importantly, the guidelines make clear that there are a variety of approaches to creating vaccines to fight the next pandemic.

The guidelines allow for emergency approval if a completely new super-strain of flu suddenly appears. Or, manufacturers could systematically create and stockpile a library of vaccines against brewing new strains.

They even allow for the possibility of one day vaccinating people against a potential future pandemic strain at the same time they get their regular winter flu shot.

``If that particular strain were to become the pandemic, at least we would not be naive to that strain. You could have that strategy,'' said Dr. Norman Baylor, head of FDA's vaccine office.

But rather than focus on any one strategy, the draft guidelines spell out different approaches to approval.

``What we really want to do is get manufacturers really ramped up, and bring on new manufacturers, so we can meet that target of making sure we have the capacity to make enough influenza vaccine ... for everyone who needs it,'' Baylor said.

In the case of a previously approved flu vaccine, manufacturers could tweak the vaccine for use against a new flu strain without having to seek a new license from the FDA, according to the draft documents.

Additionally, a manufacturer could receive ``accelerated approval'' for a new flu vaccine by performing studies showing that recipients experienced a surge in protective immune-system cells.

That kind of research can be done more rapidly than the traditional tracking of whether those recipients ever got the flu.

The FDA would, however, require follow-up studies on the new vaccines once they are in use, even in the midst of a pandemic, to be sure they work, according to the draft guidelines.

Health officials worry that bird flu, as it spreads well beyond Asia, could mutate into a strain that can be easily passed from human to human, sparking a pandemic. The World Health Organization has reported 174 human cases of bird flu, including 94 deaths.

The bird flu virus continues to evolve _ last year's strain looks different from this year's _ 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.
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