The Times West Virginian

Headline News

September 16, 2009

New swine flu vaccine approved by FDA

(Continued)

WASHINGTON —

The vast majority of people who get swine flu “so far are not terribly ill,” Sebelius noted, saying most will recover fine at home with some rest and fluids. And they shouldn’t race to doctors’ offices seeking tests to find out what kind of flu they have — H1N1 or the regular strains that circulate every winter — because treatment is the same.

“The flu is the flu is the flu right now,” Sebelius said.

Nor should doctors hand out prescriptions for anti-flu medicines to be used to prevent flu, she added, because “it could make them sicker in the long run.”

The drugs Tamiflu and Relenza should be used for treatment only, she stressed.

Sebelius announced the FDA’s approval of vaccine made by four of the expected five manufacturers: CSL Ltd. of Australia, Switzerland’s Novartis Vaccines, Sanofi Pasteur of France — which produces flu shots at its Swiftwater, Pa., factory — and Maryland-based MedImmune LLC, which makes the only nasal-spray flu vaccine.

London-based GlaxoSmithKline also was expected to supply vaccine. Sebelius said only that a fifth manufacturer’s vaccine was expected to be approved soon, pending some final steps.

Getting licensing from the FDA means that the vaccine is made properly and meets specific manufacturing and quality standards.

What’s the right dose? Figuring that out is the job of the National Institutes of Health, which last week announced studies showing that one dose appears to protect adults — and that protection kicks in just eight to 10 days after the shot, faster than scientists had predicted.

Studies in children and pregnant women are continuing to settle on the right dose for those populations.

The H1N1 vaccine seems just as safe as the long-used regular flu vaccine, the FDA said, not a surprise as it’s made the same way. Side effects include soreness or redness at the injection site, and some fever.

The government will keep a sharp eye for any very rare side effects. The last mass vaccination against a different swine flu, in 1976, was marred by reports of the paralyzing Guillain-Barre syndrome; scientists never proved whether that link was real or coincidence.

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