FDA advisers OK Sanofi bird flu vaccine

Sanofi's experimental bird flu vaccine gets nod from FDA advisory panel for safety, effectiveness.

By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) -- A panel of FDA advisers voted to recommend approval of an experimental bird flu vaccine from the French drugmaker Sanofi-Aventis determining that it was safe and effective for the U.S. population, the company and the FDA said Tuesday.

If approved, Sanofi's (down $0.87 to $42.84, Charts) vaccine would be the first in the United States for the prevention of the bird flu, called H5N1. The Food and Drug Administration must still decide whether to OK the vaccine for use in the United States. The FDA usually follows the advice of its advisers.

"This is an important first step to preparing this nation for the pandemic," said Phil Hosbach, vice president of policy and government relations for Sanofi. "That means we have a chance at saving lives and halting the spread of the virus with this vaccine. The alternative is having nothing."

Some experts fear that the bird-flu virus will mutate into a strain that can be easily transmitted from human to human, sparking a mass pandemic.

This virus has posed the greatest threat to birds, infecting flocks in Asia and Europe, even spurring the government-mandated killing of millions of birds from poultry farms.

The fatal virus can spread to humans who are in close contact with infected birds. So far, 270 people in 10 countries have been infected and 164 of them have died, according to the FDA.

British drugmaker GlaxoSmithKline (down $1.21 to $55.70, Charts) is also developing a bird flu vaccine, which it submitted to European regulators on Jan. 29.

Swiss drug giant Roche produces the only FDA-approved treatment for bird flu: the anti-viral drug Tamiflu, which is not a vaccine. BioCryst (down $0.53 to $10.23, Charts) is developing an anti-viral, peramivir, that might someday compete with Tamiflu. Novartis (down $1.80 to $55.32, Charts), MedImmune (down $0.59 to $32.45, Charts) and Novavax (down $0.32 to $3.43, Charts) are also working on bird flu-related products.

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