TUESDAY, April 17 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first human vaccine to protect against the avian influenza virus, H5N1. In the case of a pandemic, the vaccine may provide "early limited protection" until a vaccine specific to the circulating strain is produced, according to the agency.
The vaccine, which will be manufactured by Sanofi Pasteur at the company's facility in Swiftwater, Pa., is to be delivered in two intramuscular injections about one month apart in patients aged 18 to 64 years.
In clinical trials, more than 400 adults were given the vaccine in 90 μg doses or lower and compared to 48 placebo-treated patients. About 45 percent of patients given two 90 μg doses developed protective antibodies. However, disease severity may be reduced in patients who do not achieve full immunity. The side effects included injection site pain, headache, feeling ill and muscle pain.
The vaccine will not be sold commercially but will be purchased by the U.S. government and included in the U.S. Strategic National Stockpile, which is maintained by the Centers for Disease Control and Prevention.
"The timing and severity of an influenza pandemic is uncertain, but the danger remains very real," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research, in a statement. "We are working closely with other government agencies, global partners and the vaccine industry to facilitate the development, licensure and availability of needed supplies of safe and effective vaccines to protect against the pandemic threat."
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