FDA Panel OKs Bird Flu Vaccine Stockpiling
(WASHINGTON) -- A vaccine for the H5N1 avian flu, or bird flu, has been approved by a panel of experts to be stockpiled for emergency use in case of a pandemic.
A U.S. Food and Drug Administration advisory panel voted 14-0 in favor that the vaccine, manufactured by GlaxoSmithKline (GSK) in Quebec, was in compliance with licensing standards under accelerated approval regulations, reports MedPage Today.
H5N1 currently does not spread as easily among humans as it does among domestic foul, but flu experts have feared it could mutate and potentially lead to a pandemic. In infected humans, the virus is highly dangerous. The World Health Organization says since 2003, there have been 608 bird flu cases -- 359 of those cases resulted in death, according to MedPage.
Although the FDA isn't required to follow through with the advisory panel recommendations, it generally does, MedPage reports.
GSK, who has worked with the U.S. Department of Health and Human Services in developing the H5N1 vaccine, is hoping the agency will move forward on the panel's approval to stockpile the vaccine.
"We now look forward to a final decision by the FDA later this year and to also continuing our collaboration with the U.S. Government on public health issues," Glaxo VP of vaccine discovery and development, Bruce Innis said in a statement.
GSK says that in clinical trials, the most common side effects of the vaccine include pain at the injection site, swelling, muscle aches, headache, fatigue, joint pain, shivering and sweating.
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