t milestone in pandemic preparedness."
Sanofi manufactures the vaccine at a plant in Swiftwater, Pennsylvania.
Philip Hosbach, vice president for immunization policies and government affairs for Paris-based Sanofi, said the company was working to develop ways to make its vaccine more potent.
The U.S. Department of Health and Human Services said it had already purchased 13 million doses of the Sanofi vaccine, enough to inoculate 6.5 million people.
The vaccine was approved for people age 18 to 64. Studies in other age groups are ongoing. The most common side effects reported were pain at the injection site, headache, "general ill feeling" and muscle pain, the FDA said.
Clearance from the FDA will save doctors, hospitals and regulators hours, if not days, that would otherwise be needed to gain permission to use Sanofi's shot in a pandemic, said William Schaffner, a Vanderbilt University infectious disease specialist who advises the U.S. government on vaccines.
The vaccine would be given in two 90-microgram shots, about a month apart. Seasonal flu shots normally require about 15 micrograms of viral protein for each strain they protect against.
The U.S. has awarded contracts for a smaller number of shots to Novartis AG, based in Basel, Switzerland, and Glaxo SmithKline Plc of London.
Glaxo is developing an H5N1 vaccine using a booster, called an adjuvant, which makes its shot effective in two doses of 3.75 micrograms, almost 25 times smaller than Sanofi's.
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