FDA gives Sanofi thumbs up for first bird flu vaccine
Food and Drug Administration (FDA) as a limited protection measure
in case of a pandemic.
The vaccine - the first of its kind to be approved for humans - could be used in the event the current H5N1 virus was to develop the capability to spread from human to human, the FDA said.
Avian influenza, or bird flu, does not normally infect humans, but there have been several examples in the last few years of transmission to people, leading to fears of a strain with the potential to lead to a pandemic.
Almost 300 people worldwide have been infected with the virus since 2003 and 172 of them have died, according to the World Health Organisation.
The vaccine, made by Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis, may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed, the FDA stated.
"The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and the world faces," said Andrew von Eschenbach, the FDA's commissioner.
"The approval of this vaccine is an important step forward in our protection against a pandemic."
The vaccine has been purchased by the US government as an emergency stockpile in case of an outbreak but will not be sold commercially.
The Department of Health and Human Services (HHS) said it had already bought 13m doses of the Sanofi vaccine, enough to immunise 6.5m people.
The US Strategic National Stockpile is maintained by the Centers for Disease Control and Prevention and contains large quantities of medicines to protect the public in case of emergency, which can be delivered to any state in the US within 12 hours.
The Sanofi vaccine was approved for people age 18 to 64, while clinical trials in other age groups are in progress.
The dosage is higher than the one used in seasonal flu vaccines, and two intramuscular injections must be given 28 days apart.
The vaccine will be manufactured at Sanofi Pasteur's Pensylvania facility.
"The licensure of the nation's first vaccine is a significant milestone in pandemic preparedness," said David Williams, president, chairman and CEO of Sanofi Pasteur, in a statement.
