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Avian Flu : Preventing a Pandemic
posted by admin on 27/02/07

FDA Says Bird-Flu Vaccine Seems Safe; Efficacy Unclear

WASHINGTON -- The Food and Drug Administration said an H5N1 vaccine developed by a unit of Sanofi-Aventis appeared to be safe but it isn't clear how effective the vaccine would be at protecting people against avian influenza.

See complete coverage of efforts to contain avian flu, including an interactive graphic on the science of the virus and a look back at major flu epidemics.

The agency posted its views on the vaccine a day ahead of a panel meeting of outside medical experts. The panel is expected to weigh in on whether it believes the vaccine is safe and effective. The FDA would then take into consideration the panel's views when later deciding whether to approve the vaccine.

Currently, there are no vaccines approved for human use in the U.S. for an avian-influenza virus, such as H5N1.

Sanofi's vaccine is designed to protect humans against a particular H5N1 influenza strain that first started spreading among birds, and it isn't clear if the vaccine would offer protection in the event the virus mutates. The company is already producing the vaccine for placement in a U.S. government stockpile for use in the event of a flu pandemic.

Since 2003, the H5N1 strain has resulted in 167 deaths, mostly in Asia and Africa. Most of the human cases have been caused by direct contact with infected poultry, but health experts are concerned that, if the virus mutates, it might be able to spread easily among humans and spark the next pandemic.

FDA Says Bird-Flu Vaccine Seems Safe; Efficacy Unclear

The FDA said clinical studies of Sanofi's vaccine showed "no significant safety signals that would preclude administration of this vaccine to additional persons."

The FDA said the highest doses tested, two 90-microgram doses given one month apart, elicited a better immune response than lower doses that were tested. The study, which initially involved 452 people, showed that about 46% of people given the highest dose produced enough antibodies to suggest the vaccine would offer enough protection against avian flu.

However, the FDA said Sanofi's vaccine, if approved, could be used "in the interim" until other vaccines are developed.

Write to Jennifer Corbett Dooren at

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