A federal advisory committee Tuesday recommended approval of the first bird flu vaccine for humans, despite concerns about its safety and evidence that the shots won’t protect most people.
The panel said that while the vaccine had significant shortcomings, it was safe and effective for use during a pandemic or in high-risk situations, such as military deployment to regions facing an outbreak.
The vaccine, produced by the French drug company Sanofi Aventis, won’t be sold commercially. The government plans to buy and stockpile enough doses for 20 million people, including health care workers and emergency personnel.
Panel member Robert Webster, chairman of the department of virology and molecular biology at St. Jude Children’s Research Hospital in Memphis, Tenn., said the vaccine would be better than nothing.
“We need this prepandemic stockpile,” he said. “It worries me that if we don’t license this vaccine, what are the consequences?”
Norman Baylor, director of the FDA’s vaccine office, told the panel that the vaccine was a stopgap measure. “There are numerous vaccines under development that are potentially better than this one,” he said.
The Food and Drug Administration is not required to follow the advice of its outside experts but typically does.
The bird flu strain known as H5N1 originated in Asia. Although it rarely infects people, experts fear a mutation could make it easily transmissible, triggering a pandemic. From the start of 2003, 167 people, mostly in Asia, have died from the virus, according to the World Health Organization.