US panel urges OK on bird flu vaccine
WASHINGTON -- It's better than nothing, federal health advisers said yesterday, in urging approval of the first bird flu vaccine as a stopgap against a potential pandemic until more effective vaccines can be developed.
The panel said in a 14-to-0 vote that the vaccine was effective, despite evidence that it wouldn't protect most people against the deadly H5N1 strain of bird flu. The panel then voted that it was safe.
"I hope we never have to use it," said panel member Dr. Melinda Wharton, deputy director of the national immunization program at the Centers for Disease Control and Prevention. "But this is the vaccine we have now."
The vote was taken after Food and Drug Administration officials said the Sanofi
The government plans to buy and stockpile enough bird flu vaccine for 20 million people, including emergency and healthcare workers. The Sanofi vaccine wouldn't be sold commercially.
Dr. Jack Stapleton of the University of Iowa Hospital Clinic called the vaccine "better than nothing." Fellow panelist Robert Webster of St. Jude Children's Research Hospital in Memphis likened the vaccine to a child's first step -- "very tentative and very necessary to do" -- before adding "there is a long way to go."
The recommendation now goes to the FDA, which isn't required to follow the advice of its advisory committees but usually does. The vaccine already is being stockpiled, even without FDA approval, for eventual interim use to protect emergency workers and first responders in a pandemic. It would be used until better vaccines could be developed.
Though not required for the limited usage planned, FDA approval of the vaccine would state the agency's opinion on its safety and effectiveness, said Dr. Jesse Goodman, FDA's chief of biologic products.
In a clinical trial, the two-shot series appears to provide protection to just 45 percent of adults who received the highest dose. An earlier analysis of the same study had suggested it prompted a protective immune response in 54 percent of patients, when measured 28 days after getting the second of two shots.
