FDA OKs 1st Bird Flu Vaccine
Vaccine Will Not Be Sold Commercially but Will Be in Government's Stockpile
April 17, 2007 -- The FDA today announced the first approval in the U.S. of a vaccine for humans against the H5N1 influenza virus, commonly called avian flu or bird flu.
The vaccine won't be for sale. Instead, the government has bought the vaccine for its strategic national stockpile.
The vaccine could be used in the event of an H5N1 bird flu pandemic. No such pandemic is under way, and no bird flu cases have been reported in humans in the U.S.
The vaccine is approved for use in adults aged 18-64 who are at increased risk of exposure to the bird flu virus that is covered by the vaccine.
First, patients would get a 90-microgram shot of the vaccine in their upper arm. They would get another 90-microgram dose of the vaccine in their upper arm 28 days later.
"The threat of an influenza pandemic is one of the most important public health issues our nation faces today," the FDA's Norman Baylor, PhD, said in a news conference.
Baylor directs the Office of Vaccines Research and Review at the FDA's Center for Biologics Evaluation and Research. He calls the vaccine's approval "an important step in enhancing our nation's readiness against a possible pandemic."
Bird Flu Vaccine
The FDA reviewed data from a clinical study in which 103 healthy adults received a 90-microgram dose of the vaccine followed by another 90-microgram dose 28 days later.
An additional 300 adults got lower doses of the vaccine, and 48 other adults got a sham injection (placebo).
The researchers checked the patients' immune system response to the vaccine. But they didn’t expose the patients to the H5N1 virus.
About 45% of those who got the two 90-microgram doses about a month apart had an immune system response that is expected to reduce the risk of getting influenza, according to the FDA.
The most common side effects seen in the study were pain at the injection site, headache, feeling generally ill, and muscle pain.
Other bird flu vaccines are in the works. Though a one-dose vaccine with greater effectiveness would be ideal, "this is where we are," Baylor says.
The vaccine is made by Sanofi Pasteur.