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 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
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
The vaccine is made by Sanofi Pasteur.