JULY 24, 2009
Swine Flu Prevention Takes on New Urgency
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Global health officials are scrambling to try to prevent the spread of the H1N1 swine flu virus, with U.S. officials moving Thursday with a recommendation that the Food and Drug Administration approve or license a vaccine.
In the U.S., a federal advisory panel said the FDA should move ahead to approve or license the new H1N1 vaccine without waiting to receive data from clinical trials to test its safety and efficacy. The government and vaccine makers plan to start human studies of the H1N1 vaccine in the U.S. in the coming weeks, but the first-look data from those studies won't be given to the FDA until September.
Each year the FDA approves seasonal vaccines based on strain changes without new human studies. The agency does test the vaccines for potency and also monitors vaccine safety on a continuous basis.
"I think this is an entirely appropriate way of proceeding and in the public health's best interest considering that schools will be opening in a month," said John Modlin, the panel chair and a professor of pediatrics at Dartmouth-Hitchcock Medical Center.
The new H1N1 shots would be for a vaccination campaign that potentially would be targeted first at school-age children, who along with young adults have been hit hard by the new flu strain. A Centers for Disease Control and Prevention vaccine advisory panel will meet next week to make recommendations about such a vaccination campaign.
Anthony Fiore, of the CDC's influenza division, said the agency is anticipating that two doses of an H1N1 vaccine would be needed. That limits the number of people at high risk for flu who would be able to get the shots in the early fall, although health officials are hoping that clinical study data will show that one dose is enough to protect some people. It will take until March to obtain enough doses for the entire U.S. population of just over 300 million people, officials predicted.
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