FDA Reassures Doctors Skeptical Of H1N1 Vaccine
It's difficult to find doctors who don't believe in the new H1N1 swine flu vaccine, but there are a few. Some of those doubting doctors are concerned about all vaccinations, or are not convinced that the H1N1 vaccine has been vetted enough, despite the government's intensive monitoring program.
The federal government is trying to win over doctors reluctant to endorse the new H1N1 swine flu vaccine. Earlier this month, Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration, issued her first "Dear Doctor" letter, encouraging physicians to educate themselves about the safety and effectiveness of the vaccine. A meeting at the FDA Wednesday will review the government's monitoring efforts. The vaccine is safe and has not been connected to any unusual events, according to the Centers for Disease Control and Prevention.
"The benefits of preventing serious consequences from infection with the 2009 H1N1 influenza virus far outweigh the risks associated with vaccination," she wrote.
"We really want people to understand that vaccination is the best way to prevent and control H1N1 infection," Hamburg told NPR. Polls show people weight their doctor's opinion the heaviest when seeking help with medical decisions.
Major medical organizations have endorsed the vaccine, including the American Medical Association, the American Academy of Family Physicians, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.
But there are some physicians who are hold-outs. Some of them are opposed to any vaccine, believing that if people focus on keeping up their immunity, they won't get sick. Others, like Dr. Laurence Murphy of Burke, Va., are concerned that the vaccine hasn't been tested enough.
"They were so aggressive in pushing it without mentioning the fact that they didn't have time to do the thorough efficacy studies on it," Burke says. "Two to three months from now we'll know."
Hamburg says the vaccine was tested the same way the seasonal vaccine is tested. "There's been a lot of confusion about this vaccine," she says. "We want to make sure everybody understands that it's just a variation on the seasonal flu vaccine."
As with the seasonal flu vaccine, the FDA certified that manufacturers are using the same production methods and equipment, and that the manufacturers check each lot for purity. The H1N1 vaccine went through more initial testing than seasonal flu vaccines — it was tested in several thousand people, which is generally not done with the conventional seasonal flu vaccine.
But doctors such as Laurence Murphy are concerned about rare side effects — the one-in-a-million kinds — that don't appear until a vaccine has been tested on hundreds of thousands of people.
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