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FRIDAY, Sept. 4 (HealthDay News) -- Despite persistent public concern that H1N1 vaccines being tested might have unforeseen side effects, experts reiterated Thursday that so far, at least, the shots seem safe.
"There have been no red flags at all," Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, told HealthDay.
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A trial designed to test the vaccine on healthy adults began on Aug. 7, while another trial involving children started Aug. 18.
"We wanted to wait about a week after the first trial to see if there were any glaring safety issues. There were not, so one-and-a-half weeks later, we started the trial in children," Fauci said.
And Fauci is optimistic that the vaccine will continue to be safe.
"It's unlikely there will be safety issues," he said. "We don't expect any because this vaccine is strikingly similar to the seasonal vaccine we give every year to millions and millions and millions of people."
Still, rare side effects will only come to light after millions of people have been vaccinated and after different population subgroups have been exposed to the vaccine.
"No clinical trial in the world is going to be large enough to be able to detect an event that occurs one in every 100,000 people," Fauci said. "The only way to pick that up is after the fact, when a lot of people get vaccinated and good surveillance picks it up."
Another expert agreed. "One of the challenges is that sometimes on the safety issue, only large-scale use will uncover rare events," said Dr. Melinda Moore, senior health researcher with the RAND Corporation in Arlington, Va., and a former epidemiologist with the U.S. Centers for Disease Control and Prevention. "That's not unique to this product. That's why there's so much after-market surveillance."
Such a surveillance system will be in place and operable when the first vaccinations start to roll out. Fauci anticipates that 45 million to 50 million doses will be available by Oct. 15.
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