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Safety of Swine Flu Vaccine to Face Tough Scrutiny
Date:7/21/2009

Experts confident that U.S. won't repeat problems seen in 1976 episode

TUESDAY, July 21 (HealthDay News) -- A high-level U.S. government decision in 1976 to vaccinate 43 million people against swine flu backfired -- badly.

Not only did the dreaded outbreak never materialize (illness never spread beyond 240 soldiers stationed at Fort Dix, N.J.) but some 500 Americans who did get vaccinated came down with a rare neurodegenerative condition called Guillain-Barre syndrome, which many experts believe was linked to the shot. Twenty-five of those 500 people died.

Now U.S. health officials are considering a fall immunization campaign that could involve an unprecedented 600 million doses of vaccine for the currently circulating H1N1 swine flu vaccine.

How do health experts know 2009 won't be a repeat of the 1976 fiasco? Are there any guarantees the vaccine will be safe?

The short answers to those questions, according to the experts, are "we don't know" and "no."

"There will be no way to be certain until trials this summer," said Dr. Harvey Fineberg, president of the U.S. Institute of Medicine and author of The Epidemic That Never Was, a look back at the 1976 outbreak.

"And if we talk about relatively rare side effects on safety, by probability they will not show up until more people get the vaccine. This speaks to the need for continued surveillance. But, as far as efficacy and immediate reactions, we will have good information on that with the round of trials planned for this summer," he added.

Another expert agreed.

"We won't know that the vaccine is safe until it's given to large numbers of people," said Dr. Scott R. Lillibridge, a professor at the Texas A&M Health Science Center School of Rural Public Health in Houston and executive director of the National Center for Emergency Medical Preparedness and Response. "Every vaccine has a trade-off and a safety
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