Safety of Swine Flu Vaccine to Face Tough Scrutiny

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 profile."

A more complete answer is that the public health system has come a long way since 1976 and should be able to head off or at least detect and interrupt such problems, experts said.

The situation today is already very different from that seen three decades ago. Take health officials' ability to monitor the spread of a disease and pick up on adverse events, for example.

"The Department of Health and Human Services has a number of things in place that will be used to catch early signals if there's any kind of issue and to monitor the safety of vaccinations as they're performed," said Dr. John Treanor, professor of medicine and of microbiology and immunology at the University of Rochester Medical Center, in New York.

Experts also pointed to more sophisticated detection, connectivity and surveillance systems worldwide that are able to monitor changes on an hourly basis.

That should mean that governments are better able now than in 1976 to quickly switch gears as new information emerges.

"The biggest policy error in 1976 was rolling everything up into a single go-no-go decision early in the year," Fineberg said. "That problem has already been averted. Decision-makers and policy-makers are taking it one step at a time, keeping everyone informed. They have avoided that error."

He added: "The second problem [in 1976] was more a strategy problem. They failed to ever think about times when they could reconsider. I think that is something the current crew has avoided by making clear that they are thinking about on-ramps and off-ramps and trying to identify exactly what would go into those decisions. That is an ongoing process."

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