Government Keeps Close Eye On Swine Flu Vaccine Public health officials are confident that the new H1N1 vaccine is safe. Still, as with any vaccine, they have systems in place to monitor vaccine recipients in order to spot any potential problems.
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Government Keeps Close Eye On Swine Flu Vaccine

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Government Keeps Close Eye On Swine Flu Vaccine

Government Keeps Close Eye On Swine Flu Vaccine

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From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.


And I'm Michele Norris.

The government is in the midst of a tough job. It's trying to get people vaccinated against swine flu and to reassure people that it's watching out for any potential problems with the vaccine.

As NPR's Joanne Silberner reports, the stakes are high.

JOANNE SILBERNER: This isn't the first time the government has backed a swine flu vaccine. David Sencer was head of the Centers for Disease Control and Prevention back in 1976 when swine flu hit an Army base. The government acted quickly. He remembers what happened.

Dr. DAVID SENCER (Former Director, Centers for Disease Control and Prevention): The first thing that we heard about was in about the third day of the program when three elderly people died in Pittsburgh. And immediately, that was tied to the vaccine.

SILBERNER: Each of the men had had heart disease.

Dr. SENCER: They were all in their 80s or early 90s, and people die at that age.

SILBERNER: Investigations clearly showed that the deaths had nothing to do with the vaccine. But today, the public is more aware of rare events. There's a 24/7 news cycle and the Web, ready and waiting to connect miscarriages, heart attacks and anything else to the vaccine. So, many government groups are monitoring the situation carefully. The military will be scanning and analyzing its data. The CDC's Dr. Beth Bell says her agency has many approaches to checking, one is with the Food and Drug Administration.

Dr. BETH BELL (Epidemiologist, Centers for Disease Control and Prevention): Doctors and patients can call or use a Web site to report any kind of adverse event that they think might have been associated with receiving this vaccine or, really, any vaccine.

SILBERNER: Unusual reports will trigger a deeper investigation, so will news stories, she says. Unlike 1976, researchers now have an enormous database of what is normal. A single report of an unusual heart attack isn't going to trigger anything. But a lot of heart attacks compared to the baseline will trigger analysis by the extra staff that have been added on for the new HIN1. The CDC and other government agencies are involved in another approach that wasn't available when swine flu was last in the news.

Dr. BELL: We have a longstanding project with a number of managed care organizations, which cover many millions of Americans, where we look every week.

SILBERNER: They're looking for things that have been associated with other vaccines, like neurological conditions, including seizures and Guillain-Barre syndrome. Guillain-Barre is a paralyzing condition that occurred in several hundred vaccine recipients back in 1976. Scientists are still arguing about the connection, but it did mark the beginning of an erosion of public trust in vaccines. Bell at the CDC says they're not expecting any problems with the new vaccine.

Dr. BELL: This vaccine is made in the same way that we make seasonal vaccine. And every year, we give seasonal vaccine to a hundred million people or more. And so, we know that the seasonal vaccines have an excellent safety record.

SILBERNER: Medical historian Howard Markel of the University of Michigan says even with scientists believing in the safety of the vaccine, surveillance is crucial. Attitudes have changed since the polio vaccine came out in the 1950s.

Dr. HOWARD MARKEL (Medical Historian, University of Michigan): It was an era where people really had a lot of trust in physicians and in scientists, and in the miracles of vaccines. And I think that's what's so different from today, is that there's a lot of distrust about vaccines.

SILBERNER: In fact, it's hard to find credible scientists who have problems with the way the government is handling this. Trust for America's Health, a watchdog group, says it's satisfied with the surveillance. But there's always that challenge when vaccination and a medical problem occur close together. It sure looks like the vaccine is at fault, says David Sencer, who was head of the CDC in 1976.

Dr. SENCER: It's very difficult to explain to the public that people die every day.

SILBERNER: So what the government has to do with its surveillance with each incident is figure out whether the incident is related to the vaccine. Failure to do that accurately could be very costly to public trust.

Joanne Silberner, NPR News.

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