Swine Flu Vaccine Poses Challenges To FDA

As manufacturers start to roll out vaccines against the new H1N1 swine flu, the Food and Drug Administration will only have weeks to decide whether they're safe. It's a high-pressure situation, complicated by the memory of a flu-vaccine scare in 1976, and by a new ingredient that some manufacturers are experimenting with.

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There is another health care issue awaiting government action: the swine flu virus. As manufacturers begin to roll out vaccines against the new H1N1 swine flu virus, the Food and Drug Administration has to decide whether they're safe. Today, the agency will discuss what information it needs before giving the nod to a new vaccine. NPR's Joanne Silberner reports on the challenge facing the FDA.

JOANNE SILBERNER: New flu viruses show up every year, and the FDA routinely approves vaccines against them. The new H1N1 virus, though, is a little different. It showed up unexpectedly, late in the flu season. It's continued to circulate in the summer in places where kids gather, like summer camps. That will give it a jump start once school starts, which is why vaccine experts want to be ready early.

Dr. WILLIAM SCHAFFNER (Vanderbilt University): This is a little like the space program.

SILBERNER: That's William Schaffner of Vanderbilt University.

Dr. SCHAFFNER: There's something a little bit unknown and a little bit risky every time you shoot up a rocket and go to the moon, even though we have a vast amount of engineering information that's reassuring.

SILBERNER: Given that the future path of the new virus is uncertain, he says a small risk will be worth it. An Australian company has just begun testing its vaccine. Other manufacturers are geared up to go in the next couple of weeks. But it takes time for people in those trials to develop immunity and to measure that, says Jesse Goodman, the FDA's chief scientist.

Dr. JESSE GOODMAN (Chief Scientist, Food and Drug Administration): If all goes well, we expect to have substantive data within a couple of months of when the studies start. But, you know, there's a lot of uncertainties in conducting studies, getting the results.

SILBERNER: That's to be expected, says William Schaffner.

Dr. SCHAFFNER: The lights in the laboratories are on at night. People working day and night on this. Some of these things just take time. And remember, we don't want to cut a corner. We want to do it right so that when we deliver this vaccine to the American public, we can say it meets our standards.

SILBERNER: Part of the concern is something that happened back in 1976. Another swine flu hit a military base in New Jersey. The government launched a vaccination campaign. For reasons still not understood, several hundred people developed a serious neurological condition called Guillain-Barre Syndrome, or GBS. Still, says the FDA's Goodman, H1N1 viruses similar to the new one have been routine components of seasonal vaccines for decades.

Dr. GOODMAN: There has not been another year despite the use of hundreds and hundreds of millions of doses of these flu vaccines where there has been a significant increase in GBS.

SILBERNER: But he says the agency will be looking for that and other problems. Meanwhile, vaccine objectors are calling for the government to provide evidence that the vaccine is really needed.

At some point, though, you've got to go with what you've got, says Andrew Pavia of the University of Utah. The FDA is going to have to make a decision on licensing without all the information it might like to have.

Dr. ANDREW PAVIA (University of Utah): You can't study it in several million people in time to start using it where it will do some good. So you have to make your decisions based on preliminary studies.

SILBERNER: The FDA will eventually decide whether the vaccines can be marketed, but another group of government and university experts will recommend how the vaccine should be used. That group meets next week to decide who should get the vaccine first.

Joanne Silberner, NPR News.

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