FDA Meets On Swine Flu Vaccine The Food and Drug Administration is meeting Thursday to discuss a vaccine for the new H1N1 swine flu. Manufacturers are going to begin testing vaccines in people in early August, but it will be a couple of months before there's any meaningful data on the vaccine's safety and effectiveness.

FDA Meets On Swine Flu Vaccine

FDA Meets On Swine Flu Vaccine

  • Download
  • <iframe src="https://www.npr.org/player/embed/106939041/106940037" width="100%" height="290" frameborder="0" scrolling="no" title="NPR embedded audio player">
  • Transcript

The Food and Drug Administration is meeting Thursday to discuss a vaccine for the new H1N1 swine flu. Manufacturers are going to begin testing vaccines in people in early August, but it will be a couple of months before there's any meaningful data on the vaccine's safety and effectiveness.

ROBERT SIEGEL, host:

From NPR News, it's ALL THINGS CONSIDERED. I'm Robert Siegel.

MADELEINE BRAND, host:

And I'm Madeleine Brand.

Today, the Food and Drug Administration faced a question that we all may face in a few months: Is a vaccine against the new H1N1 swine flu a good idea? The agency sponsored a meeting to consider whether to license vaccines now being manufactured.

NPR's Joanne Silberner was at the meeting and she joins us now in studio.

And, Joanne, first of all, this virus, it was just identified in April. So is there going to be a vaccine available so soon in the fall?

JOANNE SILBERNER: Yeah, what happened was that the government and the World Health Organization, everybody was getting ready for the big avian flu that was going to come through and be really awful. It hasn't come through yet or at least not in a big way. But they had all these plans in place. They had - the manufacturers were alerted. There had been working groups working to get on how to expedite the process. The manufacturers already have seed stock, you know, basic virus for this current vaccine, and they've been working away at it.

BRAND: So I guess we all want to know the big question: Will this vaccine be safe?

SILBERNER: Well, that's the question of the hour. Now, there's every reason to believe that it's going to be safe because basically this is a seasonal flu that just has some weird attributes - it came a little bit late in the season, it's sticking around a long time. But other than that, as far as they can see, it's acting like a seasonal flu and every year we get new seasonal flu vaccines and they don't seem to be causing any problems.

The big thing that haunts everybody is what happened back in 1976, when as what looked to be a routine flu vaccine had some bad effects. Some people got a neurological condition called Guillain-Barre syndrome.

BRAND: Right. And that was when the government pushed a big vaccine effort back then in the '70s. Did anyone ever figure out what caused those problems?

SILBERNER: No, and everyone's dying to know. I think it's a thing that keeps vaccine planners up at night. They just don't know what happened. And was it a contaminant? Was it something about that virus? That was the virus that's somewhat similar to this virus. But we've had, you know, 30 years of virus - or 33 years of virus since then and - of vaccines, rather - since some of them are very similar and nothing's happened.

BRAND: So, Joanne, any reason, then, to think that this new flu is any different? And should it be treated any differently than from the regular flu?

SILBERNER: Well, so far, no, but they're watching carefully. They're alerting the neurologists who will notice if there's any Guillain-Barre syndrome coming up. They've got all sorts of plans so that if something happens, people will notice. But other than that, strange scheduling - coming in late in April, sticking around in the summer - other than that, this doesn't seem to be all that different.

BRAND: Children, though, seem to be especially vulnerable to this virus. And there was just a report today that four children infected with it had seizures. So is the vaccine going to be safe for them?

SILBERNER: Well, they aren't getting - they are getting infected more than older people. And that's probably because older people have been exposed to a similar virus and built up immunity. And kids haven't because that similar virus was years ago. They're getting it more. There are a couple of cases like that. But other than that, no, doesn't seem to be much special about kids. And they will be testing kids in this new series of tests when these new vaccines are tested. But they're so calm about this, actually, that it looks to me like the FDA is going to approve these vaccines just as a new seasonal flu.

BRAND: So, presumably, people will want this vaccine. Will there be enough?

SILBERNER: Possibly not right away. It depends. I mean, you have to say with this, if this all goes well, this vaccine - the virus is reproducing slowly, so it's making it a little bit difficult to make the vaccine. But they're making a lot of it. There may not be enough in September or even August when the kids come back to school and it starts spreading again. But by October, November, December, from the reports from the manufacturers today, it looks like there's going to be a lot of it around.

BRAND: NPR health correspondent Joanne Silberner. Thank you very much.

SILBERNER: Thank you.

Copyright © 2009 NPR. All rights reserved. Visit our website terms of use and permissions pages at www.npr.org for further information.

NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.