FDA Panel: Vaccine Protects Against a Cancer An FDA panel recommends the approval of a vaccine to prevent cervical cancer, the second-most deadly cancer for women. The new vaccine, made by Merck, could reduce the number of cervical cancer cases world wide by about two-thirds.
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FDA Panel: Vaccine Protects Against a Cancer

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FDA Panel: Vaccine Protects Against a Cancer

FDA Panel: Vaccine Protects Against a Cancer

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MICHELE NORRIS, host:

Today an FDA panel unanimously recommended the approval of a vaccine to prevent cervical cancer, the second most deadly cancer for women. This new vaccine, made by Merck, could reduce the number of cervical cancer cases worldwide by about two-thirds.

Joanne Silberner is on the phone with us now from the FDA hearing. Joanne how would this vaccine protect women against cancer?

JOANNE SILBERNER reporting:

Well, it all starts with a family of viruses called human papilloma viruses. Now some of these viruses, and it's a sexually transmitted virus, some of them can cause cervical cancer and genital warts. And what this vaccine contains is four of those parts of the virus family and by eliminating them you eliminate that cause of cancer.

NORRIS: And how effective is it?

SILBERNER: Very. At least against the four viruses that are included in the vaccine. But there are other less common members of that family that are not in the vaccine. So, that's why it's about roughly about 70 percent effective. In other words, it would reduce the number of cervical cancer cases in this country, which is about 10,000 a year, it could reduce that by 70 percent.

NORRIS: And would it also reduce the need for women to be routinely screened for cervical cancer with a pap test?

SILBERNER: No, actually. And this was talked about a lot at the meeting. A lot of people are concerned that if there's a vaccine people will feel protected and they won't get screened, but because it doesn't protect against all cervical cancers, that's one reason why the screen would have to be continued. Another is that no one knows how long this vaccine will last. It's that new.

I mean, they know it will last at least five years. But if it wears off after six or seven or ten years, you know, you don't want to wait until it happens before you realize that you should have continued to screen.

NORRIS: And who would get the vaccine and when?

SILBERNER: That's a great question. What the committee recommended is girls as young as nine, basically girls and women nine to twenty-six. The idea is you need to give it before people become sexually active. And there are vaccines that are given at that age in kids so why not just add that to that vaccine. It seems to be a safe vaccine, so there don't seem to be any troubles with that.

Another issue is boys. Should you give it to boys? There are some advantages because these viruses can also cause genital warts in boys. It can cause penile cancer, which is rare, but would be good to protect against. And as well as it could prevent men transmitting it to women, but there's not enough data yet. I think that's something that we might see a little further down the line.

NORRIS: Joanne, you said it seems to be safe. Are there any risks?

SILBERNER: Not really. And the side effect is really mainly a soreness at the site of the injection, which you see with a lot of vaccines. You know this was tested in about 26,000 girls and women. A couple of little things came up, but when you have a group that large those things were considered to be just part of the background.

The vaccine could wear off, that's a risk. There was some concern that by eliminating these four viruses you might make room for other viruses to grow. And that's not known yet and the FDA wants that followed.

NORRIS: And even with this unanimous approval any concern about giving it to young girls? You said girls as young as nine.

SILBERNER: Yeah. The risk there or the concern there has been, you know, if you tell a girl, gee, you're giving her this vaccine, it's going to protect against a sexually transmitted disease, is she going to think she's protected against all sexually transmitted diseases, which she would not be. But I think a lot of people who had that initial concern have backed off now because the idea of protecting against a cancer so effectively is a really winning one.

NORRIS: So, the panel approved this vaccine, does it mean it will be approved by the FDA and when will we know that?

SILBERNER: Well, the FDA doesn't have to go along with the committee, but in this case, and sometimes it doesn't, but in this case it was unanimous. So it's likely that they would. Their decision is due by June 8th. And after they make their decision whether to market it, Merck has said that it could have the vaccine available even by the end of June.

NORRIS: Thank you Joanne.

SILBERNER: Thank you.

NORRIS: NPR's Joanne Silberner.

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