FDA to Review Vaccine for Cancer-Causing Virus

The FDA is reviewing a novel new vaccine against human papilloma viruses, which cause cervical cancer. On Thursday, an expert panel will tell the FDA whether the new vaccine is ready to use.

Dr. Connie Trimble of Johns Hopkins School of Medicine is especially eager to see a vaccine approved. She works with women in the early and late stages of cervical cancer.

"It's amazing from a scientific standpoint that here's a cancer where we know the cause, we know how to screen for it, we know how to treat early-stage disease, and it's still the second-leading cancer killer of women worldwide," Trimble says.

Cervical cancer is not as widespread in the United States as it is in parts of the world with poor medical care, but it still hits 10,000 American women a year, and it kills about 3,700. That's why Trimble and other doctors are so interested in prevention, rather than catching the cancer in its early stage through a virus test or pap smear.

"If you have an abnormal pap smear, you have to see someone like me. People would rather go to the dentist," Trimble says. "You have to have a special exam, it's scary, it's uncomfortable, and you have to have a biopsy."

On Thursday, an advisory committee to the FDA will consider data from tests of an experimental vaccine made by Merck that targets four of the most carcinogenic forms of the human papilloma virus, or HPV. Tests of the vaccine showed that its highly effective, with few, if any, side effects. But the agency is asking the committee to consider whether knocking out four HPV viruses could leave room for others in the same family of viruses to grow.

The vaccine has a lot of support from people like Christopher Crum, a pathologist with Brigham and Women's Hospital. But he says it won't be the immediate end for pap smears and virus tests.

"We still need screening," Crum says. "Despite the fact that these vaccines are going to be effective, they're not going to completely eradicate the risk of cervical cancer."

About a dozen types of HPV are linked to cervical cancer. The four that are present in the vaccine are estimated to cause almost 70 percent of the cases.

It's not clear yet how long the vaccine will last. It has only been tested for five years. And there is still discussion about whether to vaccinate a group of people who don't get cervical cancer: men. HPV is a sexually transmitted disease, after all, and vaccinating men would likely protect their sexual partners.

There's a small advantage for men and boys: The vaccine protects against genital warts and rare cases of penile cancer.

If the FDA approves the vaccine, it's likely to decide not only who should get it, but at what age it should be taken. Trimble of Hopkins School of Medicine thinks children should receive the vaccine.

"It would have the most effect if we were able to vaccinate kids before they became sexually active," Trimble says.

There's no real opposition to this vaccine from groups that advocate abstinence until marriage. Dr. Gary Rose of the Medical Institute for Sexual Health, which advises conservative groups on medical issues, says most of those groups support it, and he recommends that the vaccine be given to the 9- to 12-year-old age group when they receive their other vaccines.

"We believe this is going to be very important in terms of prevention," Rose says. "The possibility of HPV infection remains from sexual assault, from date rape, and there's always the possibility that young people may marry someone who was previously exposed and is still carrying the virus."

The Family Research Council says the only thing they oppose is making the vaccine mandatory.

After it hears from the advisory committee Thursday, the FDA has until June 9 to decide whether to approve the vaccine. Manufacturer Merck isn't saying how much it would charge for the vaccine. Company observers predict it will be several hundred dollars for the three-shot series.

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