Jun 8, 2006 6:16 pm US/Central
FDA Approves Cervical Cancer Vaccine
New Questions Raised As To Who Should Get Vaccine And When
by Mary Ann Childers
CHICAGO (CBS) ―
The Food and Drug Administration took a big step in the fight against cervical cancer on Thursday when it approved a new vaccine against the second leading cause of cancer deaths in American women.
CBS 2 Medical Editor Mary Ann Childers reports there are still big questions about who should get this vaccine and when.
Approximately 10,000 new cases of cervical cancer are diagnosed in the United States each year. Approximately 3,700 women die. That's why this new vaccine is being hailed as a potential lifesaver and the most important weapon against cervical cancer since the pap smear.
Manufacturer Merck & Co., Inc., says it's new vaccine, Gardasil, targets two types of Human Papaloma Virus, or HPV. HPV is a sexually transmitted virus believed to cause 70 percent of all cervical cancers.
"This vaccine was shown in clinical studies to be 100 percent effective in preventing the pre-cancerous lesions that are associated with cervical cancer," said Merck Vaccines president Margaret McGlynn.
The drugmaker believes Gardasil could cut cervical cancer deaths by two-thirds. The FDA has approved it for use in girls and women from 9 to 26 years old, but experts say it would be most effective if given before girls become sexually active.
"You really don't want to give say, your measles or mumps vaccine after you've been exposed," said Edwards Hospital pediatrician Ira Rubin.
Few argue with the vaccine's potential for preventing cancer, but some conservative family groups believe it should be voluntary and not required for school admission.
Others fear it could encourage sexual activity in young girls, but not Marie Mahoney, mother of 11-year-old Nora.
"I don't think this would change her attitude towards sex. If anything, it would make her be more aware of the consequences of becoming an adult woman," she said.
Maria says she'd get the vaccine for her daughter if her doctor recommended it.
"I think I would be more concerned about introducing to her the concept to her about cancer being a risk in her life, just because that would scare her more than anything else," Marie said.
Gardasil must be taken in three shots over six months. The Centers for Disease Control will ultimately decide what age to administer the vaccine. One thing everyone agrees on is that this vaccine will not replace the pap test.
"Yes, we need the appropriate behavior education in place, but we also need a cervical cancer vaccine, and we need to continue screening," Merck's McGlynn said.
Gardasil is not for people who already have HPV. But another vaccine for women 25 to 55 is also in development by Glaxo-Smith-Kline and is expected to come up for approval later this year. This second vaccine would be for woman who may already be exposed to HPV, and there are many. Fifty percent of sexually active adults are currently infected.
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