May 18, 2006 — -- A Food and Drug Administration panel voted 13-0 today to endorse a promising new vaccine that could stop viruses that cause nearly 70 percent of all cervical cancers and genital warts, but the potential distribution of the vaccine is causing political and cultural controversy.
Merck & Co. is seeking approval for its Gardasal vaccine against four types of human papilloma virus. Doctors are calling the vaccine a monumental advance.
"We stand at a historic moment of wiping out a disease with a vaccine," said Dr. Carolyn Runowicz, president of the American Cancer Society. "We have to go for it."
The science behind the vaccine appears solid. Studies submitted by Merck found the vaccine can be 100 percent effective and discovered no problems with safety.
"I'm really encouraged that the scientific evidence is so overwhelming about what good this could do for women is being taken seriously at the FDA," said Sen. Hillary Clinton, D-N.Y.
But beyond the medicine, there are questions about who should get the vaccine and when.
Merck says the vaccine can work on girls as young as 9 years old, and some supporters say the vaccine should be part of a list of shots pre-teen girls are required to have.
But conservative family groups say parents should have a choice.
"This is a disease that's sexually transmitted," said Linda Klepacki, spokeswoman for Focus on the Family. "Because of that, this is a very personal subject and we feel parents should make that decision for their children."
Other opponents go further. Hal Wallace, head of the Physicians Consortium, says the vaccine would send kids a message that, "you just take this shot and you can be as sexually promiscuous as you want."
Last year, a Centers for Disease Control and Prevention study found 11 percent of physicians worried that the vaccine might encourage more risky sexual behavior, but advocates of the vaccine say that's an unfounded fear.
"Data has shown if you give kids a helmet it doesn't make them fall off [their bike] and it doesn't make them drive crazy," Runowicz said.
The full FDA will review the recommendations from today's hearing and could approve the vaccine in early June. Merck says it could have the vaccine in doctors' offices within a month after approvals.