HIV Digest	HIV Digest Archive

Merck & Co. has asked the Food and Drug Administration to review its application to market Gardasil, a human papillomavirus vaccine that could prevent 70 percent of HPV-related cervical cancer and 90 percent of genital warts. But the scientific community is not alone in weighing the use of the vaccine, which could be approved as soon as this year.

"The vaccine against human papillomavirus will markedly decrease the incidence of cervical cancer," said Dr. Juan C. Felix, chairperson of National Cervical Cancer Coalition's medical advisory board. Gardasil, he said, should be on the government's recommended list of vaccines because that would make poor, uninsured women eligible to receive it free. Cervical cancer kills mostly women who cannot afford screening, he added.

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But some conservative Christian groups worry that it could promote promiscuity, and they oppose making the vaccine mandatory. The Family Research Council director for life and women's issues, Pia de Soleni, hailed Gardasil as a "great advance" but added, "the issue for us is [parental] consent."

Asked if Merck is lobbying government officials to advise that pre-pubescent children receive Gardasil, Kelly Dougherty, a company spokesperson, replied: "It's not up to Merck to make that recommendation." However, Merck acknowledges it has discussed Gardasil with regulatory agencies, faith-based and women's groups.

If Gardasil becomes FDA-approved, the expert 15-member Advisory Committee on Immunizations Practices would then advise CDC whether it should be placed on a schedule of recommended vaccines. Ultimately, individual states would decide whether to make vaccination mandatory and to whom Gardasil should be administered. Vaccination would take three shots over six months.

GlaxoSmithKline is seeking European approval of its own HPV vaccine next year but would not say when it will apply for US approval.

Editor's Note: from New York Newsday