HPV vaccine nearing approval

FDA likely to OK immunizer that may eliminate most cases of cervical cancer


With conservative opposition softening, scientists say a vaccine that could eliminate most cases of cervical cancer appears headed toward government approval for girls as young as 9.

The Food and Drug Administration is expected to decide next month whether to grant a license to Merck & Co., which hopes to market the vaccine against the human papilloma virus (HPV). The sexually transmitted virus triggers both cervical cancer and genital warts.

If approved, it would become the first vaccine designed specifically to prevent a form of cancer. Because the virus spreads rapidly among teenagers once they become sexually active, proponents argue that the vaccine should be offered to preteen girls - and possibly boys.

FOR THE RECORD - An article yesterday about a vaccine for cervical cancer used a pre-merger name for GlaxoSmithKline, a pharmaceutical firm created by the merger of Glaxo Wellcome and SmithKline Beecham.
The Sun regrets the errors.

"I don't know how you argue against a vaccine that prevents cancer," Dr. David I. Bernstein, a pediatrician from the Cincinnati Children's Hospital Medical Center, said after addressing the National Foundation for Infectious Diseases in Baltimore on Tuesday.

The possibility of administering the vaccine to youths had raised concerns among social conservatives that it could send a message that teen sex is safe and acceptable. But many conservative groups, including some on the Christian right, say they support FDA approval as long as vaccination is not required for school admission - a decision typically left to states.

"We're health professionals," said Dr. Gene Rudd, a Tennessee obstetrician-gynecologist who is associate director of the Christian Medical and Dental Associations. "Where there are diseases out there, the only reasonable way you can protect individuals and society is to be immunized."

100% protection

After a two-year trial involving 12,000 sexually active women in 13 countries, Merck reported last year that the vaccine provided 100 percent protection against the two strains of the human papilloma virus responsible for 70 percent of all cervical cancers.

The vaccine is not likely to replace routine Pap smears because it doesn't fight all strains. Pap smears can detect precancerous cells that can be removed to prevent deadly tumors.

"This is a huge step," said Dr. Karen L. Kotloff, a professor of infectious disease at the University of Maryland's Center for Vaccine Development. "They tackled a virus that is known to be required to produce cervical cancer, and the data I've read suggests that it's one of the most effective vaccines available."

While Merck has applied for FDA approval, SmithKline Beecham is expected to ask permission later this year to market its own HPV vaccine. The Merck vaccine targets two strains responsible for cervical cancer and two that trigger genital warts, while SmithKline's targets the cancer strains only.

Although the FDA delighted conservatives when it refused to act on its own advisers' recommendation to make emergency contraception available without a prescription, most observers say the agency is likely to approve the HPV vaccine.

"It appears the FDA is doing the right thing, that they're looking at the science, and the science is good there," said Deborah Arrindell, vice president for health policy at the American Social Health Association. "The politics seem to have settled down for the moment."

Once the FDA rules on Merck's application, a group that advises the Centers for Disease Control and Prevention will make specific recommendations about whom should be vaccinated, including optimal age groups.

At a meeting in February, the Advisory Committee on Immunization Practices outlined the options. One was routine vaccinations for girls ages 11 and 12, while another was to include the vaccine in a "platform" of vaccinations that are typically given to youths of that age.

The committee's final recommendation could play a big role in whether government and private insurers agree to reimburse the cost of the vaccination. It could also influence whether low-income families can obtain free HPV vaccine through the federal Vaccines For Children program.

Dr. Gene Rudd of the Christian Medical and Dental Associations said in an interview that he would want his daughter and granddaughter vaccinated.

His group advocates abstinence before marriage and argues that promoting condom use among teenagers amounts to a tacit approval - if not an endorsement - of sexual activity. But like seat belts, he said, the vaccine isn't a license to engage in risky behavior but protects people against known dangers.

"Whether you're pro-condom or anti-condom, or pro-moral issues or anti-moral values, the issue is that the vaccine is not reasonably linked with any kind of risk-taking choices," Rudd said.

Parents' decision

Another Christian organization, Focus on the Family, says on its Web site that it supports "universal" availability of the HPV vaccine but believes that parents should decide whether to vaccinate a minor.

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