Cancer vaccine advances to FDA

Advisory panel recommends approval of shots for HPV, cause of cervical cancer

May 19, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- A vaccine for preventing most cases of cervical cancer moved closer to government approval yesterday, as an advisory panel recommended that federal drug regulators permit its use.

The unanimous endorsement makes it more likely that the Food and Drug Administration will allow sales of the vaccine, Gardasil, when the agency issues a final decision, expected early next month.

The FDA, which has been considering the vaccine on an expedited basis, usually follows the recommendations of its advisory committees, composed of scientists and representatives of consumers and industry.

"This is certainly a wonderful, good step," said advisory panel chairman Dr. Monica Farley, an infectious disease expert from Emory University's medical school.

Gardasil, made by Merck & Co., is the first vaccine designed to eliminate a form of cancer. It would immunize women against the sexually transmitted human papillomavirus, HPV, which causes cervical cancer.

Virtually all sexually active women acquire the virus, but it's usually harmless. The vaccine would stop those instances when the virus lingers and creates precursors to cancer.

The incidence of cervical cancer in the United States has dropped since the widespread use of Pap smears, but it is still expected to affect 9,710 women and cause 3,700 deaths this year. Worldwide, with screening not as common, the virus leads to 200,000 deaths annually.

Use of the vaccine is expected to drastically reduce the number of deaths.

Studies presented to the advisory panel showed the three-shot series was 100 percent effective in preventing the two main forms of the virus, which are responsible for 70 percent of cervical cancers. Studies indicated the vaccine is safe.

How long the vaccine will stay effective remains unclear. Studies found that it provided 90 percent protection against one strain of the virus after four years, according to Dr. Douglas Lowy and John Schiller, the two National Cancer Institute scientists whose research led to development of the vaccine.

Panelists and witnesses who testified during yesterday's daylong meeting stressed that screening should continue even after vaccinations commence, in part because the vaccine doesn't protect against all forms of the virus.

FDA approval had faced opposition from some social conservatives concerned that its introduction would signal an endorsement of sex, but those objections appear to have quieted given evidence of the considerable health benefits.

It might face more opposition after the FDA takes action, prompting a group that advises the Centers for Disease Control and Prevention to recommend who should be vaccinated and at what age.

The group could recommend vaccination of girls who are 11 and 12 years old. The vaccine is believed to work best if given before girls start having sex.

GlaxoSmithKline is developing another HPV vaccine, which it hasn't submitted for approval.

jonathan.rockoff@baltsun.com

The Associated Press contributed to this article.

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