Sunday, May 21, 2006
WASHINGTON — A vaccine with the potential to greatly reduce worldwide deaths from cervical cancer, the No. 2 cancer killer in women, should be approved for sales in the United States, a federal panel said yesterday.
A Food and Drug Administration advisory committee voted 13-0 to endorse Merck and Co.'s Gardasil as safe and effective. It blocks viruses that cause cervical cancer.
The company said the vaccine could cut worldwide deaths from the disease by two-thirds.
"This is certainly a wonderful, good step in addition to our screening processes" in helping eradicate cervical cancer, said Dr. Monica M. Farley of the Emory University School of Medicine, acting chairwoman of the advisory panel.
Tests in more than 17,000 girls and women have shown that the vaccine is nearly 100 percent effective in blocking cervical cancers caused by the sexually transmitted human papilloma virus. Two strains of the virus are thought to be responsible for 70 percent of the 15,000 cervical cancers diagnosed and the 3,500 deaths caused by it in the United States each year.
Worldwide, 400,000 women are diagnosed with cervical cancer each year and more than 200,000 die of it.
The virus, commonly called HPV, is the most common sexually transmitted disease in this country, with about 20 million people infected.
The FDA panel stressed that Gardasil does not eliminate the need for cervical-cancer screening, such as the Pap smear test, because the vaccine does not protect against all HPV strains.
The vaccine is most effective when given to girls before they become sexually active, which would require administration between the ages of 9 and 13.
The FDA is not required to follow the recommendations of its outside panels of experts, but usually does. The FDA is expected to decide by June 8.
Farley said Merck had submitted "very impressive data" to the panel about the vaccine's efficacy. [Impressively true or impressively fabricated?]
Public-health groups, nine of whom testified before the panel yesterday morning, were unanimous in recommending approval of the vaccine.
"It is common sense, good medicine and a groundbreaking step forward in the fight against cancer," said Cecile Richards, president of the Planned Parenthood Federation of America.
Making their case for approval, Merck officials suggested that Gardasil could be the biggest advance in preventing cervical cancer since the Pap test.
"Gardasil has the potential to meet an unmet medical need as the first vaccine to prevent cervical cancer," Merck's Dr. Patrick Brill-Edwards told the Vaccine and Related Biological Products advisory committee.
A vaccine utilization committee of the Centers for Disease Control and Prevention is scheduled to meet on June 29, at which time it could vote on whether to recommend universal use of Gardasil in females. A draft proposal recommends vaccinating all girls ages 11 and 12.
Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex.
Requirements for its use, however, can only be mandated by individual states.
Even if it should become a requirement, added Wendy Wright, president of Concerned Women of America, all states allow children to opt out of mandatory vaccinations for medical or other reasons.