FDA panel endorses cervical cancer vaccine
A vaccine that blocks viruses that cause most cervical cancer is safe and effective and should be approved, a federal panel recommended yesterday. The maker of the drug said the vaccine could slash global deaths from the No. 2 cancer in women by more than two thirds.
A Food and Drug Administration advisory committee voted 13 to 0 five separate times to endorse Merck & Co.'s Gardasil. The anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500—a possible impediment to widespread vaccination campaigns.
The drug protects against the two types of human papillomavirus (HPV) believed responsible for about 70 percent of cervical cancer cases. The vaccine also protects against two other virus types that cause 90 percent of genital wart cases. All four virus types are sexually transmitted.
The FDA is not required to follow the recommendations of its outside panels of experts but usually does. An agency decision is expected by June 8.
HPV is the most common sexually transmitted disease. It affects more than 50 percent of sexually active adults. The cervical cancer that it can cause annually kills about 290,000 women worldwide, including 3,500 women in the United States, where regular Pap smears often detect precancerous lesions and early cancer.
"This is certainly a wonderful, good step in addition to our screening processes" in helping eradicate cervical cancer, said Monica Farley, who heads the advisory panel. She is a bacterial infectious disease expert at the Emory University School of Medicine.
Making their case for approval, Merck officials suggested that development could make Gardasil 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 Patrick Brill-Edwards told the vaccine and related biological products advisory committee.
Several speakers said the vaccine should not replace screening. Merck said the drug is not intended to do that.
"We would like to see the FDA mandate some sort of labeling or other mechanism to communicate to healthcare providers and patients the continued need for regular cervical screening," said Amy Allina, program director of the National Women's Health Network.
Merck said the vaccine could be used in females ages 9 to 26 but would work best when given to girls before they begin having sex.
A government-established vaccine group is recommending giving the vaccine to girls 11 and 12. A 15-member committee of experts who advise the government will consider recommendations for females 13 to 26.
Early opposition to Gardasil was based on concerns it could encourage sexual activity in the young. But that largely faded away because of the vaccine's potential for reducing cancer.
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