Merck Cervical Cancer Vaccine Approved
Biotechnology
Merck Cervical Cancer Vaccine Approved
Matthew Herper, 06.08.06, 5:15 PM ET
The first vaccine against the virus that causes cervical cancer has been cleared by the U.S. Food and Drug Administration.
The vaccine, Gardasil, is the most promising product brought to market by drugmaker Merck (nyse: MRK - news - people ) in years. It could help the embattled firm get past the gloom brought on by thousands of lawsuits related to its withdrawn painkiller Vioxx. Cervical cancer kills 3,700 women in the U.S. each year.
"Merck is proud to be the leader in cervical cancer vaccine research and development," says Merck Chief Executive Richard T. Clark. "Bringing forward this life-saving scientific advance is yet another testament to Merck's long-standing mission to research and develop novel vaccines and medicines that can greatly improve public health."
But Gardasil's approval also draws Merck into a new controversy. The vaccine works by preventing a sexually transmitted disease--the human papillomavirus, or HPV--that infects some 20 million Americans and is the main cause of cervical cancer. Some groups, including Focus on the Family, have opposed making the vaccine mandatory for children entering public school because vaccination could discourage sexual abstinence.
Merck is already making the case that vaccinations should begin early. It says one in four people between the ages of 15 and 24 are infected with HPV, and that 80% of mothers say that they would vaccinate their daughters, given the chance. The company has begun running television advertisements to educate the public about the existence of the virus.
Gardasil, which will cost $360 per patient to administer, will face another hurdle on June 28 and 29, when a panel will consider exactly what kinds of vaccinations the Centers for Disease Control should recommend.
Right now, the vaccine is cleared for use only for women and girls between the ages of 9 and 26. But the argument has been made that vaccinations should start even earlier to be sure to prevent infection. Researchers have also argued that it might make sense to vaccinate boys as well, because the vaccine also prevents genital warts, and because men pass the HPV virus to women.
Some experts are also concerned about how to get the expensive vaccine to the developing world, where HPV is an even greater scourge. Worldwide, cervical cancer is the second-most-common cancer in women and kills 233,000 annually. The international health group Program for Appropriate Technology in Health, funded by Microsoft (nasdaq: MSFT - news - people ) founder Bill Gates, recently launched a five-year drive to get cervical cancer vaccines to poor countries.
GlaxoSmithKline (nyse: GSK - news - people ) is developing its own cervical cancer vaccine, Cervarix, which some studies show may be even better than Gardasil at teaching the immune system to fight off the virus. Most analysts expect Merck to keep a substantial market share lead. Biotech MedImmune (nasdaq: MEDI - news - people ) will get a royalty from the sale of both vaccines.
Here's a link to Merck's approval news.
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