The first vaccine to prevent cervical cancer received Food and Drug Administration approval Thursday, a giant step in defeating a disease that kills as many as 290,000 women worldwide each year.
The Merck &Co. vaccine, Gardasil, prevents about 70 percent of cervical cancers by thwarting infection by two strains of the human papillomavirus, also known as HPV. HPV causes cervical cancer. Gardasil also prevents 90 percent of all genital warts.
The FDA approved Gardasil’s use in females ages 9 to 26. The list price for a three-shot regimen is $360.
Merck now has the only cervical cancer vaccine on the market and it could be on track for blockbuster status, some analysts say. Lehman Brothers analyst Tony Butler estimates Gardasil vaccinations of U.S. women alone could account for $1.3 billion in sales by 2008.
That would be welcome news for Merck, which has suffered a financial hit as a result of its Vioxx debacle.
While GlaxoSmithKline has a rival vaccine, Cervarix, the company has said it will not seek FDA approval until the end of this year.
Women should be vaccinated with Gardasil before ever having sexual intercourse. Women who have had sex might already be infected with HPV and if vaccinated, Gardasil might increase their risk of precancerous conditions.
“This vaccine is a significant advance in the protection of women’s health in that it strikes at infections that are the root cause of many cervical cancers,” FDA Acting Commissioner Andrew Eschenbach said.
And Merck chief executive Richard Clark said: “Bringing forward this lifesaving 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.”
On June 29, the national Advisory Committee on Immunization Practices will decide whether to recommend Gardasil’s use in female adolescents. But the individual states actually decide which vaccines to require.
Some conservative groups argue girls vaccinated with Gardasil might become promiscuous, knowing there’s a reduced risk of HPV infection. Some of those groups oppose mandatory Gardasil vaccinations.