Washington – Three jabs of a needle could give women an excellent shot at avoiding cervical cancer.
A new vaccine, approved Thursday by the Food and Drug Administration, is the first to protect against the No. 2 cancer killer in women.
The three-shot, $360 series should be available by the end of the month.
Its manufacturer, Merck & Co. Inc., eventually hopes to win worldwide approval to sell the vaccine, called Gardasil. The company says Gardasil could cut by two-thirds the 240,000 cervical-cancer deaths estimated to occur around the world each year.
“FDA approval of the HPV vaccine, the first vaccine targeted specifically to preventing cancer, is one of the most important advances in women’s health in recent years,” said Dr. Carolyn Runowicz, president of the American Cancer Society.
The FDA licensed Gardasil for use in girls and women ages 9 to 26. The vaccine works best when given to girls before they begin having sex and become infected by human papillomavirus, or HPV.
The vaccine works by preventing infection by four of the dozens of strains of HPV.
The virus is the most prevalent sexually transmitted disease. It’s so common that by age 50, 80 percent of women have been infected.
Gardasil protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases.
Early vaccination is key: Gardasil does not protect those already infected.
In women not previously infected, clinical trials showed Gardasil prevented 100 percent of cervical cancer related to the two HPV strains, Merck said. It also prevented 99 percent of the cases of genital warts caused by the two other strains.
“Fortunately, we can now include the worst types of HPV and most cervical cancer in the list of diseases that no one need suffer or die from ever again,” said Alex Azar, deputy health and human services secretary.
The vaccine comes with an apparent bonus: Research presented earlier this month suggests Gardasil also protects against vaginal and vulvar cancers linked to the four types of HPV.
The FDA said that Gardasil appeared very safe but that it can’t vouch for how long its effect may last. Merck plans to study its long-term effectiveness. It continues to study whether it can be given to males.
Merck intends to market Gardasil as a cancer vaccine rather than an STD vaccine.
Conservative opposition to making Gardasil vaccination a prerequisite for school attendance could limit its widespread use, as may its cost. Merck plans to provide it for free to the poor and uninsured.
The national Advisory Committee on Immunization Practices will decide June 29 whether to endorse vaccination with Gardasil. That endorsement is critical if the vaccine is to become routine.
Sen. Frank Lautenberg, D-N.J., urged the panel to put “science and women’s health ahead of ideological opposition” in considering a recommendation.
It then will be up to individual states to decide whether to add the vaccine to the list of others required before students may attend public schools.
Conservative groups such as Focus on the Family support availability of the vaccine but oppose making it mandatory, saying the decision to vaccinate should be up to a child’s parents or guardians. The group promotes abstinence as the best way to prevent infection by HPV and other STDs.
The vaccine does not eliminate the need for the regular Pap tests that can detect precancerous lesions and early cancer.
