In a major advance for women’s health, a Food and Drug Administration advisory panel recommended Thursday that the agency approve a new vaccine against a sexually transmitted virus that causes cervical cancer.
The unanimous recommendation inspired cheers from the medical community, which said the vaccine could help save the lives of tens of thousands of women worldwide.
“This gives us the tools to begin to wipe out cervical cancer not only in the U.S. but across the globe,” said Dr. Yvonne Collins, assistant professor of gynecologic oncology at the University of Illinois at Chicago.
The FDA usually follows the recommendations of its advisory panels. It is expected to approve the vaccine in early June.
Despite earlier concerns about the vaccine’s potential impact on young people’s sexual behavior, conservatives applauded the development. “It’s a huge medical breakthrough,” said Linda Klepacki, an analyst who covers sexual health for Focus on the Family.
For the cancer community, “this is a watershed event … that we hope will help usher in a new era of cancer prevention,” said Carolyn Runowicz, president of the American Cancer Society. Gardasil, made by Merck & Co., is the first vaccine specifically designed to prevent cancer, she said.
The vaccine targets four strains of the human papilloma virus, the most common type of sexually transmitted infection. Two of the strains are responsible for 70 percent of cervical cancer cases in the U.S. and across the world.
“Imagine being able to eliminate more than two-thirds of the cases of this cancer. What could be more exciting,” said Dr. Bobbie Gostout, a gynecologic oncologist at the Mayo Clinic.
The vaccine is 100 percent effective against these two strains of HPV in young women 16 to 26 years old, Merck’s research demonstrated. It also can help prevent genital warts, also caused by HPV.
Nearly 10,000 women are newly diagnosed with cervical cancer each year in the U.S.; 3,700 succumb annually to the disease. Worldwide, yearly deaths total about 240,000, according to the World Health Organization.
Merck is prepared to make Gardasil available “within weeks” after the FDA issues a final decision on the vaccine, said Dr. Rick Haupt, executive director of medical affairs for the drug company. “We’re thrilled,” he said.
A full inoculation involves three injections over six months and is expected to cost $300 to $500.
If Gardasil is approved, the Centers for Disease Control’s Advisory Committee on Immunization Practices will come up with a plan for distributing the vaccine in late June. The CDC is responsible for issuing guidelines for vaccinations.
Merck is recommending that girls as young as 9 and women up to age 26 receive the vaccine. Preteens are a primary target because “the vaccine has its biggest impact prior to sexual exposure” that can lead to an HPV infection, Haupt said.
“The reality is, some young women are infected with HPV, with or without their knowledge, at an early age, and if you’re going to inoculate them before infection you have to start young,” said Dr. Julian Schink, chief of gynecologic oncology at Northwestern University’s Feinberg School of Medicine.
Initially, conservative groups seemed alarmed that Gardasil might encourage promiscuity. “Our concern has been that this vaccine not be presented as a shot that makes it safer to have sex,” said Peter Sprigg, vice president for policy at the Family Research Council.
But after extensive discussions with Merck officials, the council became convinced this wouldn’t happen. Instead, “this could be used as an opportunity to talk to young people about their sexual health and how to manage risks, and that could be quite positive,” Sprigg said.
Meanwhile, Merck is studying whether boys and older women should get the vaccine, but those results aren’t available yet.
It makes sense to vaccinate boys because they can transmit HPV and contract anal or penile cancer from infections, said Collins of UIC. If Gardasil proves effective at curbing the virus and reducing cancer risk in boys, “I’ll vaccinate my 4-year-old when he comes of age,” she said.
The question of what older women should do is more complicated. Most women who are sexually active probably have been exposed to HPV and many have developed some form of immunity to the virus, experts said. That could alter their response to the vaccine, some experts suggest.
“A lot will depend on a woman’s sexual history. We’ll have to counsel her that the vaccine may not be as effective if she already harbors the virus,” said Dr. Diane Yamada, section chief for gynecologic oncology at the University of Chicago Hospitals.
Documents prepared by the FDA suggest some women with persistent HPV infections could be at higher risk of cervical cancer after taking the vaccine. Merck officials respond that this finding came from a limited analysis and was not supported by a more extensive review.
“There is no evidence of risk for women who have already been infected,” Haupt said.
“There’s benefit to getting this vaccine, even if you’re sexually active and even without knowing if you have HPV.”
Haupt doesn’t expect women to be tested routinely for HPV before being inoculated, in part because commercial tests can’t pinpoint which HPV strain a woman has.
Most HPV infections clear up on their own; those that linger are most likely to develop into cancer.
Pap smears will remain a critical tool in the battle against cervical cancer, because 30 percent of these cancers won’t be prevented by Gardasil. That’s because the vaccine singles out only four of more than 30 sexually transmitted strains of HPV. “Adult women will want to continue getting these tests, which remain an extraordinarily valuable way to detect this disease early on,” said Schink of Northwestern.
GlaxoSmithKline, another drug company, expects to apply for U.S. approval of a second HPV vaccine, Cervarix, by the end of this year.
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Facts on cervical cancer, vaccine
– Almost 10,000 women in the U.S. will find out they have cervical cancer this year. Some 3,700 women will die of the disease.
– Worldwide, about 240,000 women die of cervical cancer annually.
– Gardasil is a new vaccine designed to prevent cervical cancer by targeting four strains of the human papilloma virus, a sexually transmitted infection.
– Merck & Co. wants doctors to give the vaccine to females 9 to 26 years old. Its research shows Gardasil is safe and effective in this group.
– Merck is studying whether the vaccine is effective for boys and older women.
Sources: FDA documents, Merck & Co.
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jegraham@tribune.com
