FDA on Friday announced that it has extended approval for Merck's human papillomavirus (HPV) vaccine to adults ages 27 to 45. That vaccine, Gardasil 9, previously was approved only for people ages nine to 26.
A vaccine that can prevent cancer
HPV can lead to cervical, vulvar, vaginal, anal, penile, and throat cancers, as well as genital warts. According to the CDC, about 14 million people become newly infected with HPV each year, and about 33,700 adults are diagnosed with cancer caused by HPV, including 12,000 women with cervical cancer.
Gardasil 9 protects against protects against nine strains of the HPV virus, though it is not effective against strains individuals previously have been exposed to. According to experts, the vaccine is most effective when administered before people become sexually active. However, data also suggest it can benefit older individuals as well. While many adults have been exposed to some strains of HPV, few have been exposed to all of the nine types the vaccine covers.
How FDA decided to expand approval
FDA based the expanded approval on a study of an earlier version of Gardasil involving women ages 27 to 45. The study found the earlier version of the vaccine was very effective in preventing HPV infection, genital warts, and precancers related to the virus among women in that age group. FDA inferred the vaccine's effectiveness in men based on the study of women as well as from Gardasil's efficacy in younger men and evidence that it led to immunity in a study of men ages 27 to 45.
CDC's Advisory Committee on Immunization Practices is set to review the expanded age range of the vaccine at a meeting later this month and vote next year on whether to recommend use. If the panel recommends the vaccine, insurers are more likely cover it, according to the Washington Post's "To Your Health."
Adults 'want to feel protected'
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement said the approval "represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range."
Lois Ramondetta, a professor of gynecologic oncology at MD Anderson Cancer Center, called the expanded approval "great." She said, "There is a whole generation of people we were missing who didn't know about [the vaccine]. Doctors weren't good at talking about it."
William Schaffner, an infectious disease expert at Vanderbilt University, said many people over 26 had been asking their doctors about the HPV vaccine out of concern they might be exposed to the virus.
Separately, Ramondetta said, "They want to feel protected to some extent. Now they have that opportunity" (Grady/Hoffman, New York Times, 10/5; AP/Modern Healthcare, 10/7; McGinley, "To Your Health," Washington Post, 10/5; Ingram, MedPage Today, 10/7; FDA release, 10/8).
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