FDA approves HPV Vaccine for adults over 26 and up to 45 in an effort to reduce HPV-caused cancers
The US Food and Drug Administration expanded its approval of the HPV vaccine to include women and men up to 45-year-old, in an effort to protect more people from several types of cancer -including cervical cancer- caused by the human papillomavirus.
The vaccine “Gardasil 9” prevents infection from the high-risk HPV types and until now it was approved for people ages 9 to 26.
The vaccine also protects against low-risk HPV types associated with most cases of genital warts.
The “approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
HPV infections are common, most sexually active women and men will become infected with HPV in their lifetimes. In most cases, the virus is cleared naturally by the body’s immune system. Sometimes that doesn’t occur and some people develop a lasting infection. Over the course of many years, the HPV infection transforms normal cells into precancerous lesions or cancer.
In the U.S. about 4,000 women die from cervical cancer each year and the burden is much higher globally. “High risk” HPV types also are associated with vulvar, vaginal, anal, penile, and many head and neck cancers.
Gardasil 9, which protects against nine HPV strains, is typically given in two doses, several months apart, to children 9 to 14, and in three doses for young people 15 to 26. For those older than 26, the recommended regimen will be three doses.
Experts say Gardasil 9 is most effective when administered before the initiation of sexual activity. However, data indicate that the vaccine can benefit the older people because even though many adults have been exposed to some types of HPV, most have not been exposed to all nine types covered by the vaccine.