Adults up to age 45 can now be vaccinated against human papillomavirus (HPV), reducing their chances of getting cervical, oral and other cancers.
The Food and Drug Administration (FDA) announced Friday that Gardasil 9, a vaccine that works against nine different types of HPV, is now approved for both men and women between the ages of 27 and 45. Previously, it was approved only for those between the ages of nine and 26, and recommended for all children at age 11 or 12.
“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. ”The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90% of these cancers,” — including cervical, oral, penile and colorectal disease — “or 31,200 cases every year, from ever developing.”
The FDA opted to expand the age range after testing the first iteration of the HPV vaccine, which was approved in 2006, in more than 3,000 women between the ages of 27 and 45. Over an average of 3.5 years of follow-up, the vaccine proved to be 88% effective in preventing persistent HPV infection, as well as genital warts, precancerous legions and cervical cancers associated with the virus.
The FDA also did additional long-term follow-up with participants from that study, and conducted a smaller study in men ages 27 to 45. It also tested the safety of Gardasil 9 in about 13,000 men and women. Those results join a large body of evidence showing that the vaccine effectively prevents cancer and infections in people 26 and younger.
HPV, which is spread through sexual intercourse, is incredibly common in the U.S., affecting more than 40% of adults as of 2014. It causes the vast majority of cervical cancer cases in the U.S., killing an estimated 4,000 women each year, according to the CDC.
With HPV vaccination rates on the rise, CDC data shows that rates of cervical cancer dropped by around 1.6% each year between 1999 and 2015. But at the same time, rates of HPV-associated oral, anal and vulvar cancer have risen modestly in recent years, perhaps due to changing sexual practices in the U.S. and lax screening standards.
With expanded approvals for Gardasil 9, however, a whole new demographic can be vaccinated against these conditions.