The HPV Vaccine Is Now FDA-Approved for People Over 26: What You Need to Know
For years, health officials have urged people under the age of 26 to get the vaccine that protects against human papilloma virus (HPV). If you happened to miss that deadline or were older than 26 when the vaccine came out, it wasn’t recommended for you. But now, adults over 26 may want to consider getting it if they haven't already.
The Food and Drug Administration (FDA) recently approved expanding the use of one form of the HPV vaccine, Gardasil 9, to include people between the ages of 27 and 45. Gardasil 9 helps prevent certain cancers and diseases caused by the nine HPV types that are covered by the vaccine.
The approval “represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Peter Marks, M.D., Ph.D., 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 percent of these cancers, or 31,200 cases every year, from ever developing.”
Gardasil was originally approved in 2006 to prevent cancers and diseases associated with four strains of HPV.
Then, in 2014, Gardasil 9 was approved, covering an additional five strains. But both were only approved for use in people through age 26. And, according to the Centers for Disease Control and Prevention (CDC), kids should ideally get the vaccine when they're age 11 or 12. That's because the vaccine is most effective when you get it before you're exposed to HPV—the most common STI. So the goal is to get vaccinated before you become sexually active. But that doesn't mean that getting it later in your life is pointless.
The original 26-year-old cutoff was also partly due to the ages of participants included in studies used for the vaccine's approval. But new evidence suggests there may still be benefits to getting the vaccine at a later age. For instance, the FDA cites research (discussed in the prescribing information for Gardasil 9) in which about 3,253 women aged 27 through 45 were followed for an average of three and a half years and found that Gardasil was about 88 percent effective in preventing persistent HPV infection (which can lead to cancer), genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA says it approved the extended use of Gardasil 9 based on this data, combined with new long-term follow-up data from the study.
The FDA deemed Gardasil 9 safe for men in the same age group based on that data, as well as data from Gardasil used in younger men and data from a clinical trial of 150 men between the ages of 27 and 45 who received the HPV vaccine.
The new recommendation means that you can get vaccinated even if you've already been sexually active (and have already potentially been exposed to some strains of HPV). That's because "it is unlikely that they were exposed to all nine types of HPV that the vaccine protects against,” Susan Vadaparampil, Ph.D., M.P.H., vice chair of the Health Outcomes and Behavior Department at Moffitt Cancer Center, tells SELF. “Thus, there are continued opportunities for health benefit from receiving the vaccine after age 27.”
Almost everyone under age 46 who hasn't already gotten the vaccine is eligible for it, but some people may benefit more than others.
People ages 27 and older who haven't been vaccinated and are sexually active with any new partners may want to consider getting Gardasil 9, Vadaparampil says. That doesn’t mean you shouldn’t get it if you have had one long-term sexual partner, though. “It’s an important conversation to have with your doctor, who can help each person gauge the benefits for themselves,” she adds.
That said, doctors still don’t know when people are most likely to be exposed to the forms of HPV that cause cancer, Lois Ramondetta, M.D., a professor in the The University of Texas MD Anderson Cancer Center's department of gynecologic oncology and reproductive medicine, tells SELF. Meaning, you might have been exposed to a strain of HPV in the past that was relatively harmless for you, but you could still be exposed to a future strain that could lead to cancer. “Really, everybody under the age of 45 is eligible for this,” Dr. Ramondetta says.
However, if you got the “regular” Gardasil shot before Gardasil 9 became available in 2014, there’s no current recommendation to be vaccinated again, G. Thomas Ruiz, M.D., lead ob/gyn at MemorialCare Orange Coast Medical Center in Fountain Valley, Calif., tells SELF. He notes, “At this point, the original Gardasil still protects against most of the variants that cause cervical cancer." Dr. Ramondetta agrees: “The original Gardasil still protects against the forms of HPV that are considered the most dangerous,” she says—HPV 16 and 18. Still, there doesn't seem to be any harm in getting vaccinated again. "I know a lot of people who have done that," Dr. Ramondetta says.
People who are pregnant or allergic to any component of the vaccine (including yeast) should not get the vaccine.
If you haven't gotten the vaccine yet, talk to your doctor about your options and what you can expect.
Like all medications, there are some potential side effects of the HPV vaccine, including redness and/or pain and discomfort in the arm where you get the shot, dizziness, fainting, nausea, and headache, the CDC says. But the CDC also notes that the shot is “typically not associated with any serious side effects.”
“The HPV vaccine has been through the same rigorous process used for all vaccines to monitor safety on an ongoing basis,” Dr. Vadaparampil says. “Bottom line, the vaccine has been administered to millions worldwide and shown to be both safe and effective.” And not getting the vaccine makes it more likely that you'll develop complications related to HPV, possibly including cancer.
Plus, both Dr. Vadaparampil and Dr. Ramondetta anticipate the cost of the vaccine being covered by insurance for those through age 45, as it has often been in the past for those through age 26. Without insurance, the full series of three doses costs around $400, SELF reportedly previously.
Overall, doctors stress that it’s best to get the vaccine when you’re younger (if you can), but now anyone who missed out when they were younger still have the opportunity. “By using a prevention approach through vaccination while also remaining vigilant about screening, we have tremendous potential to eliminate cervical cancer in the U.S.,” Dr. Vadaparampil says.
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