Earlier in October, the news broke that the human papillomavirus (HPV) vaccine Gardasil 9 was approved by the Food and Drug Administration (FDA) to include women and men ages 27 to 45 years old. This is the latest evolution of the vaccine, which since 2014 has protected against nine types of HPV, compared with the four strains handled by its predecessor, Gardasil (approved in 2006).
The new age range caught some by surprise because up to that point the vaccine was largely advised for boys and girls younger than age 13 since the drug provides its best protection before sexual activity begins.(If the person was older than 13 but under 26, the FDA recommended they still get the HPV vaccine.) The Centers for Disease Control and Prevention (CDC) estimates that almost all people will have at least one form of HPV at one time or another, often without even realizing it. While many strains clear up and go away on their own, others can result in cervical cancer, genital warts and cancers of the anus, penis or back of the throat.
Currently, 80 million people in the U.S. alone are infected with some type of HPV, according to the CDC, with about 14 million new cases cropping up annually. Of those, nearly 34,000 cancer cases are diagnosed every year in the U.S. Worldwide, cervical cancer is the fifth leading cause of death for women, and the second most common form of cancer they experience.
So in a perfect world, it's best to knock the vaccine out before any sort of sexual activity begins. But what about young adults whose parents didn't let them get the vaccine as teens? Or adults reentering the dating scene after divorce or other long-term relationship? Sandy Pittman (real name withheld) fell into the latter category following her 2002 divorce at age 30, something her gynecologist took into consideration at her annual checkup in 2005.
"At the time, it was approved for use for those age 26 and under, but he felt that since I'd been married during that key 'dating and intimacy' timeframe the vaccine was targeting, that I would benefit as an 'older' dater," she recalls in an email interview.
Today, Gardasil 9 is largely covered by insurance (and is expected to be extended to the new age group thanks to the approval), but at the time Pittman received the vaccine she was left holding the burden of cost.
"I paid out of pocket for the series and knew that, at some point, people would see the value of such great advice and wisdom for those of us out there who weren't so experienced in the relationship/dating areas and had very limited sexual histories — I married the first man I had sex with," she says. "I'm glad to see the FDA has finally caught up with this. I know many doctors who have advocated for this for years, and I do think it's a life-saving vaccine for many."
Why the Age Change?
The seemingly sudden inclusion of the older age group is actually the result of years' worth of research and evaluation of the product's efficacy. "The vaccine was not originally approved for anyone who wanted it because there previously was not data to support the efficacy in the vaccine for patients over the age of 26," explains Dr. Kimberly Levinson, assistant professor of gynecologic oncology at Johns Hopkins Hospital via email. "The age extension is based on FDA review of a study that followed 3,200 women, showing that the vaccine was 88 percent effective at preventing HPV-related disease (specific to these nine HPV strains) in this age group."
Even men and women with prior sexual histories should consider getting the vaccine, according to Dr. Levinson. "Although most women in this age group have been exposed to HPV at some point previously, they may not have been exposed to all nine strains of HPV which are covered by the vaccine, and this will therefore continue to help prevent infection by these other strains of HPV," she says.
The FDA licensing is the first step toward out-and-out recommendation for the 27-to-45-ers. "CDC's Advisory Committee on Immunization (ACIP), which advises CDC on vaccine recommendations, has not voted to recommend the vaccine for older ages," explains CDC press officer Kristen Nordlund in an email, adding that the ACIP will discuss that at its October meeting.
Dr. Levinson is quick to stifle any criticism of Big Pharma's role in the expanded approval of Gardasil 9. "This is a vaccine that has been extensively researched, and has been shown to prevent pre-cancers and cancers due to HPV," she says. "The support for this vaccine is based on sound research that shows its efficacy."