Like so many people, when the Gardasil vaccine was first introduced a few years ago to help prevent certain cancers caused by human papillomavirus, I was pretty excited. Then I read the guidelines and realized I was too old to get it. A cancer-preventing vaccine sounded too good to be true, and at the time, for a lot of us, it was. That’s why the Food & Drug Administration’s recent move to expand use of the vaccine for people ages 27 to 45 is such a big deal.
Let’s back up a second: Back in 2006, the FDA approved the first version of Gardasil, which was shown to prevent various cancers and diseases caused by four types of HPV. While that iteration is no longer distributed in the United States, in 2014, the FDA approved Gardasil 9, which not only covers the original four types of HPV but also an additional five strains and was approved for people ages 9 through 26.
The Centers for Disease Control reports that every year, around 14 million Americans become infected with HPV and about 79 million Americans total have HPV, so it’s incredibly common. What’s more is that each year, approximately 12,000 women are diagnosed with cervical cancer caused by HPV and more than 4,000 women will die from it — even with screening and treatment. In other words, the more people who can get the Gardasil vaccine, the more lives may be saved.
“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Dr. Peter Marks, 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.”
The FDA conducted a study (using the original 2006 formulation of Gardasil) involving approximately 3,200 women 27 through 45 years of age, tracking them for an average of three-and-a-half years, and found that the vaccine was 88 percent effective in the prevention of a combined end point of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions and cervical cancer related to HPV types covered by the vaccine.
Using these results, the FDA approved the newer formulation — Gardasil 9, which protects against five additional strains — for people ages 27 through 45. In the trial, participants reported the usual side effects associated with any vaccine: injection site pain, swelling, redness and headaches.
But what about the whole idea of giving the vaccine to young people before they become sexually active? It’s actually a little more nuanced than that. If a person has already been exposed to a certain strain of HPV, then the vaccine will not protect them against that strain. But it will work against any of the other strains — remember, there are a total of nine — included in the vaccine. So even if someone is sexually active and has been exposed to some of the strains of HPV, there is still a potential benefit to getting the vaccine.
Not only that, but some people don’t become sexually active until later in life, but because the FDA only approved the vaccine up until the age of 26, they weren’t able to get it without it being considered "off-label," which meant their insurance didn’t cover it. Now, most insurance companies should cover Gardasil for those in the approved age range.
Additionally, other people may have been in a long-term monogamous relationship with the same sexual partner for years — and had never been exposed to HPV — but now, later in life, are out of that relationship and becoming sexually active with new partners who might give them HPV. According to a report from the The New York Times, the FDA is currently looking into making a recommendation for the use of the vaccine in older people for scenarios like these.
The FDA hasn’t specified whether the vaccine regimen will look different for those older than 26. For now, if you’re between 27 and 45 and interested in getting the vaccine, talk to your doctor and check with your insurance provider to make sure it’s covered.
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