FDA expands age range for HPV vaccine
For years, Dr. Zane Saul had heard tales of people who wanted to protect themselves from a sexually transmitted disease that’s been linked to several deadly cancers — but were told it was too late.
Gardasil and its successor, Gardasil 9, were vaccines approved to prevent most types of the STD human papillomavirus, commonly called HPV.
The vaccines were only approved for use in those aged 9 to 26, which means insurance wouldn’t cover the shots for people outside that age range, said Saul, chief of infectious disease at Bridgeport Hospital.
“We had patients in their late 20s and early 30s coming in, wanting to play catch-up, but they couldn’t get a payment source,” for the vaccine, he said.
Soon, though, such patients may be able to get the vaccine.
On Oct. 5, the Food and Drug Administration announced
it was expanding the approved use of the vaccine to include those aged 27 to 45. The vaccine helps prevent certain cancers and disease caused by the nine HPV types covered by the medication.
This is the first step in ensuring women and men older than 26 will have access to the vaccine, and specifically that it will be covered by insurance said Dr. Linus Chuang, chairman
of Obstetrics and Gynecology with the Western Connecticut Health Network.
The FDA approval doesn’t require insurance companies to cover the shot, he said, but most will likely begin doing so in the next year. This can be especially important for lower income people in that age group who may not have been able to afford the $450 to get the vaccine before, he said.
”Cervical cancer is actually a cancer of the underserved people,” Chuang said. “They will really benefit by expanding the insurance coverage so older people can get it.”
Chuang added that when the vaccine first became available for the younger age group in 2006, there were many people hesitant to get it because of concerns about side effects. Parents also feared the vaccine would promote promiscuity.
But in the 12 years since, people have become more educated that this is not the case and have learned that
the vaccine has no major side effects. Expanding the age range means those who decided against it when they were under 26 could get it if they change their mind, he said.
“"Those people who never had it are now in their
20s, so now they can get it,” Chuang said. "They missed that time period and now they have an opportunity.”
Chuang, Saul and others said the expansion is a great thing, and should prevent more people from getting certain kinds of cancers.
“We know that HPV is the causative virus to many vaginal, penile, rectal and oral cancers,” said Dr. Michael Kessler, an obstetrician-gynecologist affiliated with Griffin Hospital in Derby. “(Expanding the age range) made clinical sense.”
According to CDC, about
14 million Americans become infected with HPV annually, and nearly 80 million Americans have the infection, making it the most common sexually transmitted disease. It can be contracted by oral, anal or vaginal sex with an infected person.
The CDC reports that about 20,260 cancers in women and 13,477 cancers in men every year are likely linked to HPV. These include cancer of the cervix (roughly 90 percent of which is probably caused by HPV), as well as cancer of the vagina, penis, anus, vulva and oropharynx, which is part of the throat.
In Connecticut, the CDC reports, about 11.7 people in
100,000 were diagnosed with HPV-associated cancers between 2011 and 2015.
Gardasil was originally approved by the FDA in
2006 to prevent four types of HPV. It is no longer used in the U.S. Instead, in 2014, the FDA approved Gardasil
9, which added protection against five more HPV types.
CDC research has shown that the HPV vaccine prevented 90 percent of cancers linked to the illness — which equated to roughly
31,200 cases every year — in people 9 to 26.
The FDA states that it partly based the decision to expand the age range on a study that followed about 3,200 women from 27 to 45 years old for three and a half years. The study that Gardasil was 88 percent effective in preventing “a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions and cervical cancer related to HPV types covered by the vaccine.”
Chuang said these results were particularly exciting because it was previously believed that the vaccine wouldn’t work for those who already had an HPV infection or had already had sex.
”Even though we give it to older people and very likely many of them already have HPV infections, they still are 88 percent effective at preventing these cancers,” he said. ”That is really amazing. It gives us a lot of hope in preventing cancer.”