FDA ex­pands age range for HPV vac­cine

The News-Times - - FRONT PAGE - By Amanda Cuda and Anna Quinn

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.”

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