Bad News for Older Women Who Want the HPV Vaccine

FDA approval has been delayed. Should you get it anyway?

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There was some disheartening news on the HPV vaccine today for women ages 27 to 45 who were hoping to get vaccinated against cervical cancer and have the $360 cost covered by insurance. The Food and Drug Administration told manufacturer Merck that it needs more time to make a decision about expanded use for its Gardasil vaccine, already approved for females ages 12 to 26. The vaccine protects against four HPV types, two of which cause genital warts and two of which are responsible for 70 percent of cervical cancers; about 80 percent of women become infected with HPV at some time or other.

In a previous blog, I discussed the seemingly arbitrary age limit placed on this vaccine and how many doctors were already giving it to women ages 27 and over. At that time, gynecologist Diane Harper, a professor of women's and gender studies at Dartmouth College who conducted some of the HPV vaccine trials, told me she was concerned that the vaccine, which had been tested only in women up to age 26, wasn't approved for those ages 27 and above. "It's absolutely artificial to say that we shouldn't vaccinate older women," she said, or that the vaccine is effective for virgins only. Half of the women she inoculates are in or approaching middle age, and many are hitting the dating scene again after divorcing or becoming widows.

I also noted the potential for expanded inoculation to prevent cervical cancer in older women:

Although the vaccine doesn't do any good against active infections, HPV goes away on its own about 75 to 95 percent of the time. That means women can get infected, have the virus clear from their system, and then get infected again. In fact, British research found that 21 percent of women in their 50s, who were HPV free at the beginning of the study, tested positive for the virus three years later. The potential benefits of expanding vaccination are huge. Statistical models show that if all females ages 12 to 26 were given the vaccine, the incidence of cervical cancer would be reduced by half in 25 to 30 years; adding women to age 55 would achieve the same result in a decade.

I hope that the FDA and Merck resolve these issues soon. I'm also crossing my fingers that another HPV vaccine, called Cervarix, will soon be approved by the FDA. It has been tested in women up to age 45, so it could be approved for a larger age group. Cervarix is the HPV vaccine of choice in Great Britain, but the FDA delayed its approval in the United States last December, seeking more information on the trial data.