NEW YORK (WOMENSENEWS)--Merck, the maker of the HPV vaccine Gardasil, said last month that it has sold 750,000 doses since June, when the Food and Drug Administration approved it for marketing to girls and women aged 9 to 26.
Even with this strong uptake, Dr. Richard M. Haupt, executive director of medical affairs at the vaccine division of Merck, based in Whitehouse Station, N.J., worries that one group that should be getting the vaccine may be missing out: sexually active women between 18 and 26.
"Everyone is confused about what to do with this sexually active population. The answer is: Vaccinate them," says Haupt.
Kelley Dougherty, director of public affairs for Merck vaccines, says she is hearing from sales representatives that doctors are confused about the eligibility of the 18-to-26 demographic for Gardasil.
"If you look at the Advisory Committee on Immunizations Practices Web site you will see that there is very specific language to tell providers to vaccinate patients up to age 26, but it's still not a clear message at this point."
Meanwhile, some clinicians say the high price of the vaccine--administered in three doses over a six-month period--is giving many young women ages 18 through 26 further pause about whether they should get the vaccine.
The HPV vaccine is the first vaccine against a sexually transmitted disease to join the list of immunizations recommended for children by the Centers for Disease Control and Prevention in Atlanta. With a total price tag of roughly $360, Gardasil is the most expensive recommended vaccine to date, says Dr. Lance Rodewald, director of immunization services at the CDC.
Dr. Christine Peterson, director of the gynecology clinic at the University of Virginia in Charlottesville, says the biggest deterrent to female students at the school who are seeking the vaccine is its cost. Her clinic is running Gardasil clinics twice a week and has vaccinated over 100 women so far this year.
"The cost came as a real blow," attests Elizabeth Martin, a 26-year-old master's candidate in psychology in New York City, whose name has been changed to protect her privacy, and who has begun taking the vaccine. "It's a three-part vaccine that my doctor charged $180 per dose for, and my college health plan wouldn't reimburse me for it."
Sources of Confusion
One source of the confusion about vaccinating women is that vaccines are usually only administered before exposure and some women at the older age of the recommended age bracket are already sexually active and have been exposed to the virus.
However, HPV has dozens of strains, so the vaccine may be effective against strains that have not yet infected the women.
Part of the confusion also stems from the vaccine's primary population target, those who qualify for childhood vaccination programs.
On Nov. 1, for instance, the government recommended that Gardasil--the trademark name for the vaccine--be added to its Vaccines for Children program, a division of the CDC that provides vaccines to children though age 18 who are also Medicaid-eligible, uninsured, underinsured or Native American.
But the government's age cutoff of 18 does not match the recommendations for this vaccine.
The CDC says the ideal window for vaccination is between 11 and 12, but that it can be administered on a "catch-up" basis through age 26.
"This means that a 16, 18 or 26-year-old women can get the vaccine," says Curtis Allen, a spokesperson for the CDC.
Merck reports that in its latest survey of insurers, 90 percent of insurance companies said they plan to cover the vaccine.
However, a coverage lag now seems to be affecting young women who are not covered by the government's Vaccines for Children program.
Private insurers may eventually reimburse members who pay for the vaccine out of pocket, but so far the CDC's Rodewald says he doesn't know of any insurance company that has activated coverage.
"The good news is that insurance companies usually end up covering the vaccines that we recommend," says Rodewald. "It often just takes a while--sometimes over a year--for insurance companies to implement coverage."
Rodewald advises young women to lobby their insurance providers. "That's one of the ways to expedite the process."
Amy Allina, a spokesperson for the Washington-based National Women's Health Network, an independent health organization, says she doesn't know of any organized effort to lobby the insurance industry for coverage yet.
"But I think that is because people are optimistic that it will be covered," Allina said. "If that turns out not to be the case, I'm sure we'll see efforts to organize patients who have been denied coverage."
HPV is short for human papillomavirus, a group of over 100 viral strains. Two strains cause 90 percent of genital warts, and two other strains cause 70 percent of cervical cancer cases.
If a cancer-causing strain is left untreated, it can lead to cervical cancer, the second most common cause of cancer death in women worldwide.
Gardasil vaccinates against four of the cancer-causing strains, which cause 70 percent of cervical cancer, according to Merck.
Pap Smears Still Needed
Because the vaccine does not prevent every form of the disease, health officials stress the importance of yearly pap smears, even for girls and women who have been vaccinated.
At least 1 in 3 sexually active young women has had a genital HPV infection and Merck estimates that 80 percent of U.S. women will have had an HPV infection by age 50.
Martin, the New York psychology graduate student, personally encountered clinical confusion about the vaccine.
She says her school health clinic didn't have the vaccine, but that she was advised in any case that she did not qualify to receive it for three reasons.
"They told me I wasn't eligible for it because I was 26 years old, sexually active and had tested positive for a strain of the virus," she says.
Only after Martin had an abnormal pap smear and her school clinic referred her to a specialist did she begin getting the vaccine.
To fill in the gaps with both students and providers, Merck's Dougherty says the company is looking for ways to partner with campus social organizations--primarily sororities--to get information out to students and providers.
Hannah Seligson is a freelance writer based in New York. Her book, "New Girl on the Job," will be published by Citadel Press in 2007.
For more information:
Merck's Cervical Cancer Center:
Centers for Disease Control, HPV Information:
National Women's Health Network:
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