For Kari Lange, getting the human papillomavirus vaccine for her daughters, Erika, 16, and Darcy, 13, was a no-brainer. After all, the new vaccine is considered one of the most effective methods for preventing cervical cancer and genital warts. And the Lincolnshire, Ill., mom knew firsthand that even if the virus, which is transmitted through sexual contact, never progresses to cervical cancer, it is no picnic. She and her sister both contracted it when they were younger. "To me it wasn't even about sex," says Lange about having her daughters vaccinated. "It was just healthy for the kids."
The Food and Drug Administration approved Merck's human papillomavirus (or HPV) vaccine, Gardasil, in June 2006 for girls and women between the ages of 9 and 26. The U.S. Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists all recommend it. But despite their efforts—and a national ad campaign by Merck urging viewers to be "one less" person with cervical cancer—only two out of every 10 women in the approved age group have gotten the vaccine so far.
Why isn't everyone rushing to get immunized? In interviews with NEWSWEEK, health-care providers cited a variety of issues that may explain the low numbers: the high cost and inconvenience of the required three shots, a lack of awareness about HPV, the low number of regular physician visits among that age group, and parents' unease over immunizing their kids against a disease contracted through sexual activity. If the United States wants to lower the number of women who get cervical cancer each year, health officials say they must overcome those barriers. But it won't be easy.
Part of the problem is that—despite Merck's multimillion-dollar ad campaign—many patients, and parents, are still not aware of the link between the virus and the cancer. More than one-quarter of American women between the ages of 14 and 59 are estimated to have HPV, according to a study published last year in the Journal of the American Medical Association. But one 2007 study found that only 40 percent of women in the United States had even heard of the virus. And only half of them knew that HPV is the primary cause of cervical cancer. A new survey from the National Association of Nurse Practitioners in Women's Health found that more than 60 percent of women are unaware of any health problems associated with HPV. (In addition to abnormal cell growth, the virus can cause genital warts.)
The HPV vaccine doesn't guarantee that a woman won't get cervical cancer or warts, but it protects against viral types 16 and 18, which cause 70 percent of cervical cancer worldwide, and against types 6 and 11, which cause 90 percent of warts in both men and women. It's still unknown when, or if, immunity will wane and whether women will need to get booster shots later in life. But levels of the antibody to HPV appear to stay high for at least five years. Even if another dose is needed, health officials feel confident that another dose of the HPV vaccine is safe. It's not "biologically possible" to get HPV from the vaccine, which contains no live or killed virus and no viruslike particles, says the University of Michigan's Dr. Amanda Dempsey. The most common side effect has been pain at the injection site, says John Iskander, acting director of the CDC's immunization safety office.
But the vaccine is expensive: it typically costs $360 for three shots taken over six months. "There is a little bit of a sticker shock when they learn the cost," says Dr. James C. Turner, executive director of the department of student health at the University of Virginia and chair of the American College Health Association's vaccine-preventable disease committee. More than 98 percent of privately insured Americans get at least some coverage for the HPV vaccine. But more than 46 million Americans are uninsured, including 27 percent of women ages 19 to 26 (who aren't covered by the CDC's Vaccines for Children program, since they're not under 18).
Health officials say another issue is that the vaccine protects against a virus associated with sexual activity. That makes it tough for some parents to support early immunization. "This is a country that promotes abstinence-only sex ed," says Yale University gynecologist Dr. Mary Jane Minkin.
Even studies of physicians' attitudes toward the vaccine have found that doctors are more likely to recommend the HPV shots for older teens, not tweens, because they're "worried about parental response," says Dr. Jessica Kahn of Cincinnati Children's Hospital Medical Center. "[Yet] to try to predict when your child is going to initiate sex and vaccinate right before then is a very risky proposition."
Ironically, one solution might be to make Gardasil available for even younger kids. Doctors say parents would then be less likely to think of it as a sex-related vaccine. That's what happened with the hepatitis B vaccine, which is now given in three doses before babies are 18 months old. Earlier vaccinations also tend to have a higher compliance rate, since babies and young children typically visit their doctors more regularly than tweens and teens. The 2006 National Immunization Survey showed that 81.3 percent of 13-to-17-year-olds had received three doses of hep B.
For now, health officials are trying to target tweens with the concept of an "adolescent platform" of vaccinations that includes Gardasil. Ideally, preteens would get immunizations like the meningococcal conjugate vaccine (or MCV4), the tetanus, diphtheria, pertussis vaccine (or Tdap) and the HPV vaccine. The federal government's Advisory Committee on Immunization Practices actually recommends that girls be immunized with all three at 11 or 12, and those aged 13 to 26 be given a "catch-up" vaccine.
Young women and girls may not be the only ones to get the vaccine in the future. Merck is also studying the vaccine in men, who in rare cases can get penile cancers, anal cancers and cancers of the head and neck from HPV. The drug company expects to submit data to the FDA on men later this year. And last month it submitted data to the FDA on trials conducted in women up to the age of 45.
Still, the most pressing goal is to increase the vaccination rates among tweens, so they're immunized before they may be exposed to the virus. As awareness of the vaccine and its benefits spreads, there are encouraging signs that a growing number of parents are on board. "Cancer has touched my family," says Diane Simpson-Bundy, a suburban Chicago mom who plans to vaccinate her eight-year-old daughter in a couple of years. "If there's an opportunity to prevent a particular kind of [cancer], I'm all for that."
That's precisely the message health officials hope more parents will hear.