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The new vaccine for human papillomavirus (HPV) is challenging the way nurses — and the public — think about vaccines, governmental mandates, and HPV's classification as a sexually transmitted disease.

The U.S. Food and Drug Administration approved Gardasil, manufactured by Merck & Co., to prevent HPV. The vaccine protects against four types of HPV, two of which are responsible for the majority of cervical cancer deaths.

The CDC estimates that an average of 233,000 women in the world die of cervical cancer each year. In 2004, the U.S. saw 10,500 cervical cancers diagnosed and 3,900 cervical cancer-related deaths.

But these figures don't tell the whole story. Not only can HPV cause cervical cancer, it is also associated with millions of cases of genital warts and cervical dysplasia — a precancerous condition that has high physical, emotional, and monetary costs.

In addition, HPV causes various percentages of the total number of cases of less common cancers, including penile (90%), anal, vulvar, and vaginal, says Dartmouth Medical School Professor Diane Harper, MD, MPH, MS, one of the chief investigators on the multinational trials for Gardasil and Cervarix, a similar vaccine manufactured by GlaxoSmithKline that is expected to be licensed within a year.

Education campaign needed

Clinicians need to have a thorough understanding of the vaccine's risks and benefits in order to counsel patients and their families about the vaccine. Patricia Gerrity, RN, PhD, FAAN, director of Drexel University's 11th Street Family Health Services in Philadelphia, intends to hold an HPV education session for all staff workers at the center.

"It's a wider group than nurse practitioners who educate our clients. The outreach worker, the social worker, they have a lot of influence, and our clients often ask them questions that they wouldn't ask us. So, no matter who — the van driver, the nutritionist, the health educator — everyone should be up on the vaccine," says Gerrity, who is also associate dean for community programs at Drexel's College of Nursing and Health Professions. Gerrity has recently written a grant proposal seeking funds for teen-only hours at the health center, during which adolescents could learn about various health and wellness issues, including the new HPV vaccine.

A stealthy virus

Many carriers don't know they have HPV, since the body often can fight it off without symptoms. People can contract HPV, recuperate, and get it again. It is the most common sexually transmitted virus, and it is startlingly widespread. According to the CDC, 80% of women over age 50 will have carried some type of HPV at some point in their lives.

But women are not alone in harboring the virus; males and females of all ages are at risk. "Ten percent of the [total] population at any given time, no matter what age they are — 3, 11, or 72 — will have high-risk, cancer-causing HPV types," Harper says.

"When you start to understand the magnitude of the problem, you realize how incredibly powerful the vaccine is," Harper says. "This is a really, really common virus that most people will have at some point in their lives."

Health leaders support vaccine ...

After the FDA granted its approval, the CDC's Advisory Committee on Immunization Practices (ACIP) unanimously recommended that the vaccine be routinely given to girls and women 11 to 26 years old and to 9- and 10-year-olds whose doctors recommend it. Many national and state public health organizations, including the American Cancer Society, the American Academy of Pediatrics, and The American College of Obstetricians and Gynecologists also quickly recommended its use.

In addition, ACIP recommended that Gardasil be added to the list of vaccines in the Vaccines for Children (VFC) program — a federal initiative that provides free vaccines to children in need. The vaccine's approval for use in the VFC program does not make it mandatory for children entering school. Such decisions are made by each state. In recent months, more than 20 states introduced legislation related to the vaccine (see sidebar, "Pending legislation," on facing page), creating a flurry of media attention.

... But public is wary

Intense lobbying efforts by Gardasil's manufacturer Merck & Co. prompted many states to consider mandating the vaccine. While it is common practice for large corporations to lobby state and federal lawmakers in support of their products, Merck abruptly withdrew from its lobbying campaign Feb. 20. The company's medical director explained at the time that public outcry claiming the vaccine promoted sexual promiscuity was a distraction from the company's goal to prevent cervical cancer.

HPV's classification as a sexually transmitted disease belies the fact that it also is transmitted by various skin-to-skin contacts. For instance, HPV living under the tips of the fingernails can easily get into the nose (especially the noses of children, for example) and remain there for years.

"This is a virus that causes cancer in every part of our bodies that are moist, wet skin," Harper says. "Moist epithelium is at risk."

Administering the vaccine

Gardasil vaccination entails a three-part series of intramuscular injections over a six-month span. Together, the three injections prevent nearly 100% of the high-risk, cancer-causing infections caused by HPV types 16 and 18 and 90% of cervical warts, which are caused by HPV types 6 and 11. The vaccine does not contain any live virus, mercury, preservatives, eggs, or DNA. The only adverse reactions reported by study participants have been mild or moderate pain and tenderness at the site of the injection.

The vaccine is not a cure-all, however. It protects against only four of the nearly 100 types of HPV that exist. Therefore, even vaccinated women must continue to have Pap screenings.

"I think some people might be misled to think it's total prevention and they don't still need to get a Pap, which of course they do," Gerrity says. "They also have to realize they still need to protect themselves against other STDs."

Wendy Grube, MSN, CRNP, associate director of the Women's Health Care Nurse Practitioner Program at the University of Pennsylvania in Philadelphia, says she was concerned when she heard a physician say the vaccine would make the Pap test a thing of the past.

"We don't want people lured into a false sense of security that if they get immunized they no longer need follow-ups," Grube says. "That truly cannot happen."

Who should get it

Amy Middleman, MD, MPH, MSEd, an associate professor of pediatrics at Texas Children's Hospital, consulted with the CDC advisory committee as it made its recommendations about the vaccine. To respond to parents who say their daughters don't need the vaccine because they are not sexually active, Middleman suggests talking about its role as a preventive agent.

"It is very important to give it prior to any sexual activity," she says. "Because we know that she will most likely become sexually active at some later time, it's very important to protect her ... well before that time."

Harper suggests linking vaccination with the onset of puberty — rather than the onset of sexual activity. "It's a much nicer way to do it," she says. "When a girl needs to buy her first bra, that's a good time to get the vaccine."

Besides the recommendation for younger girls, ACIP advises that females aged 13 to 26 get a "catch-up" vaccine.

"I think it's something that every woman should look at, even if you're 50," says Jane Dimmitt Champion, FNP, PhD, of the Uvalde Family Practice, a rural community health center and an associate professor in the department of family nursing at the University of Texas Health Science Center at San Antonio.

Reaching the underserved

Perhaps the biggest challenge Gardasil and Cervarix present will involve distribution to underserved populations. Among other barriers, the cost of the three-vaccine series is about $360.

As a participating member of the state- and federally funded Vaccines for Children (VFC) program, Drexel's health center will dispense Gardasil at no cost. But VFC covers children only until age 18, which is particularly worrisome for the health center's North Philadelphia population.

"The majority of our client base are African-American women living well below the poverty line ... and have the highest mortality rate from cervical cancer," Gerrity says. Some women who are too old for the VFC program might be covered by state medical assistance, but many are not, she says.

The question of who will pay for the HPV vaccine will be the next challenge for public health advocates.

Joan Wilder is a freelance writer. To comment on this story, e-mail dnovak@gannetthg.com.