Many States Are Moving to Require HPV Vaccination for School Entry

In the face of a growing number of states taking up legislation that calls for vaccination of preteen girls against the human papillomavirus, or HPV, as a requirement for school entry, the Academy has adopted a more cautious tone, saying it's too early to consider mandating the vaccine in the absence of more definitive data about its use and a better understanding of the logistical issues involved in making it available to this sizable patient population.

A policy statement developed by the AAFP Commission on Science and approved Feb. 7 by Board Chair Larry Fields, M.D., of Flatwoods, Ky., laid out the Academy's reservations about taking such a hard-line stance, saying it was "premature to consider school entry mandates for HPV vaccine until such time as the long-term safety with widespread use, stability of supply and economic issues have been clarified."

The Academy's policy draws in part from a June 2006 statement (PDF file: 2 pages / 28 KB. More about PDFs.) from the Association of Immunization Managers on immunization requirements in school and day care settings.

At the same time, the AAFP continues to promote its clinical recommendation for administration of the vaccine, which was included in the Recommended Adolescent Immunization Schedule 2007 (PDF file: 1 page / 89 KB. More about PDFs.) jointly developed by the CDC's Advisory Committee on Immunization Practices, or ACIP, the AAFP, and the American Academy of Pediatrics and released Jan. 2.

The Academy's position is right where it should be -- on the side of hard science, says AAFP President Rick Kellerman, M.D., of Wichita, Kan.

"We're all concerned about the human papillomavirus and its relationship to cervical cancer," Kellerman said. "The Academy has historically followed the ACIP recommendations as published in MMWR (Morbidity and Mortality Weekly Report).

"But there's a difference between recommending this vaccine -- sitting down and talking with your patients or, in this case, their parents, about the vaccine, its benefits and risks and other unknowns, and helping them make a decision -- and having a state law mandate the vaccine."

At issue is the quadrivalent HPV vaccine, Gardasil, approved last June for use in female patients ages 9-26 years to prevent infection caused by HPV types 6, 11, 16 and 18. Those HPV types are estimated to cause about 90 percent of genital warts; types 16 and 18 account for about 70 percent of cervical cancers.

According to the latest figures from the American Cancer Society, more than 11,000 cases of invasive cervical cancer will be diagnosed in American women in 2007, and nearly 3,700 women will die of the disease. And some researchers estimate noninvasive cervical cancer to be four times as common as invasive forms of the disease.

Those statistics have state lawmakers across the country pursuing legislative measures that would require adolescent girls to complete the three-dose HPV vaccine series as a prerequisite to attending school. At press time, about 20 states had legislation related to HPV vaccine mandates pending.

"For legislators, it’s a piece of feel-good legislation," said Diana Ewert, AAFP senior manager for state government relations. "They can respond to their constituents that they support pro-health legislation. But it's unfortunate for our chapters that something like this (legislative mandate) gets thrown into the mix.

"Because of the nature of the vaccine, opt-out provisions in the legislative mandates are more broad. An unintended consequence could be that anti-vaccine groups insist that the provisions be applied to all school-mandated vaccines," said Ewert. "This would certainly be a concern for public health officials."

On Feb. 2, Texas became the first state to put a mandatory HPV immunization statute on the books, thanks to Gov. Rick Perry, who bypassed the Texas Legislature and issued an executive order mandating administration of the vaccine. Perry's order, which takes effect Sept. 1, 2008, requires all 11- or 12-year-old girls to be immunized against HPV before they can enter the sixth grade.

In a statement issued Feb. 5, Perry defended his action. "Providing the HPV vaccine doesn’t promote sexual promiscuity any more than providing the hepatitis B vaccine promotes drug use," he said, further noting that parents "have the final decision about whether or not their daughter is vaccinated."

Some clinicians have voiced concerns that young women may view the vaccine as offering "permission" of another sort, however. Namely, that women will choose to forgo appropriate Pap screening, thinking they no longer have a need for the tests.

All the more reason to put off mandating the vaccine, said Kellerman, pointing to the difference between efficacy trials conducted under highly controlled circumstances and the larger, real-world effectiveness trials needed to accumulate reliable data on issues such as vaccine safety and immunogenicity.

"Right now, when we don't have long-term safety data and we've had only an intermediate end point -- abnormal pap smears -- we don’t favor mandating the vaccine, but this does point out the need for continued surveillance and research," said Kellerman. "Perhaps five or 10 years down the road, for example, we may want to take a new look at Pap smear frequency recommendations. But right now, we know this vaccine does not protect against all the virus types that cause cervical cancer, and we don't know how long it will last. We still have a lot to learn.

"There may be a time, when we have better postmarketing surveillance, that we think about mandating it. But it's premature to make that decision now," said Kellerman.

Moreover, he added, FPs and other clinicians are rightfully raising practical concerns about how the vaccine is going to be used -- how it will be stored and delivered, for example, and whether the supply will be adequate to meet demand. Another key issue, of course, is who will pay for patients to get it.

In fact, it's covering the cost of the vaccine series that has some stakeholders -- including those who fully acknowledge the vaccine's merits -- bristling at the notion of school mandates.

It has been estimated that a universal school entry requirement for the vaccine would come at a cost of approximately $900 million per year to provide coverage for the female birth cohort (2 million girls: $120 per dose plus $25 administration fee; three doses). Such a mandate would place a significant burden on state public health budgets, said the AAFP Commission on Science in making its policy recommendation.

In a nod to cost concerns, Texas' Perry included provisions in his order making the vaccine available to 9- to 18-year-olds through the Vaccines for Children Program and to 19- to 21-year olds via Medicaid.

It's worth noting, too, that the vaccine's manufacturer, Merck and Co., has established the Merck Vaccine Patient Assistance Program to offer eligible adults help in covering the cost of this and other Merck vaccines.

As for private payers, most major insurers with plans that cover preventive services will cover the HPV vaccine as an ACIP-recommended immunization, according to AAFP private sector advocacy specialist Trevor Stone. But there likely will be geographic and other differences in how complete that coverage is across the various payers, he noted.

Still, for Kellerman, the whole HPV vaccine mandate issue has raised some interesting and important questions about the appropriate role of immunizations in safeguarding patients' health.

"Our hope is that this introduces a new era in which we have vaccines that protect against not only communicable respiratory diseases but also protect against cancer," he said.