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As health plans elect to cover a new FDA-approved vaccine that protects girls and women against strains of the human papillomavirus (HPV), parents might wonder if it will be mandated by states as a routine immunization for girls at a certain age.
Currently on the market is Merck's Gardasil, which protects recipients against four types of HPV that cause 70% of cervical cancer and about 90% of genital warts. The vaccine is administered in three doses over six months and costs $360; however, many insurers are covering it. Cervarix, manufactured by GlaxoSmithKline, anticipates FDA approval this year.
Lynn Nishida, manager, clinical pharmacy services for Portland, Ore.-based Regence, says there are still too many issues surrounding the use of Gardasil before it becomes a part of routine vaccinations-how long the vaccine is effective; whether males can benefit from it; the effectiveness of the vaccine after a female becomes sexually active; the fact that Gardasil, while highly effective, does not totally eliminate diseases associated with HPV; and finally, that the vaccine does not replace the need for periodic/routine cervical screenings. In addition, there is a lack of long-term data on and experience with the vaccine.
Besides ACIP, the American Cancer Society and the American Academy of Pediatrics support girls' receiving the vaccine, as well as coverage of the vaccine by states and private insurers. The organizations, however, have not shown support for state requirements for the vaccine.
California Assemblymember Ed Hernandez (D-Baldwin Park) has proposed legislation (AB 16) that would mandate the vaccine for girls before they enter the sixth grade. California is one of at least 25 states debating that very question.
Texas Governor Rick Perry has issued an order for girls entering sixth grade to be vaccinated with Gardasil, starting in 2008. Gov. Perry also directed state officials to make the vaccine available free to girls 9 to 18 years, who are not covered by insurance or whose insurance does not cover the vaccine, and that Medicaid offer Gardasil to women ages 19 to 21. Some conservatives and parents' rights groups worry that requiring girls to get vaccinated would condone premarital sex and interfere with the way they raise their children.
The Campaign for Children and Families, a California-based pro-family organization, recognizes the importance of the vaccine but would rather see, says the groups president Randy Thomasson, "a caring and sensitive policy that would offer, not mandate, the HPV vaccine, and would include education on the risks of unmarried sexual contact."
To date, the California Department of Health Services has distributed 60,000 doses of the vaccine to healthcare providers and expected to provide an additional 45,000 doses in February. In addition, although California Governor Arnold Schwarzenegger has not yet taken a position on the legislation, he has included $11.3 million for HPV vaccines in his fiscal year 2007-2008 budget proposal.
Gardasil manufacturer Merck & Co., Whitehouse Station, N.J., has relationships with lobbyist groups, among them Women in Government, a non-profit, bipartisan organization of female state legislators.
THE VALUE OF VACCINATIONS
"Vaccinations are among the most cost-effective medical interventions," says John Clymer, president of Partnership for Prevention, a non-profit, non-partisan health policy organization in Washington, D.C. "For every dollar invested in childhood vaccines, there is a payback," he says. "It dramatically will reduce the number of people who will have to endure the anxiety, discomfort and cost of follow-up exams, as well as false positives if they are not vaccinated before they are sexually active."
He emphasizes, however, that just because a girl is already sexually active, the vaccine still can be effective.