Mandatory HPV Vaccination 'Presents Ethical Concerns,' Likely 'Counterproductive,' JAMA Editorial Says

Although human papillomavirus infection and cervical cancer associated with HPV are "significant national and global public health concerns," mandatory HPV vaccination among middle-school age girls "presents ethical concerns and is likely to be counterproductive," Lawrence Gostin of Georgetown Law Center and Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, write in a JAMA editorial (DeAngelis/Gostin, JAMA, 5/2).

Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. GSK last month announced that it has filed for FDA approval of Cervarix (Kaiser Daily Women's Health Policy Report, 4/23).

According to DeAngelis and Gostin, the effort to make the vaccine mandatory "contributes to long-standing parental concerns about the safety of school-based vaccinations" and has the "unintended consequence of heightening parental and public apprehensions about childhood vaccinations." Mandatory HPV legislation has "undermined public confidence and created a backlash among parents," the authors write, adding, "Public health authorities, pediatricians and infectious disease specialists, rather than political bodies, should drive mandatory vaccination decisions and policies."

Another concern surrounding mandatory HPV vaccination is how vaccine recipients "would be compensated if they incurred serious adverse effects" from a vaccine the state required. According to the authors, the vaccine is "supported by limited efficacy and safety data" and "still need[s] to be evaluated among a large population, and particularly among younger girls." DeAngelis and Gostin write that the HPV vaccine "is not immediately necessary to prevent harm to others," concluding that in the absence of such an "immediate risk of serious harm, it is preferable to adopt voluntary measures, making state compulsion a last resort" (JAMA, 5/2).

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View drug information on Cervarix [Human Papillomavirus Bivalent; Gardasil.