The Potential of Human Papillomavirus Vaccines
Robert Steinbrook, M.D. The anticipated licensure within the next three months of a vaccine against human papillomavirus (HPV) would represent a major public health advance against cervical cancer and other, less common cancers, including those of the anus, penis, vagina, and vulva. The Food and Drug Administration (FDA) is conducting a six-month priority review of Merck's investigational HPV vaccine and should announce its licensing decision by June 8. Questions remain, however, about the potential behavioral consequences of routinely vaccinating adolescents against a sexually acquired infection, and the public reaction is uncertain.
Genital HPV infection is common, with an estimated 6.2 million new infections each year in the United States. Although most infections are asymptomatic and transient, persistent infection with oncogenic HPV types is a serious health issue. Cervical cancer is the 11th most common cancer among women in the United States — with an estimated 10,370 new cases and 3710 deaths in 2005. There are racial and socioeconomic disparities; more than half of all cases occur in women who have never or rarely been screened. Among women in developing countries, where effective screening programs are often lacking (see page 1110), cervical cancer is the second most common cancer, and a leading cause of cancer-related death.
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<acronym note: federal Advisory Committee on Immunization Practices (ACIP)>
The acceptance of the HPV vaccine — by physicians, parents, preteens, and the public at large — is also uncertain. As with many issues related to sex, people may have strong views. Increased acceptance is likely to require ongoing discussion and educational efforts. At the February ACIP meeting, the conservative Family Research Council, which promotes abstinence before marriage and fidelity within marriage as the best way to prevent sexually transmitted diseases, distanced itself from suggestions that it opposed HPV vaccines.3 Calling such reports "false," the council said it "would oppose any measures to legally require vaccination or to coerce parents into authorizing it" and that "there is no justification for any vaccination mandate as a condition of public school attendance. However, we do support the widespread distribution and use of vaccines against HPV."
Finally, the epidemiology of cervical cancer highlights the need to provide HPV vaccines to persons who may never or rarely be screened, as well as to improve cervical-cancer prevention programs so that they will reach the women with the highest risk of disease.4,5 The HPV vaccine is likely to be considerably more expensive than many recommended vaccines, and its benefits will not be fully apparent for decades. It will be far easier to recommend routine vaccination than to provide the resources for its routine use, in the United States and throughout the world.
Source InformationDr. Steinbrook is a national correspondent for the Journal.
An interview with Dr. Douglas Lowy, chief of the Laboratory of Cellular Oncology at the National Cancer Institute, can be heard at
http://content.nejm.org/cgi/content/full/354/11/1109/DC... References1.Koutsky LA, Ault KA, Wheeler CM, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 2002;347:1645-1651.
2.Harper DM, Franco EL, Wheeler C, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 2004;364:1757-1765.
3.Goodman E. Good news on cancer? Not for everyone. Boston Globe. November 12, 2005:A11.
4.Blumenthal PD, Gaffikin L. Cervical cancer prevention making programs more appropriate and pragmatic. JAMA 2005;294:2225-2228.
5.Schiffman M, Castle PE. The promise of global cervical-cancer prevention. N Engl J Med 2005;353:2101-2104.
http://content.nejm.org/cgi/content/full/354/11/1109
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