An important public health milestone was reached last week when FDA approved a vaccine that prevents infection by the two types of the human papillomavirus (HPV) responsible for up to 70 percent of cervical cancer cases worldwide, HPV 16 and HPV 18, as well as two other HPV types, HPV 6 and HPV 11, that cause benign genital warts.

Our nation's strong commitment and investment in cancer research at NCI led to this approval, something in which we all can take great pride. NCI investigators throughout the institute were involved in the discovery that HPV causes cervical cancer. Most prominent among NCI scientists working on this project were Drs. Douglas Lowy and John Schiller of the Center for Cancer Research (CCR). They also were instrumental in the discovery of the virus-like particle technology that led to the vaccine's development.

Called Gardasil and manufactured by Merck & Co., this vaccine will provide a significant boost to NCI's efforts to reduce the burden of disease by eliminating the need for invasive procedures to remove many precancerous lesions. But its impact will likely be greatest in developing countries where a lack of public health infrastructure and screening programs results in hundreds of thousands of lives lost each year to cervical cancer.

There is much more to come in our efforts against cervical cancer. At the policy level, the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP), an independent panel of scientific advisors that offers guidance to CDC on the development of immunization guidelines, is expected to make its recommendation on Gardasil's use at its next meeting on June 29.

Critical research also is ongoing. A second HPV vaccine that also protects against HPV 16 and 18, manufactured by GlaxoSmithKline and called Cervarix, is being tested in phase III clinical trials. And NCI's Division of Cancer Epidemiology and Genetics researchers, led by Drs. Alan Hildesheim and Mark Schiffman, in collaboration with investigators in Costa Rica, are conducting a clinical trial in that country to evaluate the safety, efficacy, and other performance characteristics of the HPV type 16 and 18 vaccine.

Continued research is essential because there are important questions that remain to be answered. For instance, although the studies conducted to date indicate that protection lasts at least 4 years, the ultimate duration of immunity is still unknown, so the vaccine trial participants will continue to be followed.

Meanwhile, next-generation HPV vaccines are under development. At the University of Colorado, with support from NCI's Division of Cancer Prevention's Rapid Access to Preventive Intervention Development, or RAPID, program, a vaccine is being developed that protects against HPV 16, the predominant contributor to cervical cancer among HPV types. The vaccine is stable at room temperature, meaning it would not have to be refrigerated for storage or distribution. Human clinical trials of the vaccine could begin in 2007.

Researchers also are developing a vaccine that protects against more HPV types, and NCI is collaborating with other researchers on therapeutic HPV vaccines to prevent cancer among women previously exposed to the virus.

The news of this approval allows us to stress the continued importance of cervical cancer screening. And it provides an opportunity to educate the public about the tremendous work cancer researchers are engaged in to develop preventive and therapeutic cancer vaccines.

The entire cancer community should be elated and proud. This approval is a watershed moment that highlights the very best of biomedical research: the translation of basic and population science into an intervention that will save hundreds of thousands of lives.

Dr. John E. Niederhuber
Acting Director,
National Cancer Institute