The Food and Drug Administration (FDA) has announced the approval of the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16, and 18. The vaccine, which carries the brand name Gardasil, is approved for use in females 9 to 26 years of age. Gardasil was evaluated and approved in 6 months under FDA's priority review process. This month, "Closing Thoughts" shares comments about the vaccine from leaders in the oncology community.
American Society of Clinical Oncology
"Today's FDA approval of the HPV vaccine is a major advance for cancer prevention, and for women everywhere. The HPV vaccine has the potential to dramatically reduce the toll of cervical cancer in the US and worldwide, and even opens up the possibility of eliminating a cancer in our lifetime. Critical to success will be ensuring that women in the world's poorest countrieswhere cervical cancer hits hardesthave rapid and affordable access to this life-saving new tool. The development of this vaccine demonstrates the importance of investing in cancer prevention research."
Gabriel Hortobagyi, MD
National Cancer Institute
"This vaccine opens a new era in cancer prevention. It has the potential to save women's lives, as well as to reduce health disparities in the United States and around the world. NCI's immunology and vaccine research regarding HPV infection is far from finished. We continue to work on improved vaccines and immunization technology, to make these prevention strategies even more effective and accessible to women worldwide."
John E. Niederhuber, MD
Acting Director, NCI
"Genetic engineering. . .was used to create this vaccine, which is made up of noninfectious virus-like particles (VLPs). These hollow spheres, formed by a single protein from the virus (L1 protein), trigger an antibody response that is capable of protecting the body against infection by the targeted virus types."
Douglas Lowy, MD
Chief, Laboratory of Cellular
Oncology, NCI's Center
for Cancer Research/p>
Cancer Research and Prevention Foundation
"The approval of the first vaccine to protect against the human papillomavirus, the virus that causes most cases of cervical cancer, is a true milestone in cancer prevention. With widespread administration, the lives of thousands of women in the United States and hundreds of thousands worldwide could be saved each year. The Cancer Research and Prevention Foundation is optimistic that this is the first of many novel vaccines that will reduce the burden of cancer, attacking this devastating disease on the front end before it claims lives."
Carolyn R. Aldigé
President and Founder, CRPF
US Food and Drug Administration
"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers. The development of this vaccine is a product of extraordinary work by scientists as well as by FDA's review teams to help facilitate the development of very novel vaccines to address unmet medical needs."
Andrew C. von Eschenbach, MD
Acting Commissioner, FDA
"This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA's commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults."
Jesse Goodman, MD, MPH
Director of FDA's Center for
Biologics Evaluation and Research
American Cancer Society