ROCKVILLE, Md. June 8 — The FDA today approved Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18] recombinant vaccine) for prevention of cervical cancer and for prevention of cervical, vulvar and vaginal pre-cancers caused by HPV types 16 and 18.
The agency said the vaccine, made by Merck, was approved for immunization of girls and women ages nine to 26. The vaccine was not approved for immunization of boys, however, a blow to the cancer prevention community that had campaigned for approval in both boys and girls.
Nonetheless, the approval marked the first time the FDA has approved a vaccine to prevent cancer.
"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," said Andrew C. von Eschenbach, M.D., Acting Commissioner of Food and Drugs.
Earlier this week Robert F. Ozols, M.D., Ph.D., senior vice president of the medical science division at Fox Chase Cancer Center in Philadelphia, said widespread use of the vaccine could be "a transforming event that could wipe out cervical cancer."