FDA Approves Vaccines for HPV-Related Disease
Agency approves the use of Gardasil in males and new vaccine Cervarix for females
MONDAY, Oct. 19 (HealthDay News) -- On Oct. 16, the U.S. Food and Drug Administration approved two vaccines to prevent diseases related to human papillomavirus (HPV) in males and females.
The FDA had previously approved one of the vaccines, Gardasil, for use in females ages 9 to 26 years to prevent several types of cancer, precancerous lesions, and genital warts caused by certain strains of HPV. On Oct. 16 the agency approved the use of Gardasil in males ages 9 to 26 years for the prevention of genital warts caused by HPV types 6 and 11.
Also on Oct. 16, the FDA approved use of the new vaccine Cervarix in females ages 10 through 25 years. The vaccine is used to prevent cervical cancer and precancerous lesions caused by HPV types 16 and 18. These two HPV types cause about 70 percent of cervical cancers worldwide. According to the National Institutes of Health, there will be 11,270 new cases and 4,070 deaths from cervical cancer in the United States this year.
"The licensure of Cervarix adds another option in the prevention of cervical cancer. It has the potential to save lives from cervical cancer as well as reduce the need for biopsies and invasive procedures associated with the necessary follow-up from abnormal Pap tests," Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research in Silver Spring, Md., said in a statement.