FDA Approves Gardasil for Additional Types of HPV
Vaccine adds protection against five additional HPV types -- 31, 33, 45, 52, and 58
WEDNESDAY, Dec. 10, 2014 (HealthDay News) -- The Gardasil 9 vaccine has been approved by the U.S. Food and Drug Administration to treat five additional types of human papillomavirus (HPV), the FDA said Wednesday.
The approval covers females ages 9 through 26 and males ages 9 through 15, the agency said in a news release. The additional types of HPV -- 31, 33, 45, 52 and 58 -- cause about 20 percent of cervical cancers and weren't covered by prior approvals of Gardasil.
In a study of 14,000 females ages 16 through 26, Gardasil 9 was 97 percent effective in preventing cervical, vulvar, and vaginal cancers caused by the five additional HPV types. The vaccine is given as three separate shots within six months. The most common side effects reported during clinical evaluation included pain, swelling, and redness at the injection site and headache.
"Vaccination is a critical public health measure for lowering the risk of most cervical, genital, and anal cancers caused by HPV," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. "The approval of Gardasil 9 provides broader protection against HPV-related cancers."
The vaccine is manufactured by Merck, based in Whitehouse Station, N.J.