The U.S. Food and Drug Administration wants more information before it considers approving the cervical cancer vaccine Gardasil for women ages 27 to 45, drug maker Merck & Co. said Wednesday. The company had expected FDA approval by next month.
Merck spokeswoman Kelley Dougherty wouldn't reveal the nature of the FDA's questions but said the company will respond to the agency next month, Bloomberg news reported.
Gardasil protects against human papillomavirus (HPV), which can cause cervical cancer later in life. According to a Merck-sponsored study, Gardasil prevented 91 percent of precancers and external genital lesions in women ages 24 to 45.
The FDA's concerns about the use of the vaccine in older women don't affect Gardasil's approved use for girls and women ages 9 to 26, Bloomberg reported.