FDA Needs More Data Before Giving Green Light To Gardasil Vaccine For Older Women

Seattle – According to Merck & Co., the Food and Drug Administration has requested additional data for the second time before coming to a decision on approving the expansion of Gardasil, a human papillomavirus vaccine, to be used by older women.

Currently the vaccine is recommended for women ages 9 to 26 years old. Gardasil protects against the sexually transmitted human papillomavirus or HPV that can lead to cervical cancer, genital warts, and other cancers. Merck is requesting approval for the vaccine to be prescribed to women between the ages of 27 to 45 years old.

Last June, the FDA denied the request due to numerous issues related to submitted data not supporting extending Gardasil’s uses to include non-vaccine types of HPV. In response to the denial, Merck gave 24 months of data from a four-year study, illustrating that the goals were met.

Now, the FDA is requesting additional data on a full 48-month study on a test group when it is completed later this year.

Since the effectiveness of Gardasil is lower in older women, Merck may also have a hard time convincing insurers to cover the drug for the older age group if it is approved.

The new request by the FDA does not affect the current supported use of Gardasil or Merck’s other request for Gardasil to be approved for use in males ages 9 to 26. Merck hopes to decrease the occurrence of HPV by preventing the infection among males so they cannot spread it to females during sexual relations.