There has been talk in the medical world of allowing the administration of Merck & Co’s Gardasil, the cervical cancer vaccine, in older women. Before such a measure is taken, the U.S health regulators, mainly the Food and Drug Administration, have requires longer-term data on a group of older women that have been administered the vaccine before approving its use on this age and gender group.

 

The FDA have sent a lengthy letter to Merck (the second of the kind) in response to their request to expand the use of Gardasil to women over 27 years of age to women aged 45. This is the second time the FDA has declined Merck’s request – last time was in June 2008.

 

However, the FDA is considering agreeing to Merck’s suggestion, yet they required the company to compile significant amount of data that should be gathered over 48 months of continuous case studies. When Merck first forwarded their request to the FDA, they only had gathered data from a study that had lasted for about 24 months. Merck is optimistic about answering the health regulator as quick as the fourth quarter.

 

Currently, Merck’s Gardasil is FDA-approved for use in the cases of women aged 9 to 26. The FDA’s conditions do not affect the administration of gardasil in this younger age group, nor has it anything to do with another request put forward by Merck, regarding the expanding of Gardasil’s usage in men.