Recently, I was asked by a Michigan family lawyer whether Gardasil, Merck & Co’s cervical cancer vaccine, could safely be used by older women. Gardasil was approved in June 2006 for use with females ages 9-26 to prevent cervical cancer and genital warts. Merck had applied for the use of Gardasil in women ages 27 through 45.
It was reported on June 25, 2008 that the FDA has completed its review of Merck’s application and has refused to approve Gardasil for use with older women within the expected review time frame. It is not clear whether this means that there is just a delay or whether the FDA will flat out refuse to approve this usage. Apparently, the FDA may be questioning whether Gardasil would be effective in this older age group.
Reuters news story (Free)
Package Insert (prescribing information) (Free PDF)