FDA: More data needed before Gardasil is approved for older women

Six months after the FDA rejected Merck and Co.’s request to approve the distribution of Gardasil – the HPV vaccine – to women aged 27 to 45, they’ve sent a response letter to Merck requesting that they resubmit their request after a full 48-month study. Merck’s original application included research from a 24-month period.
As Shark Fu noted, January is Cervical Cancer Awareness Month, so I’m not too surprised that this update is being released now. The good news is that the end of the 48-month study will be by the fourth quarter of 2009. Let’s just hope this will be enough.
In the meantime, Merck also requested FDA approval for its use in males last month. I’m definitely curious how that’s going to play out.