As a result, the Cervarix vaccine may not become available until mid or late 2009, at the earliest. You may recall that,last December, the FDA issued a so-called ‘complete response letter’ for Glaxo's HPV vaccine, which would compete with Merck's Gardasil, but it was unclear at the time whether additional clinical trials would be required.
Today, the drugmaker says new clinical studies are not expected to be required for approval, but other data will submitted. Specifically, this would be final data from a Phase III pivotal efficacy study, which should be available later this year and submitted to the FDA in the first half of 2009, although exact timing is hard to predict. And with another six-month review period, Cervarix won't be on the market until late 2009, at the earlier. Meanwhile, Merck gets to ring the register. Here is the Glaxo statement.