GlaxoSmithKline, the second biggest pharmaceutical company in the world, has announced that it will send new data about its Cervarix cervical cancer vaccine in the first half of 2009.

Since FDA usually takes six months to approve such a vaccine, the US release of the product is expected to have a one year delay.

GSK has said that the delay is due to the fact that the company wanted to include a new study, called HPV-008, in the data it will submit. The reason for doing this is the possibility of getting a stronger US label for the vaccine, as well as reducing the risk the company might face of being asked by the FDA for more studies, which would delay the release of Cervarix even more.

According to Reuters, Barbara Howe, from GSK’s North American vaccine development department, said that “Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix.”

Cervarix is a vaccine that can be administered to young women and is targeted against four strains of the human papilloma virus. According to medical studies, the virus accounts for about 70 percent of the cervical cancer cases and about 80 percent of the women become infected with it throughout their lives. Cervical cancer is the second most frequent type of cancer that women in the US develop, only breast cancer being more common.

Cervarix’s approval in the US is extremely important for GSK, which expects the vaccine to bring billions in revenues. The vaccine has already been approved in the European Union, Australia, Mexico, Philippines and Singapore.