U.S. OKs Glaxo's Cervical Cancer Shot
October 19, 2009
GlaxoSmithKline announced Friday that the Food and Drug Administration has approved its Cervarix vaccine for U.S. females ages 10 to 25.
Cervarix contains a novel additive designed to boost the immune response. A Glaxo study showed Cervarix produced more antibodies than Gardasil, but the researchers did not study whether these higher levels provided more protection against cancer. Glaxo had sought FDA's approval of Cervarix since 2007, but the agency delayed its decision while it requested more data.
Gardasil costs roughly $360 for a three-shot series, while Glaxo has not yet announced a price for Cervarix. Some critics question whether it is cost-effective to vaccinate for cervical cancer in the United States, since the disease is often caught early through Pap smears and is largely treatable in its early stages. Still, around 4,000 U.S. women die of the disease annually. Concerns about immunizing boys for genital warts have also been raised, since the warts often clear on their own without treatment.
Cervarix will debut on the market later this year, said Glaxo. The vaccine got another boost on Friday when Japan -- the world's second-largest pharmaceutical market, after the United States -- approved it, making Cervarix the first cervical cancer vaccine available there.
10.16.2009; Lisa Richwine
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.