Feds Approve New HPV Vaccine

By: CNN
By: CNN

WASHINGTON (CNN) -- The Food and Drug Administration approved on Friday a second vaccine intended to protect against cervical cancer.

Cervarix, manufactured by GlaxoSmithKline, was approved for prevention of cervical cancer and pre-cancerous legions caused by human papillomavirus (HPV) types 16 and 18.

The vaccine is approved for use in girls and women ages 10 to 25 years and is to be administered in three doses. After the initial shot, the second and third doses are to be given within six months.

"The licensure of Cervarix adds another option in the prevention of cervical cancer" said Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research. "It has the potential to save lives from cervical cancer as well as reduce the need for biopsies and invasive procedures associated with the necessary follow-up from abnormal Pap tests."

According to GlaxoSmithKline, the vaccine is 70 percent effective against pre-cancerous lesions, regardless of HPV type.

"The vaccine contains two HPV types (16 & 18) responsible for the majority of cervical cancers in North America," said Sarah Alspach, GlaxoSmithKline spokeswoman. "But approximately 25 percent of cervical cancers are caused by other cancer-causing HPV types. Cervarix has been shown to reduce the incidence of pre-cancers resulting from cancer-causing virus types beyond 16 and 18."

The vaccine will be available this year, according to GSK, which did not divulge the price.

Cervarix will be competing with Merck & Company's Gardasil, the first cervical cancer vaccine, which won FDA approval in June, 2006. Gardasil, for girls and women ages 9 to 26, prevents against cervical, vulvar and vaginal cancers and protects against HPV types 11, 16 and 18.

Gardasil's approval has been broadened by the FDA to include an indication for boys and young men ages 9 through 26 for prevention of genital warts caused by HPV types 6 and 11.

"This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts." Midthun said.

According to the Centers For Disease Control and Prevention, HPV is the most common sexually transmitted infection in the nation.

More than 40 types of HPV can infect genital areas, according to the disease agency. But because many of them are not visible to the naked eye, most people who become infected don't know it.

The-CNN-Wire/Atlanta
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