FDA Approves New Vaccine for Prevention of Cervical Cancer

The FDA approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18. The vaccine was approved Oct. 16, for use in girls and women ages 10 years through 25 years.

Genital HPV infections are the most common sexually transmitted diseases in the United States, and HPV types 16 and 18 are the cause of about 70 percent of cervical cancers worldwide. There will be an estimated 11,270 new cases and 4,070 deaths from cervical cancer in the United States during 2009, according to the National Cancer Institute at the National Institutes of Health.

“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,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

The primary clinical study for Cervarix included more than 18,000 women ages 15 years through 25 years in the United States and 11 other countries. Of these women, about 9,000 received Cervarix and 9,000 received Havrix, a licensed hepatitis A virus vaccine, as a control.

The current data show that Cervarix provides protection for about 6.4 years, but additional information on the length of protection is forthcoming.

Cervarix is manufactured by GlaxoSmithKline Biologicals.

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