U.S. FDA Approves New Vaccine For Prevention Of Cervical Cancer

Xinhua News Agency

October 19, 2009

WASHINGTON, Oct 19, 2009 (Xinhua via COMTEX) -- The U.S. Food and Drug Administration (FDA) on Monday approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women age 10 to 25.

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.

"The licensure of Cervarix adds another option in the prevention of cervical cancer," said 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."

The primary clinical study for Cervarix included more than 18,000 women ages 15 to 25 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 results showed that among women who had not already been infected by HPV types 16 and/or 18 before the start of the study, Cervarix was about 93 percent effective in preventing precancerous cervical lesions caused by these HPV types. Among all Cervarix vaccinees, which included those who tested negative for HPV 16 and/or 18, and those who tested positive at the start of the study, Cervarix was approximately 53 percent effective in preventing precancerous cervical lesions.

Studies also were performed to measure the immune response to Cervarix in girls ages 10 to 14. Their immune response was similar to that of women ages 15 to 25, indicating that the vaccine should have similar effectiveness in the 10 to 14 years old age group.

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

The FDA said no vaccine is 100 percent effective, and Cervarix does not protect against HPV infections that an individual may already have at the time of vaccination, nor does Cervarix necessarily protect against those HPV types not in the vaccine. Therefore, regular Pap tests continue to be recommended for all women who receive Cervarix.

Cervarix is manufactured by GlaxoSmithKline Biologicals, based in the United Kingdom.

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