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FDA approves first cervical cancer-preventing vaccine

The vaccine may reduce the chance of developing cervical cancer by 70%.

Issue: July 1, 2006

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The FDA has approved Merck’s vaccine against human papillomavirus (HPV) to prevent cervical cancer, precancerous genital lesions and genital warts caused by HPV types 6, 11, 16 and 18.

“Clearly, this could make a large impact on women’s health,” John T. Schiller, MD, of the NCI, said. “It can reduce a woman’s chance of getting cervical cancer by 70%.”

“Today’s FDA approval of the HPV vaccine Gardasil is a major advance for cancer prevention and for women everywhere,” said ASCO president Gabriel N. Hortobagyi, MD, in a prepared statement. “The HPV vaccine has the potential to dramatically reduce the toll of cervical cancer in the U.S. and worldwide, and even opens up the possibility of eliminating a cancer in our lifetime.”

The FDA approved the vaccine for use in females aged 9 to 26 years.

About the vaccine

Merck’s recombinant vaccine is given as three injections over six months. Although the vaccine is expected to prevent most cases of cervical cancer due to the HPV types it contains, women and girls who were previously infected with HPV will not be protected.

The FDA based its approval on four studies of more than 21,000 women aged 16 to 26. Results showed the vaccine was nearly 100% effective in preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions and genital warts caused by the HPV types contained in the vaccine.

Researchers also performed two studies to measure the immune response to the vaccine among girls aged 9 to 15 years. Their immune response was comparable to the response among women aged 16 to 26. Researchers evaluated safety in a study of about 11,000 participants.

Merck agreed to further study the vaccine post-licensure, including general safety and long-term effectiveness. Merck will continue studies to evaluate the vaccine in men and to study the pregnancy outcomes of women who receive Gardasil while unknowingly pregnant.

There is a second HPV vaccine in the pipeline. GlaxoSmithKline expects to file for FDA approval of its candidate HPV types 16 and 18 L1 virus-like particle vaccine with adjuvant AS04 against HPV (Cervarix) before the year’s end. The company already filed for approval of the vaccine in Europe in March.

The GlaxoSmithKline vaccine is under evaluation in phase-3 clinical trials that involve more than 30,000 women worldwide. Results from studies so far demonstrate it has 100% efficacy against precancerous lesions associated with HPV types 16 and 18 over a 4½-year period. – by Judith Rusk