FDA Approves Gardasil Cervical Cancer Vaccine

Vaccine approved for females aged 9 to 26 to block human papillomavirus types 6, 11, 16 and 18

THURSDAY, June 8 (HealthDay News) -- For the first time, the U.S. Food and Drug Administration has approved a vaccine to reduce cervical cancer by preventing infection with human papillomavirus (HPV) types 6, 11, 16 and 18. Gardasil is manufactured by Merck & Co. and is approved for use in females aged 9 to 26.

The vaccine was given expedited approval and was evaluated and approved in just six months, which is a "major advancement in public health" because of the vaccine's potential health benefits, according to the FDA. Gardasil is administered in three injections over a period of six months and side effects are generally mild, including pain and swelling at the injection site.

Because the vaccine does not prevent all types of HPV infection and is not effective in patients already infected with the viruses, routine cervical cancer screening, including Pap smears, are still necessary. Prior to approval, Gardasil was evaluated in one U.S. and three multinational trials including 21,000 women. Trials indicate that the vaccine is as effective in stimulating an immune response in females aged 9 to 15 as in those 16 to 26, and is nearly 100 percent effective at preventing precancerous lesions of the cervix, vulva and vagina, as well as genital warts caused by HPV types 6 and 11, which currently cause 90 percent of genital warts.

"Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer," said Alex Azar, Deputy Secretary of the U.S. Department of Health and Human Services, in a statement. "HHS is committed to advancing critical health measures such as the development of new and promising vaccines to protect and advance the health of all Americans."

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