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New studies by Merck seek boost for Gardasil

By Linda A. Johnson
Associated Press / February 18, 2010

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TRENTON, N.J. - The Gardasil vaccine appears to protect most young women from cervical cancer and homosexual men from anal cancer for at least a few years, according to new studies released yesterday by its maker, Merck & Co.

The vaccine is designed to block four of the most common strains of the sexually transmitted human papilloma virus, or HPV. Two of those HPV strains cause the majority of cases of cervical cancer and anal cancer, and the other two can cause genital warts.

Gardasil, Merck’s top-selling vaccine, already is approved for prevention of cervical cancer and genital warts in girls and women aged 9 to 26. It’s also approved for preventing genital warts in boys and men aged 9 to 26.

Data from the new studies will be used to seek approval from the Food and Drug Administration to also market Gardasil for preventing cervical cancer and genital warts in women up to age 45 and for preventing anal cancer in males.

Merck, which is based in Whitehouse Station, N.J., funded both studies.

The women’s study found three injections of the vaccine over six months reduced risk of developing precancerous lesions on the cervix, as well as genital warts and persistent infections of HPV, in about 89 percent of the participants, compared with women in a group that got three dummy shots.

The second study found three injections of the vaccine reduced risk of young men developing anal cancer or precancerous lesions of the anus by about 77 percent, compared with those in a group getting dummy shots.