Sanofi Pasteur MSD's Gardasil shows strong efficacy in FUTURE trials but questions remain

European vaccines specialist Sanofi Pasteur MSD says that strong efficacy data on its cervical cancer vaccine Gardasil (quadrivalent human papilloma virus [types 6, 11, 16, 18] recombinant vaccine) were published in the May 14 issue of the New England Journal of Medicine.

According to the firm, in the first study, Gardasil provided 100% protection against cervical, vaginal and vulvar diseases caused by the four HPV types Gardasil is designed to protect against while, in the second study, the vaccine provided 98% protection against advanced cervical pre-cancers caused by the two primary cancer-causing HPV types, HPV 16 and 18. These results, seen in 15- to-26-year-old women who were not infected with the relevant HPV types when they began the study, were sustained through an average of three years of participation in the trials, including an additional year of follow up since data were presented to the Food and Drug Administration for US approval.

It is estimated that, in 2007, cervical cancer will strike more than 11,000 women in the USA and nearly 500,000 around the world. Gardasil helps protect against the four HPV types - 6, 11, 16 and 18 - that cause the most disease, including 70% of cervical cancer cases and 90% of cases of genital warts. All four types cause a large number of abnormal results from Pap cervical smear tests and low-grade cervical lesions, according to the firm.