Merck: Gardasil Fast-Tracked for Older Women
Merck: Gardasil Fast-Tracked for Older Women
Merck has announced that the Food and Drug Administration has fast-tracked the cervical cancer vaccine Gardasil for review, pending approval for women ages 27 to 45. The priority review status granted to Gardasil will ensure that a FDA decision on older women will come within six months, about four months sooner than the average review period.

Gardasil, manufactured by Merck, was already approved by the Food and Drug Administration in 2006, for girls and young women, although it has been strongly criticized due to its high price. Gardasil is one of Merck's top-selling products with $1.5 billion in sales last year.

Gardasil protects against four types of HPV and it should be given in three doses over a six-month period. It does not only protect against cervical cancer development, but also against precancerous genital lesions and genital warts caused by HPV. Researchers say that condoms are not 100 percent sure against HPV infections, although they provide protection against other diseases.

About 10,000 women are diagnosed with cervical cancer, and 3,700 die each year. But health officials say that HPV infection should not be considered just a women’s problem, as women contact the virus from men. Merck is working on trials and as soon as next year the vaccine will be available for boys, too. In Australia, Mexico and countries of the European Union, the vaccine is approved for boys.

However, parents of boys are reticent about having their sons vaccinated for a problem that is supposed to be female-related. Researchers warn that two of the four HVP types for which Gardasil is approved, are found in 90 percent of genital warts that affect both men and women.



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