Gardasil, Cervarix face FDA next month

Fierce Pharma

Gardasil will have another chance at broader use next month. The FDA’s vaccines advisory committee will meet to consider data on use of the human papillomavirus vaccine in boys and young men. In males, HPV can cause genital warts, penile cancer and other rare cancers. And then there’s the herd immunity argument: By vaccinating boys and young men, we’d help prevent their passing the virus to girls and women, thereby bringing down overall incidence.

Whether the FDA’s expert advisors will think that these benefits outweigh the potential risks of expanding Gardasil use is up for grabs. They weren’t thrilled about the idea of expanding Gardasil use to older women–ages 27 to 45–when it came up in January. The committee asked for more data, which is expected in the fourth quarter.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.