Vaccines Panel Recommends Cervarix, Gardasil

An FDA vaccines advisory committee has recommended that the FDA approve GlaxoSmithKline’s (GSK) BLA for human papillomavirus vaccine Cervarix to prevent cervical and other cancers in females age 10–25 and approve Merck’s Gardasil sBLA to prevent genital warts in males age 9–26. The Vaccines and Related Biological Products Advisory Committee voted 12–1 to recommend Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant) as effective in preventing diseases associated with HPV types 16 and 18 in girls and women age 10–25.
Washington Drug Letter