BioCentury
ARTICLE | Regulation

Choosing Cervarix or Gardasil

September 14, 2009 7:00 AM UTC

An FDA panel's recommendation for approval of Cervarix means that GlaxoSmithKline plc's bivalent HPV vaccine may soon compete with Merck & Co. Inc.'s Gardasil, a quadrivalent HPV vaccine that has been available in the U.S. since 2006. With head-to-head data lacking on clinical outcomes, the decision about which vaccine to choose is likely to boil down to whether Cervarix's label suggests broader cancer protection than Gardasil, as well as economic factors and patient preference.

FDA's Vaccines and Related Biological Products Advisory Committee Advisory Committee voted 12-1 in favor of Cervarix's efficacy and 11-1 in favor of its safety in preventing genital dysplasias associated with HPV types 16 and/or 18 in women ages 15-25. The panel also voted 12-1 that GSK's immunogenicity data suggest the vaccine is effective in adolescent females ages 10-14, who are generally considered to be too young to be sexually active and thus are not included in trials (see B8)...