FDA Delays Decision on HPV Vaccine Cervarix

September 30, 2009 — FDA for the second time has delayed its decision on British drugmaker GlaxoSmithKline's human papillomavirus vaccine, Cervarix, the Wall Street Journal reports. According to the company, FDA did not indicate that the delay was related to reports that a 14-year-old British girl died this week after receiving the vaccine. According to a statement from British health authorities, the girl had an "underlying medical condition" that likely caused her death, and it is "unlikely that the HPV vaccination was the cause of death." The statement added that officials "are awaiting further test results, which will take some time."

FDA was scheduled to announce its decision Tuesday but told GSK it would miss the deadline, according to the drugmaker (Whalen, Wall Street Journal, 9/30). FDA does not comment on pending product reviews, an agency spokesperson said (Perrone, AP/Boston Globe, 9/29).

If approved, Cervarix would compete in the U.S. with Merck's HPV vaccine Gardasil, which FDA approved in 2006. Both drugs prevent infection with two strains of HPV that cause about 70% of cervical cancers, and Gardasil also targets two strains that cause genital warts.

GSK first sought approval for Cervarix in the U.S. in 2007, Reuters reports. Earlier this month, an independent panel recommended approval of the drug. Although FDA typically follows those recommendations, it is not obligated to do so.

Both vaccines are approved for use in about 100 countries. Cervarix had worldwide sales $199 million in 2008, compared with Gardasil's $1.4 billion (Heavey, Reuters, 9/29).