Is a U.K. teen's death a setback for GSK's cervical cancer vaccine?


Just when GlaxoSmithKline (GSK) was set for U.S. Food & Drug Administration approval of its cervical cancer vaccine, tragedy struck in the United Kingdom. Natalie Morton, a 14-year-old British girl, died Monday a few hours after receiving the vaccine, called Cervarix. On Tuesday, the FDA delayed its expected approval.

GSK spokesperson Sarah Alspach told DailyFinance in an e-mailed statement that "the event in the U.K. has not been a factor in the extended review." She noted that "the FDA did not provide a specific timeline" as to when it will reach a decision, but added that "GSK remains confident in the BLA [biologics license application] submission and expects the FDA to complete the review soon."