GSK quarantines Cervarix batch after U.K. death

GlaxoSmithKline (GSK) has quarantined a batch of its Cervarix vaccine when a 14-year-old British girl died soon after getting the shot at school. Officials are investigating the death, stressing that the human papillomavirus vaccine may not have caused it. "No link can be made between the death and the vaccine until all the facts are known and a post mortem takes place," Dr. Caron Grainger, a National Health Service public health director, said in a statement (as quoted by Reuters).

Glaxo said it's working with U.K. health and drug officials to probe the case. The company quarantined that particular batch of vaccine "as a precautionary measure," in case it might have been contaminated. A small number of other girls at the school experienced dizziness and nausea after being vaccinated, but none required hospital care.

The girls were vaccinated as part of a nationwide immunization program with Cervarix in the U.K. More than 1.4 million doses have been administered in Britain.

The probe comes at a time when U.S. regulators are in the last stages of considering whether to approve Cervarix for use stateside. An FDA advisory panel recently recommended approval, but FDA officials have yet to issue their final decision. Meanwhile, a Japanese advisory committee recommended approval for Cervarix earlier today; the health minister is set to decide within a month.

- see the Reuters story
- get more from PharmaTimes
- check out the Japanese news from Reuters

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.