The U.K. girl who died after vaccination with GlaxoSmithKline's Cervarix had a "serious underlying medical condition which was likely to have caused death," said Dr. Caron Grainger, joint director of public health for that National Health Service region (as quoted by Reuters). The human papillomavirus vaccine was "most unlikely" to have been the cause, Grainger added.
Nonetheless, Glaxo (GSK) voluntarily recalled the batch of vaccine used on the girl, while it conducts its own investigation into the death. The batch will be tested as part of that investigation. Grainger said the NHS also is waiting for some test results to verify the cause of death.
Meanwhile, the U.S. FDA said it would put off deciding whether to approve Cervarix. The shot is OK'd for sale in the U.K. and almost 100 other countries, but is not yet approved in the U.S. An FDA advisory panel recently backed the vaccine for approval, however. There's no indication that FDA is missing the deadline because of the death in Britain; the agency often delays approval decisions.
In any case, the missed deadline isn't good news for Glaxo, which has already faced delays in getting U.S. approval. The longer it has to wait before getting into the U.S. market, the less chance it has to fight for market share with Merck's HPV shot Gardasil.
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