The neurological syndrome that appeared in one of the participants in the Ebovac 2 clinical trial was probably unrelated to the vaccine itself. But after the death of another patient during Rennes clinical trial last January, the world of therapeutic trials took precautions.
According to France Blue Alsace who revealed the information, this volunteer developed Miller-Fisher syndrome, a rare form of Guillain-Barré syndrome affecting the cranial nerves. Inserm therefore decided to suspend the study from April 27. It will not resume until the National Medicines Safety Agency has given its final green light.
The volunteer had already received the two injections provided for in the trial protocol: the first three months earlier and the second 26 days before. But his doctors consider the vaccine’s responsibility to be “unlikely” and “rather suspect that the problem was caused by a febrile illness which had arisen a week earlier,” said Janssen, the laboratory sponsoring the trial, at Figaro.
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