The chief of the National Institutes of Health confirmed Wednesday that a “spinal cord problem” caused the suspension of the phase three trial of AstraZeneca’s coronavirus vaccine.
NIH Director Francis Collins, testifying before the Senate Committee on Health, Education, Labor & Pensions, revealed that the problem that led to the pause in the trial is a rare affliction known as transverse myelitis, a neurological disorder that causes inflammation of the spinal cord. Collins said that all of the doses of the vaccine will be thrown away if it is confirmed that it is related to the adverse event.
“This ought to be reassuring to everybody listening,” Collins said. “When we say we are going to focus first on safety and make no compromises, this is Exhibit A.”
The phase three trial is aiming to enroll 50,000 participants in both the United Kingdom and the United States. The trial was halted in both countries on Tuesday.
AstraZeneca CEO Pascal Soriot said that the participant, a woman, was improving and would likely be discharged from the hospital on Wednesday. It is not yet clear that her condition is related to the vaccine.
Soriot also confirmed to STAT that the phase three trial was also briefly shut down in July when another participant developed neurological problems. However, that participant was diagnosed with multiple sclerosis, which was unrelated to the vaccine.
