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Francis Collins, director of the National Institutes of Health (NIH), told the Senate Committee on the 9thAstraZeneca testified that the suspension of clinical trials of the new coronavirus vaccine was due to “spinal problems.”
AstraZeneca and Oxford University, which are leading the way in vaccine development, suspended the study to verify safety data due to illness in one of the study participants.
British Astra Zeneca, Suspension of Corona-Disease of Unknown Cause Vaccine Trial
Collins noted on the Senate Committee on Education Welfare and Workforce Pensions that the adverse event in question was transverse myelitis (TM), a neuropathy that causes inflammation of the spinal cord. He also said that if AstraZeneca’s validation reveals that this adverse event is associated with a vaccine, all vaccines already manufactured will be discarded.
Principal Collins testifies at the Senate Welfare Education Occupational Pension Committee (September 9)
Photographer: Michael Reynolds / EPA / Bloomberg
Collins said: “Everyone should be relieved to hear that we focus on safety first and not commitment,” he said. “This is based on an adverse event. I don’t know if it has anything to do with the vaccine, but it’s best to take a cautious approach to discontinue and immediately confirm any evidence of concern.”
AstraZeneca CEO Pascal Sorio told investors on the morning of the 9th that the company’s vaccine trials were suspended worldwide when a British woman began developing a neurological disorder called TM. He explained that it was done.
According to AstraZeneca spokeswoman Michelle Macel, CEO Sorio said the case had not been finalized and would not be confirmed until further testing was done. “These tests will now be sent to an independent safety committee to verify adverse events and make a final diagnosis,” Macel said in a statement.
Women are on the mend, according to a report from STAT, which specializes in medical news. Although this is the second time a central nervous system problem has occurred, the first neuropathy symptom was thought to be due to multiple sclerosis and was not associated with the vaccine, STAT said.
Registry of clinical trialsAccording to subject information published in ISRCTN on July 12, one participant showed symptoms of TM in the English AstraZeneca study. The cause was said to be under investigation.
“In July, the study was suspended pending safety verification because one subject was confirmed to have undiagnosed multiple sclerosis,” Macel said. The supervisory committee explained that it concluded that the diagnosis was not related to the vaccine.
AstraZeneca may resume clinical trials next week, the Financial Times reports, citing people familiar with the matter.
Original title:
AstraZeneca study stopped after spinal cord problem, NIH chief says 、AstraZeneca must explain spinal disease to resume vaccine trial （抜 粋）
(I will update by adding explanation on Astra Zeneca side after 6th paragraph)
