The company said the US Food and Drug Administration authorized the restart Thursday after reviewing all of the global safety data and concluding it was safe to resume. The trial had already resumed in other countries.
Government health officials, as well as outside experts, have said the hold is an example of how the safety process is working and protecting Americans from any potentially dangerous vaccines. Regulators wanted to check to make sure any problems could not have been caused by the vaccine. An internal AstraZeneca safety report obtained by CNN last month showed the study volunteer, a previously healthy 37-year-old woman, “experienced confirmed transverse myelitis” after receiving her second dose of the vaccine, and was hospitalized on Sept. 5. The woman was enrolled in the UK arm of the trial, which is run by the University of Oxford.
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