Drugmaker AstraZeneca will resume the trial of its experimental coronavirus vaccine in the United States, which has been on hold since September.
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.
The trial was paused after a volunteer in Britain developed a neurological condition suffered by one of the participants in its coronavirus vaccine clinical trials around the world.
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.
The company has been working with Britain’s University of Oxford to develop the vaccine, one of four that started late-stage, Phase 3 trials in the US.
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.
The document, labeled an “initial report,” described how the study participant had trouble walking, weakness and pain in her arms, and other symptoms.
The company said in the release Thursday that results from late-stage trials are expected later this year, depending on infection rates where the trials are being conducted.