INDIANAPOLIS (WPTA21) - The pharaceutical company that partnered with the Indiana University School of Medicine on its COVID-19 vaccine trial will restart the trial after pausing it in September.
AstraZeneca says it has been cleared by the FDA to resume its studies of the effects the vaccine has on volunteer patients in the US.
It had halted the process after one individual developed neurological problems.
Government health officials, as well as outside experts, have said the hold was 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 IU School of Medicine is also taking part in the trial, with an unspecified number of participants receiving the vaccine in Indianapolis.
The move to resume the trial in the US follows clearance recently in other nations that are taking part.