AstraZeneca Plc’s AZN.L COVID-19 vaccine trial in the United States is expected to resume as early as this week after the U.S. Food and Drug Administration completed its review of a serious illness, four sources told Reuters.
AstraZeneca’s large, late-stage U.S. trial has been on hold since Sept. 6, after a participant in the company’s UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.
The sources, who were briefed on the matter but asked to remain anonymous, said they have been told the trial could resume later this week. It was unclear how the FDA would characterize the illness, they said.
An FDA spokeswoman declined to comment.
The agency is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.
UK regulatory officials previously reviewed the illness and determined there was “insufficient evidence to say for certain” that it was or was not related to the vaccine. It permitted the trial to resume enrolling participants in the UK, according to a draft of the updated consent form shared with Reuters.
https://www.reuters.com/article/us-health-coronavirus-astrazeneca-usa-ex/exclusive-astrazeneca-u-s-covid-19-vaccine-trial-may-resume-as-soon-as-this-week-sources-idUSKBN2752C5HELP US SPREAD GOOD NEWS!
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