AstraZeneca’s COVID-19 vaccine trial is pending in the United States in the United States, a US investigation of a serious side effect, sources told sources familiar with Reuters details, as sources said. Told.
AstraZeneca said on Saturday that it had resumed its testing in the UK as regulators completed a review of serious side effects in a test participant there.
This was the first indication that US testing would be halted until the US Food and Drug Administration and safety panel investigated the case.
The company’s enrollment in global trials of the vaccine, which it is developing with researchers at the University of Oxford, was called off on 6 September.
Sources told Reuters that rescheduling was being done at least until midweek for enrollment of new patients and other testing procedures, and it was unclear how long it would take the FDA to complete its investigation.
Governments around the world are desperate for a vaccine to help end the epidemic, which has led to more than 900,000 deaths and global economic turmoil. AstraZeneca was marked by the World Health Organization (WHO) as the most promising. A prolonged delay in US testing may slow down access to the vaccine in the United States.
In a British adverse event, a study the patient felt was a rare spinal inflammatory disorder called transverse myelitis.
A spokesman for AstraZeneca declined to comment on when the US trial would begin. She said in an email that the company “will continue to work with health authorities around the world, including the FDA and may resume other clinical trials.”
The status of South African and Indian trials is unknown, but testing has also resumed in Brazil. The company has not commented on the timing of the restoration in other parts of the world other than the UK.
The FDA did not immediately respond to a request for comment.
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