AstraZeneca’s COVID-19 vaccine trial in the US continues to be on hold pending a US investigation of a serious side effect in the UK, even if other studies with the vaccine resume.
AstraZeneca announced on Saturday that the study resumed in the UK after regulators completed a review of a serious side effect in a study participant there.
This was the first indication that the US study would remain on hold until the US Food and Drug Administration and a security panel investigate the case.
Participation in the company’s global studies of the vaccine, which it is developing with researchers from Oxford University, was suspended on September 6th.
Sources told Reuters that new patient enrollments and other trial procedures for the central US trial would be postponed until at least midweek and it was not clear how long it would be for the FDA to complete its investigation.
Governments around the world are desperate for a vaccine to end the pandemic that has caused more than 900,000 deaths and global economic turmoil. The World Health Organization (WHO) had identified AstraZeneca as the most promising. A longer delay in the US study could slow access to the vaccine in the US.
The UK adverse event involved a study patient believed to have a rare inflammatory spinal disease called transverse myelitis.
An AstraZeneca spokeswoman declined to comment on when the U.S. trial would resume. In an email, she said the company will “continue to work with health authorities around the world, including the FDA, to seek advice on when to resume other clinical trials.”
The status of the South African and Indian trials is still unknown, but the trial in Brazil has also resumed. The company has not commented in any part of the world other than the UK at the time of resumption.
The FDA did not immediately respond to a request for comment.
(Except for the headline, this story was not edited by GossipMantri staff and published from a syndicated feed.)