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CHICAGO (Reuters) – AstraZeneca’s
AstraZeneca said on Saturday it had restarted its trial in Britain after regulators completed their review of a serious side effect in a trial participant there.
This was the first indication that the US trial will remain on hold until the US Food and Drug Administration and a security panel investigate the case.
Enrollment in the vaccine company’s global trials, which it is developing with researchers at the University of Oxford, was put on hold on Sept. 6.
Sources told Reuters that new patient enrollment and other trial procedures for the pivotal US trial were rescheduled until at least midweek and that 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 pandemic, which has caused more than 900,000 deaths and global economic turmoil. The World Health Organization (WHO) had singled out AstraZeneca as the most promising. A long delay in the US trial could slow down access to the vaccine in the United States.
The British adverse event involved a study patient who is believed to have suffered from a rare spinal inflammatory disorder called transverse myelitis.
A spokeswoman for AstraZeneca declined to comment when the trial would resume in the United States. She said in an email that the company “will continue to work with health authorities around the world, including the FDA, and guide itself on when other clinical trials may resume.”
The status of the South African and Indian trials remains unknown, but the trial in Brazil has also been restarted. The company has not commented on the timing of the resumption in parts of the world other than Britain.
The FDA did not immediately respond to a request for comment.
(Reporting by Julie Steenhuysen and Marisa Taylor; Editing by Peter Henderson and Cynthia Osterman)
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