Brazilian pediatrician Monica Levi, one of the volunteers who received the COVID-19 vaccine, works at the Clinic for Infectious and Parasitic Diseases and Immunizations (CEDIPI), in Sao Paulo, Brazil, on July 24, 2020. The doctor in is one of 5,000 volunteers participating in Brazil in phase 3 trials – the last before approval – of the ChAdOx1 nCoV-19 vaccine, developed by the University of Oxford in collaboration with the British pharmaceutical company AstraZeneca.
Nelson Almeida | AFP | Getty Images
AstraZeneca’s Covid-19 vaccine trial remains on hold in the United States pending a US investigation into a serious side effect in Britain even as other vaccine trials resume, told Reuters sources close to the details.
AstraZeneca said on Saturday it had relaunched its trial in Britain after regulators completed their review of a serious side effect in a trial participant there.
It was the first indication that the US trial will remain on hold until the US Food and Drug Administration and a safety group investigate the case.
Registration for the company’s global vaccine trials, which it is developing with researchers at the University of Oxford, was suspended on September 6, Reuters told Reuters that the recruitment of new patients and other procedures will The trial for the US pivotal trial was postponed until at least midweek and it was not clear how long it would take the FDA to complete its probe.
Governments around the world are in desperate need of a vaccine to help end the pandemic, which has caused more than 900,000 deaths and a global economic crisis. The World Health Organization had called the AstraZeneca the most promising. A prolonged delay in the US trial could slow access to the vaccine in the United States.
The UK side event involved a patient in the study who reportedly suffered from a rare spinal inflammatory disorder called transverse myelitis.
A spokeswoman for AstraZeneca declined to comment on the resumption of the US trial. She said in an email that the company “will continue to work with health authorities around the world, including the FDA, and will be guided as to when other clinical trials can resume.”
The status of the South African and Indian trials remains unknown, but the trial in Brazil has also restarted. The company has not commented on the timing of the recovery in other parts of the world outside of Britain.
The FDA did not immediately respond to a request for comment.
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