FILE
Biopharmaceutical giant AstraZeneca, developing a coronavirus vaccine with the University of Oxford, has got clearance by U.S. regulators to restart a halted trial after concerns about a volunteer falling ill. According to AstraZeneca and Oxford, the FDA reviewed data from global studies and decided it was safe to begin testing again.
Among the front-runners in the global quest for a vaccine, Astra's U.S. trial will test the shot on 30,000 volunteers, taking the total number of participants in advanced trials for the jab to 50,000.
"We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use," Pascal Soriot, the drugmaker's chief executive officer, said in a statement. This "allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic.
AstraZeneca said that the results from the late-stage trials are expected later this year, and will depend on local rates of infection where the studies are taking place.
The British pharmaceutical company made headlines this week for yet another reason. A participant involved in the Brazil trial was reported dead, however, it was later determined that the volunteer was in the control arm of the study and hadn’t received the shot. Brazil’s health authority said an international committee had reviewed the event and the trial would continue.
