AstraZeneca waiting for FDA to greenlight restart of US drug trial
It's been nearly 3 weeks since the trial was halted over safety concerns
AstraZeneca says it's still waiting on federal approval to resume the U.S. clinical trial of its COVID-19 vaccine candidate nearly three weeks after the study was halted over safety concerns.
During a virtual World Economic Forum discussion Thursday, AstraZeneca CEO Pascal Soriot noted that the company has sent information to the Food and Drug Administration (FDA) and is still "waiting to hear their decision,” according to Reuters.
OXFORD, ASTRAZENECA RESUME CORONAVIRUS VACCINE TRIAL
The vaccine had been widely perceived to be one of the most advanced contenders among the dozens of coronavirus vaccines in various stages of testing around the world.
However, earlier this month, the company disclosed that the late-stage studies of its vaccine candidate, which is being developed in partnership with Oxford, was put on hold in order to investigate whether a U.K recipient’s “potentially unexplained” illness was a side effect of the vaccine.
Aside from an internal investigation, Food and Drug Administration Commissioner Stephen Hahn said the agency would also be conducting its own investigation into the matter in order to see if the illness was linked to the trial.
“We’re here to protect the American public and we’re going to do very significant work with the company to figure out if there’s a significant safety issue or not,” Hahn told South Carolina Republican Sen. Tim Scott in an interview earlier this month.
ASTRAZENECA COVID-19 TRIAL ON HOLD IN US AS FDA INVESTIGATES UK PARTICIPANT'S SERIOUS ILLNESS
In August, AstraZeneca began recruiting 30,000 people in the U.S. for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.
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During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety.
The trials also assess effectiveness by tracking who gets sick and who doesn’t between patients getting the vaccine and those receiving a dummy shot.
FOX Business' Lucas Manfredi and The Associated Press contributed to this report.