Two coronavirus vaccine trials that had been paused in the US are back up and running after investigations found that the illnesses that occurred were not due to the vaccines, the New York Times reports. Last week, Moncef Slaoui, the head of the US Operation Warp Speed, told Bloomberg that he expected the trials to resume shortly.
AstraZeneca paused its late-stage SARS-CoV-2 vaccine trial in September after two trial volunteers experienced an adverse neurological reaction. The company soon resumed its trial in the UK and other locations around the world, but it remained paused in the US. Earlier this month, Johnson & Johnson paused its late-stage SARS-CoV-2 vaccine trial after a volunteer became ill.
According to the Wall Street Journal, regulators at the US Food and Drug Administration did not find the experimental AstraZeneca vaccine was linked to the reactions among the volunteers, though the officials could not fully rule it out. It adds that the FDA is requiring the researchers to inform study participants about the cases and to monitor for any neurological symptoms
Meanwhile, FDA officials also found no evidence that the stroke that a man in the J&J study had was unconnected to the vaccine under study, the Washington Post reports. The Times notes that J&J say many factors could have caused his illness.
"The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic," Pascal Soriot, the CEO of AstraZeneca, tells the Financial Times.