Photo: Rafael Henrique/SOPA Images/LightRocket via Getty Images
AstraZeneca announced on Friday that the Food and Drug Administration has authorized the company to restart phase 3 clinical trials for its coronavirus vaccine, which were paused in early September.
Why it matters: All clinical trials were temporarily halted in September after a volunteer became ill with transverse myelitis upon receiving a second dose of the vaccine.
- AstraZeneca had resumed its trials in the U.K. with permission from the Medicines Health Regulatory Authority days after the participant fell ill.
Driving the news: Johnson & Johnson — the only company testing a single-shot vaccine — also plans to resume its vaccine trial, the Washington Post reports. It paused on Oct. 12 after a participant suffered from a stroke, but it was concluded to be unrelated to the vaccine shot.
What they're saying: "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," AstraZeneca CEO Pascal Soriot said. "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."
- "It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety," the company said in its Friday announcement.
What to watch: AstraZeneca said it expects results from late-stage trials to be released later this year, depending on infection rates where the trials are being held.