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October 26, 2020

Health Law Daily

AstraZeneca, J&J Resume US Vaccine Trials

  • October 26, 2020

The Wall Street Journal (10/23, Burton, Subscription Publication) reports AstraZeneca and Johnson & Johnson on Friday separately announced they resumed their late-stage coronavirus vaccine trials in the US. The AstraZeneca trial was halted after two volunteers appeared to develop neurological conditions though the Food and Drug Administration could not link the symptoms to the vaccine, a source said.
      The New York Times (10/23, Wu, Zimmer) reported that Johnson & Johnson “said that its trial, which had been on pause for 11 days, would restart after a company investigation determined that a ‘serious medical event’ in one study volunteer had ‘no clear cause.’ To maintain the integrity of the trial, the company said, it did not check whether the volunteer received the vaccine or the placebo.” The Washington Post (10/24, Johnson) reports Johnson & Johnson paused its trial “due to an unexplained illness in a participant,” but an independent committee has “concluded [their stroke] was not related to the vaccine, according to two individuals familiar with the trial who spoke on the condition of anonymity.”