Lawsuit has been confirmed & statements by lead researcher at the hospital trial site to more than one journalist confirm person was in the trial, there was a serious adverse event, & they judged it *not* vaccine-associated. No official statement from the trial or regulator...1/2
https://twitter.com/hildabast/status/1332570619993473024
...According to the person interviewed, India's regulator was informed when it occurred. Until there's a report from the regulator side, we don't know official status or whether other regulators were notified. (Thank you to everyone tweeting me links to coverage in India.)
...PS: There have been multiple public statements prior to this development from the institution running the trial that there had been no serious adverse events. Hopefully the regulator will sort this out & report publicly soon.
...Reported confirmation from official source of that serious adverse event on Indian trial of Oxford/AstraZeneca vaccine, deemed not vaccine-associated. Spokesperson from the Indian Council of Medical Research: thehindubusinessline.com/news/icmr-says… Open question whether FDA, MHRA &c notified
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