
Madras High Court Issues Notice To SII, DCGI, ICMR On Plea By Volunteer Alleging Side Effects After 'Covishield' Trial
Live LawThe Madras High Court on Friday issued notice on a plea filed by a participant of the clinal trial of Oxford/Astra Zeneca vaccine 'Covishield' produced by the Serum Institute of India who allegedly suffered serious side effects after receiving the first dose in the trial. The petitioner, one Asif Riaz, alleges that he suffered from a severe side effect and was consequently hospitalized from 11thOctober 2020 to 26thOctober 2020; that this effect could be categorized as a "Serious Adverse Event " under Rule 2 read with sub-rule of Rule 41 of the New Drugs and Clinical Trial Rules, 2019. It has also been stated that the Participant Information Sheet provided to the Petitioner revealed that the vaccine was safe and, if there was any side effect, it would be very mild. Post being discharged from the hospital on 26th October, the Petitioner was provided a discharge summary stating that he had suffered from "Acute Neuro Encephalopathy", which came under the definition of an SAE.
History of this topic

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