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Madras HC issues notice after Covishield volunteer plea asks vaccine be declared unsafe, seeks Rs 5 crore in damages

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The Madras High Court on Friday issued notice to the Centre following a petition by a volunteer in the third phase trials of Oxford-AstraZeneca vaccine, Covishield. The 41-year-old petitioner claimed he suffered adverse effects following the administration of the vaccine and sought Rs 5 crore damages from vaccine manufacturer Serum Institute of India for the trauma to him and his family.

The volunteer has also sought that the court declare the vaccine unsafe. The next hearing has been set on March 26. The petitioner stated he had severe side-effects after taking the vaccine and had to undergo treatment at a hospital for several days. He alleged that this effect could be categorized as a “Serious Adverse Event (SAE)” under Rule 2(ff) read with sub-rule (a) of Rule 41 of the New Drugs and Clinical Trials Rules, 2019. The plea said he had suffered Acute Neuro Encephalopathy, which comes under SAE as per the discharge summary from the hospital. The petitioner has claimed he is suffering from various neurological issues even after discharge from the hospital, which has affected his work life and creativity.

The allegations had surfaced last year and were denied by SII. The institute had also threatened to sue the man for Rs 100 crore. SII, in a statement, had said the incident with Chennai volunteer was unfortunate but had nothing to do with the vaccine. It said it has sent a legal notice to the volunteer in a bid to safeguard the reputation of the company, which, it said, was being unfairly maligned.

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The Union Health Ministry says India is currently running one of the fastest vaccination drives in the world with Oxford-AstraZeneca’s Covishield and Bharat Biotech’s Covaxin following emergency use approval by Drugs controller General of India (DCGI). More than one crore people have been vaccinated so far and although very few cases of adverse effects have been reported, the vaccines are, in general, being considered to be safe.

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