Center clears Oxford vaccine trials in India after volunteer's allegations of adverse effects.

The government of India dismissed allegations against Serum Institute of India’s vaccine candidate and said there is no need to dismiss trials.

Serum Institute of India (SSI) has collaborated with Oxford University and pharmaceutical giant Astra Zeneca for developing a COVID-19 vaccine, 'Covishield,' for which it is conducting trials in India.

A 40-year-old man who took part in the 'Covishield' vaccine trial in Chennai alleged severe side effects, including a virtual neurological breakdown and cognitive functions impairment. According to the volunteer's wife, her husband found difficulty doing simple tasks like online payments that he used to do previously. A law firm representing the volunteer's family sent a legal notice to SII seeking Rs 5 crore compensation. They urged to immediately stop testing, manufacturing, and distribution of the 'Covishield' vaccine.

Apart from the SII, the law firm has sent the legal notice to the Director-General of Indian Council of Medical Research, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO (AstraZeneca), Professor Andrew Pollard (Chief Investigator, Oxford Vaccine Trial), and Vice-Chancellor, Sri Ramachandra Higher Education and Research center. The patient alleged that DCGI, ICMR, and SII didn't connect with him for a follow-up even after a month of severe adverse reaction to the vaccine trial.

On December 1, 2020, Health Secretary Rajesh Bhushan, in a press briefing, said that they had found no reason to stop the Oxford vaccine trials in India after reviewing the Chennai volunteer's allegation of serious adverse effects, including memory loss and behavior change.

The Adar Poonawalla-led Serum Institute of India (SII), through a social media post, stated that the vaccine was safe and immunogenic. It had independently cleared the trials after examining the complaint by the Data and Safety Monitoring Board and the Ethics Committee. The institute has sent a legal notice to the Chennai volunteer for defaming the reputation of the company.

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