After a Chennai man claimed he suffered from neurological and psychological side effects after taking Covishield COVID-19
During human trials, the Serum Institute of India reaffirmed Tuesday that the Covishield vaccine is safe and immunogenic and that the company has followed all necessary regulatory and ethical processes diligently, before proceeding with the vaccine trial. .
“The incident with the Chennai volunteer, although very unfortunate, was in no way induced by the vaccine and the Serum Institute of India is sympathetic to the volunteer’s medical condition,” the company said in a statement.
A 40-year-old business consultant from Chennai, who volunteered for the third phase of the vaccine trial conducted by the Serum Institute of India, has alleged serious side effects, including virtual neurological collapse and impaired cognitive functions, and has sought R Compensation of 5 crore in a legal notice to the SII and others, in addition to seeking the suspension of the trial.
The company said on Tuesday that the concerned authorities were informed and that the Principal Investigator, the Data and Security Monitoring Board (DSMB) and the Ethics Committee clarified it independently and considered it an issue not related to the trial of the vaccine. The company also said that it had submitted all reports and data related to the incident to the Comptroller General of Drugs of India (DCGI).
“Only after approving all the required processes do we continue testing,” the company added in a statement.
Serum Institute had rejected allegations that AstraZeneca-Oxford COVID-19 The vaccine candidate has serious side effects and said the company will seek damages of more than 100 million rupees from “malicious” allegations on Sunday.
“The allegations in the ad are malicious and ill-conceived. While the Serum Institute of India is sympathetic to the medical condition of the volunteer, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer,” said Serum Institute of India in a statement. The volunteer falsely blames his medical problems on the COVID-19 vaccine trial, he added.
“The claim is malicious because the medical team specifically informed the volunteer that the complications he was suffering were independent of the vaccine trial he underwent. Despite being specifically informed of the same, he chose to go public and defame the reputation of the company, “said Serum Institute. It is clear that the intention behind the dissemination of such malicious information is an indirect pecuniary motive, he added.
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