IBS says his Covishield vaccine candidate is safe and immunogenic, incident with the volunteer in no way induced by him
The Serum Institute of India (SII) said on Tuesday that its vaccine candidate for coronavirus disease (Covid-19) is “safe and immunogenic.”
The company also said the incident with one of the volunteers during clinical trials was “in no way induced by the vaccine.”
“The company followed all regulatory and ethical guidelines and processes. The principal investigator DSMB (Data and Safety Monitoring Board) and the ethics committee affirmed that it was not an issue related to the vaccine trial, ”reported the ANI news agency, citing a statement from the SII.
The Pune-based company also said it sent a legal notice to a man who claimed he had developed serious side effects in human trials. “The legal notice was sent to safeguard the reputation of the company that is being unfairly defamed,” ANI said, citing the SII.
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The man had delivered a legal notice to the SII, claiming to have suffered a virtual neurological collapse and impaired cognitive functions, seeking compensation of 5 million rupees and the suspension of the trial.
IBS has collaborated with the University of Oxford and AstraZeneca Plc to test Covishield, the candidate vaccine they developed.
Along with IBS, the man also named the Indian Council of Medical Research, one of the sponsors, and the Chennai-based Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man.
Also Read: IBS Will Sue Man Over Covishield Side Effects Claims
The man, according to the notice, suffered from acute encephalopathy, a disease that affects the brain, after vaccination and all tests confirmed that the setback in his health was due to the candidate vaccine.
The Comptroller General of Drugs of India (DCGI) had deployed an institutional ethics committee at the deployment site to investigate the adverse event.