Covishield Safe And Immunogenic, Serum Rejects Volunteer's Claims of Suffering Side Effects
The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned, ANI quoted SII as saying.
Vaccine manufacturing major, the Serum Institute of India (SII) said on Tuesday that its vaccine candidate for the coronavirus disease (Covid-19) is "safe and immunogenic". The company further added that the incident with one of the volunteers during clinical trials was "no way induced by the vaccine."
"All regulatory, ethical processes and guidelines were followed by the company. The principal investigator DSMB (Data and Safety Monitoring Board) and ethics committee stated it was non-related issue to vaccine trial," news agency ANI reported, quoting a statement from the SII.
"The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned," ANI quoted SII as saying.
Earlier also Serum had dismissed claims that a volunteer for the Covid-19 vaccine candidate being developed in its facilities had serious side effects. "Serum Institute of India is sympathetic with volunteer's medical condition, there's absolutely no correlation with vaccine trial and his medical condition. He's falsely laying blame for his medical problems on trial," the vaccine developer said in a statement earlier.
According to a PTI report, a 40-year-old man who took part in the 'Covishield' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial.
"The claim is malicious because volunteer was specifically informed by medical team that complications he suffered were independent of vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign reputation of company," the world's largest vaccine producer said in a statement earlier.
A senior ICMR official has also said that a preliminary assessment has not indicated any causal link between the alleged adverse events shown by the volunteer and the 'Covishield' vaccine.
The man was administered the shot at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.
A law firm on his behalf has now sent a legal notice to Director General of ICMR, CEO, Serum Institute of India Private Limited, Pune, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator of Oxford Vaccine Trial and Vice Chancellor of Sri Ramachandra Higher Education and Research.
The SII has partnered with British-Swedish biopharmaceutical giant AstraZeneca AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.
Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, said the causal link, if any, of the serious adverse events with the investigational product is objectively assessed in any clinical trial following a pre-defined scientific pathway and within a stipulated period.
"Any hurried inquiry or inference is prone to be wrong. Both the institutional ethics committee and the DCGI are investigating the causal links, if any, between the adverse events and investigational product, which is an anti-coronavirus vaccine. A preliminary assessment has not indicated any causal link as yet," Dr Panda said.
Published:Tue, December 01, 2020 2:17pm