Coronavirus: amid vaccine volunteer’s allegations, Serum Institute of India stresses safety of ‘Covishield’

Top shot: A scientist at work at the Serum Institute of India, Pune, which is readying doses of the Oxford vaccine. Reuters  

Amid allegations by a ‘Covishield’ vaccine volunteer who sued the Pune-based Serum Institute of India (SII) and the Oxford Group over ‘adverse reaction’ during the vaccine trial, the SII on Tuesday reiterated that the ‘Covishield’ vaccine was “safe” and “immunogenic”.

“The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition. However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly,” said the SII in another statement issued on Tuesday.

The vaccine-maker further said that the authorities concerned were informed and principal investigator the Data and Safety Monitoring Board (DSMB) and the Ethics Committee had independently cleared and reckoned the case as “a non-related issue” in the vaccine trials.

The SII clarified that following the incident, they had submitted all reports and data related to the incident to the Drugs Controller General of India (DGCI).

Also read | DCGI and institutional ethics committee investigating claim of adverse event in COVID-19 vaccine trial: officials

“It is only after we cleared all the required processes that we continued with the trials,” said the SII.

It further said that it wanted to assure everyone that the vaccine would not be released for mass use unless it was proven immunogenic and safe.

“Taking into consideration the complexities and existing misnomers about vaccination and immunisation, the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned,” it said.

₹5 crore compensation sought

Earlier last week, the SII had refuted the allegations of the 40-year-old vaccine volunteer who had alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions, and had sought monetary compensation to the tune of ₹5 crore in a legal notice to the SII, AstraZeneca and the Oxford Vaccine Group besides seeking a halt to the trial.

The SII, calling the allegations as “malicious” and “misconceived”, had further said that it would seek damages in excess of ₹100 crore for the same and would defend itself against such claims.

“The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial,” the SII had said.

Underscoring the efficacy of ‘Covishield’ trials globally, SII’ Chief Executive Officer Adar Poonawalla said last week that “zero hospitalisations” had been reported during the trials.

“The trials have established Covishield’s efficacy as it has shown to reduce the virus in a person’s system by 60% . Furthermore, zero hospitalisations were reported during the trials. What we found in these trials globally is that even if a person does get infected, it will not be a severe attack as the sterilising immunity was 60%,” he had said following Prime Minister Narendra Modi’s visit to the SII facility in Pune last Saturday.

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Printable version | Jan 28, 2021 8:19:42 AM |

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