Highlights:
- The participant for the Covid-19 vaccine allegedly suffered serious side-effects after taking the experimental shots
- The Serum Institute called the Oxford Vaccine safe and immunogenetic
- Adar Poonawalla-led Serum Institute denied the allegations and called it “malicious”
The Serum Institute of India has reported today, the Oxford coronavirus vaccine is safe and immunogenic” fighting a major controversy over a volunteer trial in Chennai alleging adverse effects including “virtual neurological breakdown, memory loss and behavioral changes”.
The Adar Poonawalla-led Serum Institute also defended its lawsuit against the volunteer in a statement, claiming it was sent to “safeguard the reputation of the company which is being unfairly maligned.”
The vaccine-maker is planning to file a 100-crore defamation suit, calling the volunteer’s charges “malicious and misconceived”. Some analysts have expressed concern about what they see as an effort to intimidate the volunteer of the trial.
“The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer is extremely unfortunate and was in no way caused by the vaccine and India’s Serum Institute sympathizes with the medical condition of the volunteer,” said in its statement, the Serum Institute stated what it called the “serious adverse event” reported by the volunteer.
The company told the authorities concerned that it had implemented all regulatory and ethical procedures and standards “diligently and strictly”. It said that the Data and Safety Monitoring Board and the Ethics Committee had “independently cleared and reckoned it as a non-related issue to the vaccine trial”.
“We would like to assure everyone that the vaccine will not be released for mass use unless it is proven immunogenic, and safe. Taking into consideration the complexities and existing inaccuracies about vaccination and immunisation; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned.”
Also Read: Serum Institute to File Rs 100 Crore Defamation Case after Volunteer Claims Vaccine Made Him Ill
A 40-year-old Chennai man, who was a volunteer for the third stage of the Covid vaccine study and was given a dose on October 1, demanded 5 crores as compensation for a serious side-effect after being administered the under-trial vaccine”.
Ten days later, he started having “severe headaches” “total behavioural change” and “irritation towards light and sound” according to his legal notice on November 21. Subsequently, he did not remember or speak to anybody, the notice says.
He was released from the hospital on October 26 after suffering from “Acute Encephalopathy” which according to the notice, was an extreme side effect of the test vaccine.”
The Serum Institute accused the volunteer of wrongly blaming his medical conditions on the vaccine trial.
To develop the Oxford vaccine to combat Covid, SII has collaborated with pharmaceutical giant AstraZeneca.
