The Serum Institute accused the volunteer of falsely blaming the vaccine trial for his medical problems.
Highlights
- Oxford Covid vaccine is "safe, immunogenic", says Serum Institute
- A trial volunteer in Chennai had alleged adverse effects
- The vaccine-maker called the volunteer's allegations "malicious"
The Oxford coronavirus vaccine is "safe and immunogenic", the Serum Institute of India has asserted today, battling a massive controversy over a trial volunteer in Chennai alleging adverse effects including "virtual neurological breakdown, memory loss and behavioral changes".
In a statement, the Adar Poonawalla-led Serum Institute also defended its legal notice to sue the volunteer, saying it was sent to "safeguard the reputation of the company which is being unfairly maligned."
The vaccine-maker, calling the volunteer's allegations "malicious and misconceived", is prepping to file a ₹ 100 crore defamation suit. Some experts have expressed concern over what they see as an attempt to intimidate the trial participant.
"The COVISHIELD vaccine is 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," Serum Institute said in its statement on what it called the "serious adverse event" reported by the volunteer.
The company said the Principal Investigator of 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 want to assure everyone that the vaccine won't be released for mass use unless it is 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."
A 40-year-old Chennai man, who was a volunteer for the third phase of the Covid vaccine trial and was administered a dose on October 1, has claimed ₹ 5 crore as compensation for "a serious adverse event after being administered the under-trial vaccine".
According to his legal notice on November 21, ten days later he began experiencing "severe headaches", "total behavioural change" and "irritation towards light and sound". Subsequently, the notice claims, he could not recognise or speak to anyone.
On October 26 he was discharged from hospital after suffering from "Acute Encephalopathy" that, the notice claims, was "an extreme side effect of the test vaccine..."
The Serum Institute accused the volunteer of falsely blaming the vaccine trial for his medical problems.
The SII has partnered with pharmaceutical giant AstraZeneca to develop the Oxford vaccine candidate to fight Covid.