Serum Institute Of India Says Vaccine Safe, Immunogenic, Incident With Volunteer No Way Induced By Vaccine

Serum Institute Of India Says Vaccine Safe, Immunogenic, Incident With Volunteer No Way Induced By Vaccine

New Delhi: The oxford coronavirus vaccine is "safe and immunogenic", arrested the Serum Institute of India, battling a massive controversy over the trail volunteer in Chennai alleging the adverse effect including  "virtual neurological breakdown".

The Adar Poonawalla-led Serum Institute in a statement also said that the incident with the Chennai volunteer "though highly unfortunate was in no way induced by the vaccine".

The vaccine-maker has called the volunteer's allegations "malicious and misconceived" and has said it will file a ₹ 100 crore defamation suit.

"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 that it had followed all the regulatory and the ethical processes and guidelines diligently and strictly", informed the authorities concerned. 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", it claimed.

"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 immunization; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned."

The 40-year-old Chennai man, who was the volunteer for the third phase of the coronavirus vaccine trial and was administered a dose on October 1, has claimed 5 crores as compensation for "a serious adverse event after being administered the under-trial vaccine".

On November 21 according to his legal notice, ten days later he began experiencing "severe headaches", "total behavioral change" and "irritation towards light and sound". 

He on October 26 was discharged from the hospital after suffering from  "Acute Encephalopathy" that, the notice claims, was "an extreme side effect of the test vaccine..."

The Serum Institue has accused the volunteer of falsely blaming the vaccine trails for his medical problems

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