Vaccine development company Serum Institute, India on Tuesday said the Covidshield vaccine will not be released for mass use unless it is proven immunogenic, and safe.
The company also said the serious adverse event (SAE) that happened to a city based volunteer though unfortunate was in no way induced by the vaccine.
Serum Institute which had earlier said it would claim over Rs 100 crore damage from the volunteer for damaging its reputation said it was sympathetic with the volunteer’s medical condition and the incident is highly unfortunate.
“However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly,” the company said.
According to Serum Institute, the concerned authorities were informed and the Principal Investigator, Data Safety Monitoring Board (DSMB) and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial.
“Post which we submitted all the reports and data related to the incident to the DCGI (Drug Controller General of India). It is only after we cleared all the required processes that we continued with the trials,” the company said.
“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,” the company added.
The 40-year-old city based volunteer, who works as a business consultant had wanted to investigate the cause of him contracting severe neurological health complications he had suffered after being vaccinated with Covidshield shots under development at Serum Institute, but the company was intimidating him with a threat of over Rs 100 crore damage suit, his advocates had said.
According to the advocates, their client was vaccinated on September 29 and developed severe neurological health complications and instead of probing the cause and stopping the trials Serum Institute and others kept silent.
“We are yet to get any reply for the legal notice sent to various parties, including Serum Institute. We have seen news reports about Serum Institute threatening our client with a suit for over Rs 100 crore,” N.G.R. Prasad, Advocate, Row & Reddy, told IANS.
“Our client had restricted his claim only for Rs 5 crore and wanted investigation to start as to the cause of him suffering severe neurological problems and stop the vaccine from affecting other people,” Prasad added.
A family friend of the volunteer told IANS: “He was a healthy young male. He had no pre-existing ailments. Not even blood pressure. But 10 days after the vaccination, he had developed severe neurological complications.”