Vaccine manufacturing company Serum Institute of India on Tuesday said the Oxford University and AstraZeneca’s Covid-19 vaccine will not be released in India for mass use unless proven immunogenic and safe.
The company also said the serious adverse event that happened to a volunteer in Chennai, though unfortunate, was in no way induced by the vaccine.
The Institute, which had earlier said it would claim over Rs 100 crore [$13.58 million] in damages from the volunteer for damaging its reputation, said it was sympathetic with the volunteer’s medical condition and the incident was 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 statement said.
According to the Institute, the concerned authorities were informed and the principal investigator of the 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 immunization; 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 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,” NGR Prasad, advocate, Row & Reddy, told IANS.
“Our client had restricted his claim only for Rs 5 crore [$68,000] 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.”