After a Chennai-based man claimed that he suffered neurological and psychological side effects after taking Covishield Covid-19 vaccine during the human trials, Serum Institute of India has once again asserted on Tuesday that the Covishield vaccine is safe and immunogenic and the company has followed all the requisite regulatory and ethical processes diligently, before going ahead with the vaccine trial.
"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," the company said in a statement.
A 40-year-old Chennai-based business consultant, who was a volunteer for the third phase of the vaccine trial conducted by Serum Institute of India has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to SII and others, besides seeking a halt to the trial.
The company on Tuesday said that the concerned authorities were informed and the Principal Investigator, Data and Safety Monitoring Board (DSMB) and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial. The company also said that it had submitted all the reports and data related to the incident to the Drug Controller General of India (DCGI).
"It is only after we cleared all the required processes that we continued with the trials," the company added in a statement.
Serum Institute had rejected charges that AstraZeneca-Oxford's Covid-19 vaccine candidate has serious side effects and said that the company will seek damages in excess of Rs 100 crore for "malicious" allegations on Sunday.
"The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer's medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer," Serum Institute of India had said in a statement. The volunteer is falsely laying the blame for his medical problems on the Covid-19 vaccine trial, it added.
"The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In-spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company," Serum Institute said. It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive, it added.