Serum Institute says Covishield vaccine not the cause of Chennai volunteer adverse event, followed regulatory processes

Serum Institute of India (SII) on Tuesday once again reiterated that the incident with the Chennai volunteer serious adverse event was in no way induced by the 'Covishield' vaccine and the company has followed all the requisite regulatory and ethical processes diligently, before it went ahead with the trial.

The company said 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," the company said in a statement.

The vaccine maker added 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," Serum Institute said in a statement.

The company further said 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," it said.

A 40-year old volunteer from Chennai whose name was kept confidential, has alleged serious side effects, including a neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the testing, manufacturing and distribution of the vaccine. The participant was administered the vaccine at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites, on October 1.

The participant claimed in his notice that the vaccine administered on him on October 1 was indeed Covishield, and not a placebo, as this was established from a positive test for antibodies against Covid-19 done after he was admitted to the hospital on October 11. He was admitted 11 days after receiving the vaccination.

Serum Institute called the allegations in the notice “malicious and misconceived” and has threatened to seek damages in excess of Rs 100 crore. The company said that while it is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer.

Meanwhile Serum Institute's move to seek damages from the trial participants drew flak from public health experts.

Read here on the response of clinical trial participant's lawyer and what health experts have said.