Covishield: SII refutes adverse reaction claim, seeks Rs 100-cr in damages

Vaccine major Serum Institute of India (SII) on Sunday strongly refuted an allegation that Covishield, the vaccine candidate for Covid-19, which is in the third phase of human trials in India, triggered adverse reaction in a Chennai-based 40-year-old volunteer, and said it would seek “damages in excess of Rs 100 crore” for the “malicious and misconceived” claims.

The Covid-19 vaccine, being developed by Oxford-AstraZeneca, is widely believed to be the best bet for India among at least four others in the later stages of human trials, for its relatively low price (Rs 1,000 for two requisite doses) and tested stability when stored at 2-8 degree temperature.

The volunteer had sued SII for Rs 5 crore, alleging that the vaccine shot he received at Chennai’s Sri Ramachandra Institute of Higher Education and Research, produced adverse reactions, “including neurological impairment and an inability to get back to the life before being inoculated”. The complainant also demanded that the ongoing trials in India of the vaccine candidate be immediately halted.

SII said in a statement: “While (SII) is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and (his) medical condition. The volunteer is falsely laying the blame for his medical problems on the Covid vaccine trial.”

The company added that 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. It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive”.

According to legal notice by the volunteer reviewed by FE, the volunteer, who signed the ‘Informed Consent Form’ on September 29, 2020, was administered a test for antibodies against Covid-19 to rule out prior infection. He received a vaccine shot on October 1. Currently, double-dose trials of the vaccine are being conducted in India on 1,600 volunteers.

A leading daily had quoted Dr S R Ramakrishnan, who was the lead investigator for the Chennai arm of the trial and had treated the patient, as saying that, “the subject was now alright”.

“He recovered very well and we treated him as per protocol and he even came back for a follow-up. All the expenses were borne by the hospital,” the newspaper quoted Ramakrishnan as saying further.

“The hospital’s institutional ethics committee had given a letter,” Ramakrishnan said, adding that ‘the adverse reaction was not due to the study vaccine, and this was also communicated to the Drug Controller General of India (DGCI), the apex regulator’.