DCGI silent on Covid-19 vaccine effects; Serum seeks Rs 100 crore damages from Tamil Nadu volunteer who sued company

The Indian drug regulatory authority's silence on two incidences of serious adverse reactions during the Covid-19 vaccine trials over the last three months raises grave concerns on the credibility of the clinical trial process supervised by the Drugs Controller General of India (DCGI). The manufacturers have, however, vouched for the safety of their vaccines.

The most recent incident of such an adverse effect has been reported from the Sri Ramachandra Institute of Higher Education and Research, Chennai, where a volunteer was given a shot on October 1 as part of the Serum Institute of India’s (SII) clinical trial of the Covid-19 vaccine, but developed complicated neurological conditions 10 days later, necessitating hospitalisation.

While a Chennai-based neurologist linked the disorder to the Covid-19 vaccine and the recipient sent a legal notice to the SII seeking Rs 5 crore compensation, the company in a statement on Sunday strongly refuted any such linkage and demanded Rs 100 crore from the volunteer in damages for maligning the company.

Read: Serum Institute rejects charges levelled by Covid-19 vaccine trial participant, threatens to seek damages

"The allegations are malicious and misconceived. While the SII is sympathetic with the volunteer's medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medial problems on the Covid-19 vaccine trial," the company said.

"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."

Health Ministry sources told DH that an institutional ethics committee that probed the adverse events within 48 hours found no causal link between the vaccine and the neurological complications that the Chennai recipient developed.

But the DCGI, which was informed by the hospital within seven days, is yet to release the findings of its probe even after six weeks.

Read: Covishield vaccine trial participant alleges neuro breakdown; demands Rs 5 crore compensation from Serum Institute

"The initial investigations by the institutional ethics committee did not show any causal link. The DCGI is looking into it and will release its observations. It will inform the ICMR and SII," Samiran Panda, head of epidemiology and communicable diseases at ICMR, told DH.

The SII incident is the second case of serious adverse reaction seen in Covid-19 vaccine trials in India. For the last three months, the regulator is also keeping mum on another case of adverse effect reported in August during Bharat Biotech’s vaccine trial.

"The adverse event during phase I clinical trials was reported to the DCGI within 24 hours of its occurrence and confirmation. It was investigated thoroughly and determined as not vaccine-related," the Hyderabad-based vaccine-maker had stated. 

In contrast, the DCGI promptly paused the Astra-Oxford-SII vaccine trial for about a week when two cases of serious adverse reactions were reported in the UK and Astra suspended the clinical trial all over the world to review the data.

"In the absence of any formal and authoritative statements on the adverse events, scepticism begins to sound reasonable. The trouble, of course, is that this bureaucratic opacity is common to Indian regulatory processes in every area. It is based on the paternalistic assumption that 'authority knows best', which is a familiar attitude of any 'authorities' in India," commented Satyajit Rath, a visiting professor at the IISER Pune.