SII trial 'adverse event' not to effect Covid-19 vaccine timeline: Govt

At present, SII vaccine trials are in phase 3 after all investigation, and Bharat Biotech clinical trials is also in phase 3

The Union Health Ministry on Tuesday said that initial findings from the Serum Institute of India’s ongoing vaccine trial didn’t necessitate stoppage of the trial despite the reporting of a serious adverse event on the basis of the causality assessment.

"Initial causality assessment didn’t necessitate a stoppage of the SII trial,” Balram Bhargava, director-general of the Indian Council of Medical Research said at a press conference.

Bhargava and Union Health Secretary Rajesh Bhushan said that reports from the Institutional Ethics Committee, Data Safety, and Monitoring Board as well as a report from the Principal Investigator of the study have been submitted to the Drugs Controller General of India.

Coronavirus vaccine news live updates on DH

The two officials, however, were silent on why India’s drug regulator didn’t speak up not only on the serious adverse event reported in October in the SII trial but also maintained silent on another serious adverse event reported in August during the trials of an indigenous Covid-19 vaccine developed by Bharat Biotech, Hyderabad.

When asked why the government on its own did not disclose the serious adverse event in the SII trial, Bhushan snapped, “Don’t assume that the processes were not complied with.”

A 40-year-old Chennai based volunteer had developed serious neurological conditions after being administered a single shot of the SII vaccine. He didn’t take the second shot and sought a compensation of Rs 5 crore from the company, which in turn demanded Rs 100 crore from the individual for maligning the company claiming that the illness had no links to the shot.

Also read: Ensure highest level of ethical standards in Covid-19 vaccine trial: Parliamentary panel

Asked about the Rs 100 crore damage claim, Bhushan said, “commercial interests would dictate certain strategic action on part of the company, but the government of the day has nothing to do with it.”

He also said that ICMR had no role in endorsing the Rs 100 crore damage claim by the company.

The government’s role, Bhushan said, was to educate people to ensure that people had been made aware of the safety and effectiveness of a vaccine. Next week the ministry is likely to share a document on the vaccination guidelines with the states in which there would be a chapter on communication to deal with issues like vaccine hesitancy.

While Bhushan repeatedly said he would not comment much on the incident because it was a legal matter, the victim’s lawyer clarified that he was yet to move the court and was waiting for the SII to respond to its legal compensation notice within the stipulated time.