The Indian Council of Medical Research (ICMR) has said it will wait for the Drug Controller General of India (DCGI) to take a call on the adverse event reported by a participant in the clinical trial on the Covid-19 vaccine candidate from the AstraZeneca-Oxford University combine.

The 40-year-old volunteer participated in the trial arm that took place at Chennai’s Sri Ramachandra Higher Education and Research Centre (formerly known as SRMC – Sri Ramachandra Medical College) and according to a petition on his behalf, the healthy individual experienced severe adverse events requiring hospitalisation. Linking the incident to the trial, the petition sought a compensation of Rs 5 crore and called for the stoppage of the vaccine trial, manufacturing and distribution.

Samiran Panda, ICMR Head of Epidemiology and Communicable Diseases Division told BusinessLine , "ICMR is aware of this adverse event. Preliminary information is that the examination does not indicate any causal association as yet. But we will wait for the DCGI to take the final call.” The ICMR is co-sponsor on the trial being done in India by Serum Institute of India, the vaccine-maker that has a production and distribution alliance on the AZ-Oxford vaccine.

BusinessLine has reached out to SRMC, AstraZeneca, Serum Institute and the DCGI for their response on the incident, and a response is awaited. AZ has had two global incidents reported out of the UK and Brazil, but reports indicated that they were not linked to the vaccine trial.

Trial participant’s petition

The petition on behalf of the participant to the trial sponsors, conductor and regulator pointed out that “there is nothing in the Participant Information Sheet to educate or warn the participants about any serious side-effects of the said vaccine, like the one suffered by him. All through the Participant Information Sheet, the categorical assertion has thus been that taking the vaccine is safe. Our client states that he believed the assertion about the ‘safety’ of the vaccine in the Participant Information Sheet and decided to volunteer to take the vaccine.” The volunteer suffered severe headache, vomiting, disorientation, mood-swings and a behavioural change, the petition said.

Multiple sources familiar with the trial said that the internal ethics committee watching over the trial had been alerted on the incident. It was seen to not be linked to the vaccine trial, they said, on conditions of anonymity, adding that they had reported the incident to the DCGI.

ICMR’s Panda further clarified, “All procedures that need to happen have happened in this case. We haven't come across anything similar from any other site.”

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Experts view

Experts point out that adverse events happen on not just a vaccine but any drug trial, and they could be serious at times. The important thing is to “examine whether this is causally linked to the investigational product,” said Panda.

“The Principal Investigator of the study site then informs about it to the site-specific ethics committee and DCGI also gets informed about it. There are stipulated guidelines in terms of reporting and examination of the causal link,” he added.

A representative with the clinical trial industry pointed out that there are at least five layers of review of the trial, the PI or the doctor at the hospital doing the trial, the company-sponsor, the independent ethics committee and finally the drug regulator’s expert committee. And in an international trial, as this one, there would also be the Data Safety Monitoring Board (DSMB) who will be looking at trial arms across different countries, he said, adding that the Indian clinical trial norms are the only ones to have compensation built into it as well.

The participant’s petition pointed out that the volunteer had been discharged in late October, stating that he had suffered “Acute Encephalopathy”. Further, it alleged that the hospital nor sponsors or regulator had followed up with him on his condition, after discharge.

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