Participants in Serum Institute of India vaccine trial seek clarification from ICMR

Mumbai | New Delhi: Some participants of the Serum Institute of India’s Covid-19 vaccine trials have asked for an explanation on why they were not informed of an adverse event that took place during the testing.
These participants have reached out to the principal investigators of the trials and the director general of the Indian Council of Medical Research, seeking the clarification.

The move comes after one participant in the Covishield vaccine trial who developed medical complications sent a legal notice to Serum Institute and India’s drug regulator on November 21. According to the notice, the person allegedly suffered a serious adverse event after being administered the under-trial vaccine and has demanded compensation of ₹5 crore. The person also contended that the company did not publicly disclose the adverse event.

Serum Institute recruited 1,600 people to take part in its Covid-19 vaccine trial that it is developing with the ICMR.

Some of the trial participants told ET they are considering taking legal action against the company, the drug controller general of India and ICMR.

“We were given the second dose in November and this adverse event took place in October. The least that the principal investigators could have done is inform us about this episode,” said one participant. ET is not divulging the names of the participants keeping in mind their privacy.

Another participant said they felt cheated because they were not told about the incident.

“It does make me angry that there has been no communication. I feel bad for the person who has gone through so much and has been dismissed like this, without any comfort and assurance,” this individual said.

Serum Institute, responding to the legal notice, has denied the allegations and said that it will seek ₹100 crore in damages from the participant for defaming the company. Serum Institute also said there was no correlation between the vaccine trial and the medical condition of the participants.

“Instead of threatening the trial participants with legal notices, the least that the company should have done is disclose the adverse event,” another trial participant told ET.

The Covishield vaccine that Serum Institute is testing is based on technology transferred from AstraZeneca and the University of Oxford. AstraZeneca and Oxford had to pause their own trials in September after a couple of adverse events were reported in the UK. The trial resumed after the data safety monitoring board that governs clinical trials concluded that the adverse event was not caused due to the vaccination.

At that time, Serum Institute did not halt its trials because the company said there was no adverse event in India.

The All India Drugs Action Network (AIDAN), a patient rights group, said the drug regulator must inform the public why the trial was not halted.

“We would also like to know what protocols are being followed to investigate the SAE (serious adverse event) and reach a conclusion and inform about the role of the institutional ethics committee, DSMB (Data and Safety Monitoring Board), SEC (Subject Expert Committee) and CDSCO (Central Drugs Standard Control Organisation) in this process,” said Malini Aisola from AIDAN.