Serum Institute of India's case against a vaccine trial volunteer raises the need for transparency in addressing adverse events in medical trials.
The Serum Institute of India, which is conducting phase-third trials for a COVID-19 vaccine candidate in India, got into a controversy when it filed a lawsuit of Rs 100 crore against a trial volunteer.
The issue happened after a trial volunteer of Oxford-AstraZeneca Covishield vaccine reported adverse effects and medical conditions ten days after he was given the first dose.
The volunteer, who complained of memory loss and change in personality, sued the SII for a compensation of Rs 5 crores. The SII, in turn, filed a defamation lawsuit of Rs 100 crores against him on the pretext that his illness did not have anything to do with the vaccine trial.
The Institutional Ethics Committee (IEC) of the Covishield trials in India validated the same. The IEC, which is backed by the Data and Safety Monitoring Board (DSMB) and DCGI (Drugs Controller General of India), said that his symptoms were not from the vaccine shot.
Amid this controversy, the question of addressing such adverse events in medical trials needs to be considered. It is always better to engage with the volunteers rather than taking legal action against them.
The Firstpost quoted health researcher Anant Bhan as saying, "It’s an unusual response because the reasons for volunteers to participate are altruistic. If there is a concern that a volunteer has, it’s good to engage with them and understand what those concerns are, and to make efforts to try and address them. It’s in the interest of the sponsor, and is also a signal to other participants already in the trial, and potential participants."
He added that it was better to be transparent or otherwise it would spook the people when the vaccine became available.
The SII also had a conflict of interest in the case as it has a financial stake in the trial. If the vaccine trial is successful, the SII will be manufacturing doses of the vaccine in the next few months.
"The regulator is being paid taxpayer money to be able to provide adequate oversight in these circumstances. The expectation is for the regulator to come forward and speak on the issue," Bhan told Firstpost.
Many other experts also questioned the handling of the matter by the SII.
Procedures adopted in case of adverse events
Every side effect or adverse event in medical trials is recorded and investigated as part of the checks and balances put in place.
The Institutional Ethics Committee (IEC) receives a report in 24 hours and conducts an initial assessment. It is then sent to the DCMB with more information, which then establishes whether there is a causal link or if the vaccine caused the side effect/adverse event. The DCGI receives a consolidated report within seven days of the event.
The DCGI takes the final call in whether the causal link was established or not. If it is established, there is a provision of compensation and the amount laid out by the DCGI under the Clinical Trial Rules 2019.
Addressing it legally
There are legal provisions that a qualified volunteer can take. It depends on the consent form too before the trial as it details the participant's rights and if they can contest the decisions of the regulators. The procedure is rather underdeveloped in the country.
Bhan told Firstpost that if he disagreed with the trial regulator, there was no way to appeal to the regulator and he could only take the legal route.
"In that sense, a participant is well within their rights to choose a legal pathway. We haven’t seen a lot of action happening in terms of participants suing companies for harms during clinical trials. But that will likely change as we move towards better literacy levels," said Bhan.
Fast-track trials can be risky
The COVID-19 vaccine trials that have been fast-tracked are fraught with certain risks. It takes time to analyse if and how the immune system reacts to the vaccine candidate. It requires a long span of time and there is variation in how it works out from one individual to another.
The scientific point of view suggests that some observations would be missed in such trials.
Therefore, the need for openness and transparency requires that every adverse event is evaluated.
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