Covid vaccines: Experts raise accountability concerns in case of side-effects

With days to go for the roll out of Covid-19 vaccines,scientific voices are concerned about the absence of visibility on where the buck stops in the event of side-effects linked to the vaccine.

Their worry stems from clinical trial-linked incidents like the one emerging from Bhopal, where participants have allegedly said that clinical trial protocols were not followed in terms of the informed consent that needs to be taken before vaccination and medical follow-ups after it, especially if there was a reaction.

Seek indemnity

The concern is exacerbated by the fact that one of the vaccines, Covaxin, received the restricted-use approval in a ‘clinical trial mode’. The regulatory pathway becomes more unclear as some vaccine-makers seek indemnity from the government against suits linked to their Covid-19 vaccines during the pandemic period, say researchers.

The Bhopal incident involves Bharat Biotech’s vaccine Covaxin, but the hospital conducting the trial, Bhopal’s People’s College of Medical Sciences and Research Centre, denied any wrong-doing. “Volunteers were not confined to 3-4 specific communities as alleged. No gas victims were herded by us. People’s Hospital strictly abided the exclusion and inclusion criteria duly approved by the GoI (Government of India)…,” the hospital said.

Bharat Biotech and collaborator, the Indian Council of Medical Research (ICMR), did not comment on the issue. However, Suneela Thatte, Head, R&D India, IQVIA, the contract research organisation doing the trial for Bharat Biotech, told BusinessLine: “IQVIA is bound by confidentiality agreements with sponsors, and we cannot comment on any ongoing study. However, we do maintain transparency of our operations to the regulatory authorities, disclosing all necessary particulars to the regulatory authorities as required by the law and applicable regulations.”

Responding to questions on the money paid to trial participants, she saidthe company followed Indian Good Clinical Practice norms, where volunteers could be reimbursed with an amount that did not act as an inducement. “We can confirm that the same was followed in this instance, and the reimbursement amount was approved by the Institutional Ethics Committee (IEC).

On consent from participants, she saidreports suggested that the Hospital Dean had confirmed that the Informed Consent discussion was carried out with all subjects in the trial and that the site has records of the same. “Our ongoing monitoring includes periodic reviews of all study documentation to ensure all processes are in place as per the study protocol.”

Anant Bhan, a researcher on global health, bioethics and health policy, observed the incident was of concern, not only as an isolated one but also as it “goes to scale”, and the vaccine was given to many more people in the clinical trial mode. As the vaccine is given in India and other countries, the clinical trials need to be of the highest quality, he said, calling into question the role the ethics committee, ICMR, the stake-holders.

Recently, a trial volunteer on the Serum Institute (AstraZeneca-OxfordUniversity) vaccine, too, had side-effects that he said was linked to the vaccine, something the company had denied.

Commenting on the call for indemnity, Bhan said the aim should be to protect research participants and those receiving the vaccines. If the government gives indemnity, then it should take responsibility in case of an adverse event. Government representatives, though, have indicated that the responsibility lies with the manufacturer, in case of an adverse event-linked issue.