It was a heroic moment of sorts when early volunteers got the first shots of an experimental Covid-19 vaccine, just months after the pandemic began its deathly roll across geographies.
The novel coronavirus was an unknown and the vaccine had been through fast-track regulatory processes that telescoped years of work, into a few months. But that did not seem to deter the healthy volunteers who took the experimental vaccine being given to humans for the first time. Televised images of some of them in the US provided a rare peep for the public into this insulated world of clinical trials.
Thousands of healthy volunteers across the world have been signing-up to take the early vaccine shots, an act often described as altruism. The act is courageous too, because there are unknown risks, especially in early stages of the trial.
Global regulators have stringent systems in place, so no one is exploited or coerced to participate in a trial. The effort also seeks to ensure that volunteers and patients sign an “informed consent” form, after fully understanding the side-effects or adverse events they may experience during the trial.
Importance of trials
Much hinges on trials for the company that sponsors it and the public, if indeed a new drug or vaccine is successfully rolled out for mass use. The more transparent and above-board the processes are, the more it bolsters confidence in the drug, or vaccine, in this case. And the less chance of anti-vaxxers being able to use information on lapses as ammunition against a possibly effective product.
If there’s one kind of publicity a clinical trial could do without, it involves mishandling of complaints raised by volunteers who sign-up for the trial, for no more a reason than the greater common good.
Unfortunately, the “system’s” overall response to a public complaint from a volunteer who participated in a Covid-19 vaccine trial at Chennai’s SRMC hospital (Sri Ramachandra Higher Education and Research), leaves much to be desired. The volunteer’s lawyer alleges serious adverse events linked to the trial. And a legal notice on his behalf said he experienced neurological problems and disorientation, among others.
The vaccine being tested was AstraZeneca-OxfordUniversity’s Covid-19 candidate and the trial was done by the Serum Institute of India (SII), with the Indian Council of Medical Research as (ICMR) as co-sponsor.
Refuting the volunteer’s allegations and compensation claim of ₹5 crore, SII labelled them “malicious” and countered it with a ₹100 crore suit for damages. Making a bad situation worse was the silence from the drug regulator and co-sponsor, until media representatives checked independently and were told there was no link between the adverse event and the vaccine trial.
The company-sponsors and regulator walk a fine technical line in not going public on the incident, as they say, internal reviews showed no links between the adverse event and the trial. However, the volunteer’s concerns require a public response, as a responsibility to the individual and in the interest of keeping the trust in clinical trials in future.
A similar responsibility is also owed to the public, as the Covid-19 vaccine intervention is possibly the biggest public health vaccination programme yet. And a lack of clarity on the vaccine will contribute greater hesitancy to take it.
A recent study by community social media platform LocalCircles found 59 per cent of the 8,900-plus respondents from districts across the country saying they would not rush to take a vaccine, if indeed one is available in the near future. A clear call for greater transparency, to keep the faith in public health interventions and to prevent an adverse event from ruining the spirit of altruism.