“It is very simple. The more that the people know, the more they will trust,” said one bioethics expert on the lack of transparency around a serious adverse event linked to Covishield, Oxford AstraZeneca's COVID vaccine, being manufactured by Serum Institute of India, here.
On 29 November, a volunteer in the Covishield vaccine trial in Chennai alleged that he had suffered serious side effects, including a “virtual neurological breakdown and impairment of cognitive functions.” He sent a legal notice demanding Rs 5 crore as compensation, while also asking for the trials to be halted.
Dismissing the participant’s claim as “malicious and misconceived”, the institute has pressed for Rs 100 crore as damages.
Serum Institute has further defended its countersuit by saying,
“The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition."
There are multiple concerns here, but one that has especially worried experts is the abject opacity and lack of transparency by the stakeholders involved.
They make a clear point: Regardless of whether the adverse event is causally linked to the vaccine or not (that is for the regulators to decide), why has no information been given out to the public about the proceedings?
The Background
The volunteer had signed up for the vaccine trial on 29 September, after the information provided to him in the Participant Information Sheet claimed that the vaccine being developed by AstraZeneca and Oxford was safe, reported PTI.
He was administered the vaccine on 1 October, after testing negative for COVID-19 antibodies a day before. After ten days of stability, the participant went through severe episodes of vomiting and headache and experienced several neurological complications, including acute encephalopathy.
While expressing sympathy with him over his medical condition, SII has accused him of ‘falsely blaming’ the vaccine for his medical problems despite being made ‘aware’ of the fact that ‘the complications he suffered were independent of the vaccine trial he underwent’.
Why Keep It Under Wraps?
In conversation with FIT, Dr Anant Bhan, Adjunct Professor & Researcher in Bioethics at Mangaluru’s Yenepoya University, said, “There are established procedures in India on how to tackle serious adverse events (SAEs). These events do happen - that, by itself, is not necessarily a major problem. But given that this is a new vaccine for a novel virus, it would be good for all parties involved to be more proactive and transparent. Public trust in vaccines is at stake.”
This isn’t the first time that an adverse event has been reported in a trial for the vaccine developed by AstraZeneca and the University of Oxford. But the stark contrast between how the same was handled in the UK and back in India has raised serious transparency concerns.
“One would have expected them to be more proactive considering the past incidents. The regulators were more open about it in the other countries. They made a public announcement a few days after the SAE happened and also shared the process that would be followed thereafter. The trials were halted temporarily around the globe. In India, on the other hand, we got to know about the case primarily because the participant himself decided to go public weeks after the complications first arose.”Dr Anant Bhan
“It is very simple. The more that the people know, the more they will trust. This is just creating suspicion,” said Dr Amar Jesani, Editor, Indian Journal of Medical Ethics.
“How could they have kept it under wraps for so long? How could nobody have known anything about a neurological condition in a formerly healthy participant? There has been no official statement so far from any of the regulators or the ethics committee. The job of these bodies is precisely this - to provide protection to volunteers and to ensure a safe vaccine reaches the public. But everybody has been mum for 1.5 months. There is absolutely zero transparency.”Dr Amar Jesani
Dr Bhan explains the grave implications of such an approach, “Such lack of transparency is neither conducive for clinical research nor for public trust in the vaccine. Usually, it takes around a month since the incident for some decision or declaration to be made. There are multiple stakeholders - the investigator, the site ethics committee, the sponsor and the regulator. But here, it has been more than a month, so one would expect at least some level of clarity. They could have decided to be more transparent like the other regulators globally have been.”
'This Will Discourage Volunteers'
“Why weren’t the trials halted? Why didn’t the data safety monitoring board come out with a statement? When it can happen in the UK, why not here? Even when the AstraZeneca-Oxford candidate announced a global pause on the trials, SII didn’t halt them here until the company was pulled up by the DCGI,” Jesani added.
“This is extremely careless behaviour. So many people have come forward to volunteer out of altruism. Instead of helping them out and providing for them, you are turning your back and filing a defamation case. Irrespective of whether the SAE is related to the vaccine or not, it is the moral responsibility of the company to assure the participant is taken care of. Instead, there are threats and countersuing.”Dr Amar Jesani
Importantly, this isn’t necessarily specific to SII’s Covishield. When a trial volunteer for India’s indigenous vaccine candidate ‘Covaxin’ developed flu-like symptoms in August, there was, again, no single announcement about the case.
“There are so many questions here. The way India is handling all of this is astounding. The regulators must investigate and come out with a full explanation - not just one statement. They have to clarify who will take care of the person, how he will get compensated and what exactly went wrong. Even if there is no causal link established between the neurological condition and the vaccine shot, there needs to be an announcement. We need clarity,” Dr Jesani asserted.
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