AstraZeneca-Oxford Covid vaccine trials: Volunteer death could fuel public uncertainty

PT Jyothi Datta Mumbai | Updated on October 22, 2020

In India, Serum Institute has an alliance on the production and distribution of AZ-Oxford University vaccine.

The death of a 28-year-old Brazilian volunteer participating in a clinical trial of the Covid-19 vaccine candidate from the AstraZeneca-Oxford University combine, may not have stopped global trials in different countries, including India.

It could, however, fuel uncertainty among people, ambivalent on whether they will take the Covid-19 shot, if there is one. Especially so, since there is also a section of people questioning the speed and safety of these trials.

Also read: AstraZeneca Covid-19 vaccine: Volunteer dies, but the trial will continue, says Brazil

AstraZeneca said in its response to BusinessLine, “We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality and clinical trial regulations, but we can confirm that all required review processes have been followed. All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study.”

A University spokesperson has been quoted by Bloomberg as saying, “Oxford has no concerns about the safety of the vaccine trial after an independent and careful review, and Brazil’s regulators have recommended that it continue.”

Initial reports indicate, the death of the volunteer was not linked to the Covid-19 vaccine candidate, which is why trials have not been stopped. If the volunteer had received the vaccine-probable, that would have brought the global trials to a grinding halt.

Unsettling realities

The young volunteer has reportedly died of Covid-19 and though the Covid-vaccine link does not exist at present, it is still likely to unsettle fence-sitters when it comes to taking the vaccine, experts agree.

Unattributed reports indicate, the volunteer had been given a meningitis shot. Clinical research experts say, if that report were true, it is part of accepted practice to give a widely used vaccine, compared to an inactive placebo. The tragic incident will nevertheless give people a more realistic picture of a vaccine, that it may not be 100 per cent effective and carries inherent risks, says an expert.

US approval, pending

The incident comes even as AstraZeneca awaits a go ahead in the US to resume trials, after it had been paused following an earlier adverse event involving a volunteer in the UK. Trials had been stopped across the world, last month, following the pause by the company, but it had since resumed across countries including India. Reports suggested that a green signal to resume trials in the US were expected this week.

Also read: ‘Serum India, Bharat Biotech to start trials in coming months’

In India, Serum Institute has an alliance on the production and distribution of the AZ-Oxford University vaccine. They have not commented on the development either. The Indian regulatory authority too will need to be kept informed of the incident.

Also read: Very large portion of Covid-19 vaccines likely to be manufactured in India: Gates Foundation CEO

The last two month have seen a host of companies pausing trials on adverse events involving their vaccine-candidates, from AstraZeneca in September to the most recent pause from Johnson and Johnson.

Scientific voices have clarified that temporary suspensions illustrate that the safety protocols are working. But a death, though reportedly distant from that trial, will continue to raise questions in the minds of people. And it would be in the sponsors best interest to be more transparent with the details.

Published on October 22, 2020

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