There has been a death in the late-stage clinical trials of a Covid-19 vaccine being developed by University of Oxford and Swedish-British drugmaker AstraZeneca. What happened and what does this mean for the trials of the closely watched candidate, a version of which is at the forefront of India’s own Covid-19 vaccine race?
What happened and why is it important?
A volunteer in Brazil participating in the trials for the Oxford University-AstraZeneca vaccine candidate, AZD1222, died this week, according to the country’s health surveillance agency, ANVISA. While the regulator, University of Oxford and AstraZeneca, did not elaborate further, a report by CNN Brasil states that the volunteer was a 28-year-old male living in Rio de Janeiro and had died of Covid-19 complications.
Brazil is among the major grounds for testing Covid-19 vaccine globally, with phase 3 human trials in the country enrolling around 5,000 volunteers across the country.
As part of the trial, participants were either given the experimental Covid-19 vaccine or were administered doses of a previously approved vaccine against meningitis — a viral, bacterial or fungal infection that causes inflammation of the brain and spinal cord membranes.
Does this mean the AstraZeneca vaccine is unsafe?
So far, no. According to reports, the participant was not given a shot of AZD1222, which means his death was not a result of the trial vaccine.
AstraZeneca has said that this issue, like all significant medical events, was “carefully assessed” by trial investigators, an independent safety monitoring committee and regulatory authorities.
“These assessments have not led to any concerns about continuation of the ongoing study,” the firm has said in a statement.📣 Follow Express Explained on Telegram
What happens to the trial in Brazil?
Brazil’s regulator has said that the trial will continue.
Testing would have been suspended if the participant had been given the dose of trial Covid-19 candidate. However, as it has been suggested that this person was part of the meningitis vaccine control group, there is no question of the trial running into problems as a result of this death.
What other issues have cropped up in the course of this trial?
This may be the first reported death during this trial, but the candidate did hit a roadblock in September, when a participant in the UK reportedly given the experimental Covid-19 vaccine developed a serious adverse reaction. The trials of this vaccine were put on pause across the globe as a result.
Following reviews that led investigators, a safety monitoring board and the UK government to conclude that the reaction was not caused by the vaccine, trials had resumed at most sites except in the US. The US Food and Drug Administration is still looking into this adverse event and is yet to approve the restart of the trials there.
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What is the status of the trials for this candidate in India?
Pune-headquartered Serum Institute of India (SII), which has an agreement with AstraZeneca to manufacture this vaccine for low- and middle-income countries, is currently conducting late-stage trials of the candidate in India targeting around 1,600 participants.
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