October 23, 2020 2:06:04 pm
A pedestrian walks past signage outside an AstraZeneca Plc research and development facility in Shanghai, China, Monday, June 8, 2020 (Bloomberg Photo: Qilai Shen).
There it’s been a death in the last-stage clinical trials of a Covid-19 vaccine being developed by the University of Oxford and the Swedish-British pharmaceutical company AstraZeneca. What happened and what does this mean for the closely watched candidate trials, a version of which is at the forefront of India’s Covid-19 vaccine race?
What happened and why is it important?
A volunteer in Brazil participating in trials of the University of Oxford’s AstraZeneca vaccine candidate, AZD1222, died this week, according to the country’s health surveillance agency ANVISA. While the regulator, the University of Oxford and AstraZeneca, did not elaborate, a CNN Brazil report claims that the volunteer was a 28-year-old man living in Rio de Janeiro and had died from complications from Covid-19.
Brazil is among the top reasons for testing the 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 given the experimental Covid-19 vaccine or were given doses of a previously approved vaccine against meningitis, a viral, bacterial, or fungal infection that causes inflammation of the brain and spinal cord membranes. .
Read also | Deceased AstraZeneca Trial Volunteer Did Not Receive Vaccine: Bloomberg Report
Does this mean that the vaccine is not safe?
So far no. The participant reportedly did not receive an injection of AZD1222, meaning that his death was not the result of the test vaccine.
AstraZeneca has said that this problem, like all major medical events, was “carefully evaluated” by the trial investigators, an independent safety monitoring committee, and regulatory authorities.
“These evaluations have not raised any concerns about the continuation of the ongoing study,” the firm said in a statement.📣 Follow Express explained on Telegram
A participant is given a vaccine in a Covid-19 trial. (File photo)
What about the trial in Brazil?
The Brazilian regulator has said the test will continue.
The tests would have been suspended if the participant had been administered the dose of the Covid-19 test candidate. However, as it has been suggested that this person was part of the meningitis vaccine control group, there is no question that the trial will have problems as a result of this death.
What other problems have come up in the course of this test?
This may be the first reported death during this trial, but the candidate hit a roadblock in September, when a participant in the UK who allegedly received the experimental Covid-19 vaccine developed a serious adverse reaction. As a result, trials of this vaccine were put on hold around the world.
Following reviews that led researchers, a safety monitoring board, and the UK government to conclude that the reaction was not caused by the vaccine, trials were resumed at most sites except the US. The US Food and Drug Administration is still investigating this adverse event and has yet to approve the restart of trials there.
Also in Explained | What is the new organ that scientists have discovered in the throat?
What is the status of this candidate’s trials in India?
Pune-based Serum Institute of India (SII), which has an agreement with AstraZeneca to manufacture this vaccine for low- and middle-income countries, is conducting late-stage trials of the candidate in India targeting about 1,600 participants.
© The Indian Express (P) Ltd
.
