Volunteer in Oxford-AstraZeneca COVID-19 vaccine trial dies in Brazil; officials say testing to continue
Oxford confirmed the plan to keep testing, saying in a statement that after careful assessment 'there have been no concerns about safety of the clinical trial'
Rio de Janeiro: A volunteer participating in clinical trials of the COVID-19 vaccine developed by Oxford University has died in Brazil, officials announced Wednesday, though media reports said he had received a placebo, not the test vaccine.
It is the first death reported in the various coronavirus vaccine trials taking place worldwide.
However, organizers of the study said an independent review had concluded there were no safety concerns and that testing of the vaccine, developed with pharmaceutical firm AstraZeneca, would continue.
Media reports said the volunteer was a 28-year-old doctor working on the front lines of the pandemic who died of complications from COVID-19 .
Brazilian newspaper Globo and international news agency Bloomberg said he was in the control group and had received a placebo rather than the test vaccine, citing sources close to the trials.
"Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial, and the independent review in addition to the Brazilian regulator have recommended that the trial should continue," Oxford said in a statement.
AstraZeneca said medical confidentiality meant it could not give details on any individual volunteer, but that independent review had "not led to any concerns about continuation of the ongoing study."
Brazil's national health regulator, Anvisa, confirmed it had been notified of the case on 19 October.
The D'Or Teaching and Research Institute (IDOR), which is helping organize the tests in Brazil, said the independent review had "raised no doubts about the safety of the study, and recommended it continue."
Oxford and AstraZeneca previously had to suspend testing of the vaccine in September when a volunteer in Britain developed an unexplained illness.
Trials resumed after British regulators and an independent review concluded the illness was not a side effect of the vaccine.
Half the volunteers in the final-stage clinical trial - a double-blind, randomized, controlled study - receive a placebo, IDOR said.
Around 8,000 volunteers have been vaccinated so far in Brazil, and more than 20,000 worldwide, it said.
Study participants must be doctors, nurses or other health sector workers who come into regular contact with the virus.
The deceased volunteer was a young doctor who had been treating COVID-19 patients since March in the emergency rooms and intensive care units at two hospitals in Rio de Janeiro, Globo said.
He graduated from medical school last year, and was in good health prior to contracting the disease, family and friends told the newspaper.
Find latest and upcoming tech gadgets online on Tech2 Gadgets. Get technology news, gadgets reviews & ratings. Popular gadgets including laptop, tablet and mobile specifications, features, prices, comparison.
Italy's special commissioner for the virus emergency said he expected Pfizer's authorization from the European Medical Agency to be completed in time for the first vaccines to be administered in January
As of 28 November, India has 6,731 cases per million population, according to the Union health ministry's data. In comparison, USA has 40,000 cases per million and UK has 23,361.
Oxford-Astrazeneca trial data show vaccine is at least 70 percent effective and easy to store as well
They looked at two different doses - half-dose followed by a full dose at least one month later was 90% effective while those give two full doses one month apart, was 62% effective.