Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, stating it had received data from an investigation into the matter.
The University of Oxford’s Brazilian trials will continue after the death of a volunteer, the university said, adding an independent review had revealed no safety concerns.
“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,” a spokesman for the university said in a statement.
The vaccine has been licenced to AstraZeneca.
The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, separately said that the volunteer was Brazilian but did not say where the person lived.
AstraZeneca shares turned negative and were down 1.7%.
The federal government already has plans to purchase the UK vaccine and produce it at its biomedical research center FioCruz in Rio de Janeiro, while a competing vaccine from China’s Sinovac is being tested by Sao Paulo state’s research center Butantan Institute.
Brazil has the second deadliest outbreak of coronavirus, with more than 154,000 killed by COVID-19, following only the United States. It is the third worst outbreak in terms of cases, with more than 5.2 million infected, after the United States and India.
The Brazilian trial would have been suspended if the volunteer who died had been part of the active arm, a source familiar with the situation said on Wednesday.
The comment would suggest the volunteer was part of the comparative control group, which is given a meningitis jab.
Participants and investigators are not told which group they are in.
Also, earlier this Wednesday, the Brazilian Health Ministry announced that its Minister Eduardo Pazuello has tested positive for the virus, making him the latest Brazilian official, including Bolsonaro, to do so.
(Updated at 3:31 pm)