Phase 3 studies on the Oxford’s COVID-19 vaccine candidate would continue in Brazil despite the death of a volunteer who had participated in the vaccine trial, informed the Brazilian health authority Anvisa.
Oxford confirmed that there have been no concerns about safety of the clinical trial. Meanwhile, the vaccine manufacture partner AstraZeneca was quoted as saying that it could not comment on individual cases but it 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,” said Astra Zeneca. “These assessments have not led to any concerns about continuation of the ongoing study.”
However, since only around half the volunteers in the trial are given the actual Oxford University COVID-19 vaccine, and the second group are being given an existing licensed vaccine for meningitis neither the participants nor their families know which vaccine they are being given.
The Brazilian newspaper O Globo reported that the volunteer had been given a placebo and not the trial vaccine, citing unnamed sources.
Brazil’s health authority has given no details about the death, citing confidentiality protocols. The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, said an independent review committee had also recommended the trial continue.
So far, 8,000 of the planned 10,000 volunteers in the trial have been recruited and given the first dose in six cities in Brazil, and many have already received the second shot, said a university spokesman.
Trials of the Oxford vaccine were paused last month after a reported side effect in a patient in the UK, but were resumed days later when it was deemed safe to continue. The phase 3 trials in the US remain on hold while the regulatory agency there conducts its own assessment.
Brazil has the third largest number of cases, with more than 5.2 million infected, after the United States and India.