Rio de Janeiro: Clinical trials of the Covid-19 vaccine being developed by British-Swedish pharmaceutical firm AstraZeneca and Oxford University will continue in Brazil despite the death of a volunteer, Brazilian health regulator Anvisa said recently.
According to a report in The Wall Street Journal on Wednesday, Oxford University said it had carried out a careful assessment of the case in Brazil and found that there were no concerns about the safety of the trial.
An independent assessment of the case did not present any concerns, AstraZeneca said.
The Wall Street Journal, citing local Brazilian press reports, said the volunteer was a man in his 20s from Rio de Janeiro. It was not immediately clear if the man received the vaccine or had been part of a placebo group.
An AstraZeneca spokesperson told Fox News that the company cannot comment on individual cases in an ongoing trial due to regulations.
However, they said the company has followed all required review processes.
“All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities,” the spokesperson said.
“These assessments have not led to any concerns about continuation of the ongoing study,” the spokesperson added.
In the US, clinical trials involving AstraZeneca were recently put on hold pending a FDA investigation into a “possible serious adverse event.”