SAO PAULO/FRANKFURT: Brazilian health authority Anvisa added on Wednesday that the trial will continue, although a volunteer died in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University.
After a careful evaluation, Oxford confirmed plans to continue testing in a statement that “there were no concerns about the safety of the clinical trial.” AstraZeneca immediately declined to comment.
Sources familiar with the matter told Reuters that the trial would have been halted if the deceased volunteer had been vaccinated against COVID-19. This suggests that the person was in the control group who received the meningitis jab.
The federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, said an independent review committee recommended continuing the trial. The university confirmed earlier that the volunteers were Brazilian, but they no longer provided personal information.
In a statement, the Brazilian university said, “Everything is going as expected, without a record of serious vaccine-related complications in which volunteers participated.”
Of the 10,000 volunteers planned in clinical trials so far, 8,000 have been recruited to receive the first dose in six cities in Brazil, and many have already received the second dose, a university spokesman said.
CNN Brasil reported that the volunteer was a 28-year-old male living in Rio de Janeiro who died of complications from COVID-19.
Anvisa did not provide details, citing the medical confidentiality of those who participated in the clinical trial. AstraZeneca stock fell 1.8%.
The Brazilian federal government plans to purchase and produce a UK vaccine from Pio Cruz, a biomedical laboratory in Rio de Janeiro, UK, while a competitive vaccine from China’s Sinovac Biotech is being tested at the Butantan Institute of Sao Paulo State.
Brazilian President Zaire Bolso Naru said Wednesday the federal government would not buy the Sinovac vaccine.
Brazil is the second most deadly coronavirus after the United States, killing more than 154,000 people. It is the third-largest case with more than 5.2 million people infected, after the United States and India.