Brazil’s health regulator announced that it has “interrupted” clinical trials of a coronavirus vaccine developed by Chinese pharmaceutical company Sinovac Biotech after a “serious incident” registered on Oct. 29 involving a volunteer recipient.
ANVISA did not provide further details about what happened but indicated in a statement that such incidents could include death, potentially fatal side effects, severe disability, hospitalization and other “clinically significant events.”
Trials with the Sinovac vaccine are also being carried out in Turkey, Indonesia and Bangladesh.
Sao Paulo’s Butantan Institute, one of Brazil’s leading biomedical research centers, was carrying out the Phase 3 tests which involved 9,000 volunteers.
Sao Paulo had signed a deal with Sinovac to buy 60 million doses by the end of February and Governor Joao Doria said the immunization program could begin as soon as January 2021.
However, President Jair Bolsonaro has said his government will not buy a Chinese-made COVID-19 vaccine, which prompted some to question whether he was using politics to make public health decisions.
“The Brazilian people will not be anyone’s guinea pig,” Bolsonaro said on social media in October.
Brazil has reported more than 5.6 million COVID-19 cases since the pandemic began, making it the world’s third most-affected country after the US and India and second only to the US in the number of deaths, with nearly 163,000 registered so far, according to Johns Hopkins University.