Brazil halts trial on Chinese Covid-19 vaccine following adverse event
Nov 11 2020
Anvisa was notified of a serious side effect in one of the people taking part in the trials on 29 October, according to a statement quoted by Globo, but details of the incident were not provided. "It's a death that has no relation with the vaccine and as such it is not the moment to interrupt the trials".
The vaccine is undergoing late-stage tests in Brazil involving 3,100 volunteers in Sao Paulo and Bahia states, and would be imported from Pfizer's factories in the United States and Europe, the spokesman said, giving no further details.
The company said the head of Instituto Butantan reassured it the event that caused the trial's pause was unrelated to the vaccine.
U.S. President Donald Trump, who lost the U.S. election and has repeatedly blamed China for being the source of the coronavirus, has accused Pfizer of delaying its announcement until after the vote.
This is the first time human trials for a Chinese-developed COVID-19 vaccine have been suspended. On Tuesday morning, he said on his Facebook page that the suspension was "another victory for Jair Bolsonaro".
"Sinovac will continue to communicate with Brazil on this matter".
A World Health Organization spokeswoman sought to play down the politics. "The clinical study in Brazil is strictly carried out in accordance with GCP requirements and we are confident in the safety of the vaccine".
Sao Paulo state health authorities said in a press conference on Tuesday that Anvisa sent a single email at 8:40 p.m. saying the tests should be halted.
China has repeatedly hit back on criticisms that it is rushing public use of the vaccine candidates. He publicly rejected it last month, saying Brazilians would not be used as guinea pigs.
Last month, Brazil's president Jair Bolsonaro said the central government would not buy CoronaVac. Bolsonaro, who regularly expresses anti-Chinese sentiment, has previously said the federal government will not buy the vaccine.
No other country conducting trials of Sinovac's experimental vaccine has announced a suspension. Since July, Sinovac has launched large-scale trials in several countries including Brazil, Indonesia, and Turkey.
Temporary halts of drug and vaccine testing are relatively common.
Four vaccines are being tested in Brazil seeking Anvisa approval, including those developed by Oxford University/AstraZeneca Plc and Johnson & Johnson's pharmaceutical subsidiary Janssen. "This is the vaccine that Doria wanted to force all in Sao Paulo to take". According to an global clinical trial registry, the experiment in Brazil had planned to recruit 13,060 participants.