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Brazil’s national health regulator allowed clinical trials of a Covid-19 vaccine developed in China to resume on Wednesday, two days after suspending them in what critics called a decision tainted by politics.
The regulatory agency, Anvisa, said it had now received more details about the nature of the “adverse incident” that led it to halt end-stage trials of the CoronaVac vaccine, and that it had “sufficient information to allow vaccination to resume.” .
Public health officials had said the incident that led to the suspension, the death of a voluntary recipient, which police are investigating as a suicide, had no connection to the vaccine.
However, far-right president Jair Bolsonaro, who has criticized CoronaVac as the vaccine “from that other country,” had claimed the regulatory decision as a victory.
CoronaVac has been embroiled in a complicated political battle in Brazil, where its most visible sponsor has been the governor of Sao Paulo, Joao Doria, a major opponent of Bolsonaro.
The president has endorsed another vaccine, developed by the University of Oxford in Great Britain and the British-Swedish pharmaceutical firm AstraZeneca.
Bolsonaro, who has criticized CoronaVac as “Joao Doria’s Chinese vaccine” and prevented the federal government from buying it, had claimed the regulatory decision as vindication.
“Get another win for Jair Bolsonaro,” he wrote on Facebook on Tuesday, referring to himself in the third person.
Bolsonaro faces criticism from experts for his handling of the pandemic, which has included downplaying the virus, opposing lockdown measures and relentlessly promoting the drug hydroxychloroquine even though studies show it to be ineffective against Covid-19.
‘Technical’ decision
Even when he changed course, Anvisa defended his decision, which he said was purely “technical.”
He said the public health center coordinating the study in Brazil, the Instituto Butantan in Sao Paulo, had not sent him the cause of death, an independent security review or a required incident report until Tuesday.
The decision “took into consideration the data known to the agency at the time,” he said.
Developed by the Chinese pharmaceutical company Sinovac Biotech, CoronaVac is one of the most promising candidates to end the pandemic.
It is currently in Phase 3 trials, the final stage of testing before regulatory approval.
It is being tested on about 10,000 volunteers in Brazil, the country with the second highest death toll in the pandemic after the United States, with more than 162,000 deaths.
Brazil is also helping to test the Oxford vaccine and another promising candidate developed by US pharmaceutical giant Pfizer and Germany’s BioNTech.
Pfizer said Monday that its vaccine had shown 90 percent effectiveness, sparking a wave of optimism around the world that the end of the pandemic might be within reach.
The state of Sao Paulo has an agreement with Sinovac to buy 46 million doses of CoronaVac: six million produced in China and the rest produced in Sao Paulo, which started a factory last week to produce the vaccine in the country.
Bolsonaro blocked a plan by his health minister for the federal government to buy another 46 million doses.
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