Brazil’s national health regulator allowed clinical trials of a Chinese-developed COVID-19 vaccine to resume Wednesday, November 11, 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 on the nature of the “adverse incident” that led it to halt final-stage trials of the CoronaVac vaccine, and had “sufficient information to allow vaccination to resume.”
Public health officials had said the incident that led to the suspension – a volunteer recipient’s death, which police are investigating as a suicide – had no connection with 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 caught up in a messy political battle in Brazil, where its most visible backer has been Sao Paulo Governor Joao Doria, a leading Bolsonaro opponent.
The president has thrown his support behind another vaccine, developed by Oxford University in Britain and the British-Swedish pharmaceutical firm AstraZeneca.
Bolsonaro, who has railed against CoronaVac as “Joao Doria’s Chinese vaccine” and blocked the federal government from purchasing it, had claimed the regulatory decision as vindication.
“Chalk up another win for Jair Bolsonaro,” he wrote Tuesday on Facebook, referring to himself in the third person.
Bolsonaro faces criticism from experts for his handling of the pandemic, which has included playing down the virus, opposing lockdown measures, and relentlessly promoting the drug hydroxychloroquine despite studies showing it is ineffective against COVID-19.
Even as it reversed course, Anvisa defended its decision, which it said was purely “technical.”
It said the public health center coordinating the study in Brazil, the Butantan Institute in Sao Paulo, had not sent it the cause of death, independent safety review or a required incident report until Tuesday.
The decision “took into consideration the data known to the agency at the time,” it said.
Developed by Chinese pharmaceutical firm 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 around 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 people killed.
Brazil is also helping test the Oxford vaccine and another promising candidate developed by US pharmaceutical giant Pfizer and Germany’s BioNTech.
Pfizer said Monday its vaccine had shown 90% effectiveness, unleashing a surge of optimism worldwide that an end to the pandemic could be within reach.
Sao Paulo state has a deal with Sinovac to buy 46 million doses of CoronaVac – 6 million produced in China and the rest produced in Sao Paulo, which broke ground last week on a factory to make the vaccine domestically.
Bolsonaro blocked a plan by his health minister for the federal government to buy another 46 million doses. – Rappler.com