- BBC World News
Brazilian health authorities gave the green light again on Wednesday to the trial of a Chinese vaccine against the coronavirus, which had been suspended two days earlier after a “serious adverse incident.”
The National Health Surveillance Agency (Anvisa) reported that it had “sufficient information to allow vaccination to resume”, after verifying that the death of a volunteer that led to the suspension “had no connection to the vaccine.”
“It is important to clarify that a suspension does not necessarily mean that the product under investigation does not offer quality, safety or efficacy,” Anvisa said in a statement.
President Jair Bolsonaro had described as “victoria“the suspension of the trial.
The president has long criticized the vaccine because of its ties to China and said his country would not buy it.
He has also been involved in a political fight with the governor of São Paulo, João Doria, who has publicly endorsed the trial.
Bolsonaro did not immediately comment on Anvisa’s announcement that the trial may resume.
Why was the trial stopped?
On Monday, Anvisa said it had “ruled to interrupt the clinical trial of the vaccine CoronaVac after a serious adverse incident “.
He did not reveal what had happened or where, but Dimas Covas, director of the Butantan Institute that conducts the trials, told local media that the suspension was related to the death of a volunteer.
His version was supported by the Secretary of Health of the state of São Paulo, Jean Gorinchteyn, who told a press conference that the death was a “external event“That was not related to the vaccine.
Brazilian media indicate that the police are investigating the death as a suicide.
Covas clarified that no adverse reactions to the vaccine had been reported and that the decision to suspend the trial had caused “outrage.”
The Chinese vaccine
The vaccine, developed by the Chinese firm Sinovac Biotech, is one of several in the final phase of testing worldwide and the pharmaceutical company said after the suspension in Brazil that it “was confident in the safety” of the product.
Late-stage trials for the Sinovac vaccine are also underway in Indonesia and Turkey, but none of these countries has announced a suspension of them.
Brazil has been one of the countries most affected by the coronavirus with more 5.6 million confirmed cases and about 163,000 deaths, the third highest figure in the world after the United States and India, according to data compiled by Johns Hopkins University.
In its statement on Wednesday, Anvisa clarified that it now had more details about the nature of the “adverse incident” and that its decision to suspend the trial had “taken into consideration the data known to the agency at that time.”
A pause in a clinical trial is not unusual.
In September, the UK halted trials of another COVID-19 vaccine after a participant had a suspected adverse reaction.
Trials of the vaccine being developed by AstraZeneca and the University of Oxford resumed a few days later, after regulators said it was safe to continue.
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