The clinical trial of the COVID-19 vaccine in Brazil which was developed by China’s Sinovac Biotech came to a pause on Tuesday after Brazilian health authority intervened in the trial for a clinically significant event.
The frontrunner vaccine called CoronaVac is developed by the Chinese pharma giant and was being trialed by Brazil for potential mass orders for its citizens once approved.
Sinovac has maintained that they are confident over the safety of the vaccine, and the Brazilian watchdog which regulated developments of such vaccines refused to comment beyond specifying the trial was paused.
In a statement, Sinovac claimed the adverse incident has nothing to do with the vaccine and the company will continue talks with Brazil over this matter.
The Brazilian regulator Anvisa said it had “ruled to interrupt the clinical study of the CoronaVac vaccine after a serious adverse incident” came to light involving a volunteer recipient on October 29, France 24 reported.
The setback of the Chinese vaccine comes a day after US-based Pfizer and partner Germany-based BioNTech reported over 90% efficacy of their COVID-19 vaccine in large-scale clinical trials — the first such claim in the world from any Coronavirus vaccine under development so far.
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Meanwhile, Russia’s COVID-19 vaccine called Sputnik V which stirred controversy for trespassing traditional regulatory approval processes has also claimed it inhabits the disease by 90% hours after Pfizer made their announcement.
On November 20, 120,000 doses of CoronaVac is scheduled to arrive at Sao Paolo, Dimas Covas, director of the Butantan Institute said. Up to 6 million doses are set to enter Brazil by December once Anvisa approves the same.
Anvisa gave no detailed revelation about what exactly the adverse side-effect was citing privacy regulations, but said these could include death, serious disability, potentially fatal side-effect, hospitalization, and birth defect, the report said.
It must be noted, clinical trials of CoronaVac has met with a messy reception from Brazil’s political landscape.
The Chinese vaccine trial in the nation does not bode well with far-right President Jaire Bolsanaro, who has pressed for another competing vaccine by AstraZeneca and Oxford University.
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The Brazilian President has reportedly shot down proposals from his own health minister to procure some 46 million doses of Sinovac’s COVID-19 vaccine, saying: “The Brazilian people will not be anyone’s guinea pig,” and referring to it as “Joao Doria’s Chinese vaccine.”
And the main supporter of CoronaVac is the Sao Paulo Governor Joao Doria, who’s a top opponent of President Jair Bolsonaro.
The Butantan Institute, which oversees the novel coronavirus vaccine development in Brazil along with Anvisa has said it is investigating what has happened and is ready to co-ordinate and advise Anvisa over any adverse incident that has happened.
President Bolsonaro faces strong criticism for his handling of the pandemic in Brazil, which has the second-highest death-rate from the novel coronavirus in the world, and third-hight caseload.