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Brazil’s health regulator said it had suspended clinical trials of a Covid-19 vaccine developed in China after an “adverse incident” involving a volunteer recipient, a blow to one of the most advanced candidate vaccines.
The setback for CoronaVac, developed by China’s Sinovac Biotech, came on Monday when US pharmaceutical giant Pfizer said its own vaccine candidate had shown 90 percent effectiveness, sending global markets skyrocketing and raising hopes. for the pandemic to end.
Sinovac Biotech supported its creation on Tuesday, saying: “We are confident in the safety of the vaccine.”
Brazilian regulator Anvisa said it had “ruled to discontinue the clinical study of the CoronaVac vaccine after a serious adverse incident” involving a volunteer recipient on October 29.
He said that he could not elaborate on what happened due to privacy regulations, but that such incidents included death, potentially fatal side effects, serious disability, hospitalization, birth defects and other “clinically significant events.”
However, Sinovac said the incident “was not related to the vaccine,” adding that it “will continue to communicate with Brazil on this matter.”
The public health center that coordinates the trials of the vaccine in Brazil, the Butantan Institute, said it was “surprised” by Anvisa’s decision.
The institute “is investigating what happened in detail” and “is at the disposal of the Brazilian regulatory agency to provide any necessary clarification on any adverse incident that clinical trials may have presented,” he said.
CoronaVac has been embroiled in a disorderly political battle in Brazil, where its most visible backer has been Sao Paulo Governor Joao Doria, a senior opponent of far-right President Jair Bolsonaro.
The São Paulo state government said in a statement that it “regrets having learned of the decision from the press, rather than directly from Anvisa,” and was waiting together with the Butantan Institute for more information on “the true reasons for the suspension. “.
– Pandemic policy –
Bolsonaro has labeled CoronaVac as the vaccine from “that other country” and instead has pushed for a rival vaccine developed by the University of Oxford and the pharmaceutical company AstraZeneca.
Last month, he rejected a plan by his own health minister to buy 46 million doses of CoronaVac, saying, “The Brazilian people will not be anyone’s guinea pig” and referring to it as “Joao Doria’s Chinese vaccine.” .
Doria announced early Monday that the first 120,000 doses of CoronaVac would arrive in Sao Paulo on November 20.
His state has an agreement with Sinovac to buy a total of 46 million doses, six million produced in China and the rest produced in Sao Paulo, which began last week at a factory to manufacture the vaccine in the country.
“State government officials fear that Bolsonaro will use technical decisions to delay the vaccine schedule for political reasons,” newspaper Folha de Sao Paulo reported, citing anonymous allies of Doria.
Anvisa told AFP it had no comment beyond its statement announcing the stay, which said stopping the trials was standard procedure in such cases.
Bolsonaro faces criticism for his handling of the pandemic, which has included downplaying the virus, opposing lockdown measures and relentlessly promoting the drug hydroxychloroquine despite studies showing it to be ineffective against Covid-19.
All are being tested in Brazil, the country with the second highest death toll in the pandemic after the United States, with more than 162,000 deaths from the new coronavirus.
jhb-tjx / rox / fox
