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The Brazilian health regulator has halted clinical trials of the potential coronavirus CoronaVac vaccine, citing a “serious adverse event”.
Opponents of President Jair Bolsonaro said Tuesday they fear the decision – published Monday evening on Anvisa’s website – is motivated not by science but by the leader’s political hostility towards the country and state involved in the production of the candidate vaccine.
The potential vaccine was developed by the Chinese biopharmaceutical company Sinovac and in Brazil it would be produced mainly by the state-owned Butantan Institute in São Paulo. About 10,000 volunteers are taking part in phase three testing in one of the countries most affected by COVID-19.
Sao Paulo state health authorities said in a press conference Tuesday that Anvisa sent a single email at 8:40 pm saying testing should be suspended. They also said the incident with one of the trial volunteers was unrelated to the evidence.
“This news that comes the way it came causes our surprise, insecurity and, in our case, indignation,” said Dimas Covas, the head of the Butantan Institute.
He said it was “impossible” that the volunteer incident had any bearing on the tests.
Anvisa did not describe the October 29 event that resulted in the arrest. Covas told Culture TV on Monday that a volunteer had died, but on Tuesday he said he had just provided a hypothetical example and could not confirm details on the case for ethical reasons.
Sinovac released a brief statement in China on Tuesday stating that he was in contact with Brazilian authorities and insisted, “The clinical trial in Brazil is strictly conducted in accordance with GCP requirements and we are confident in the safety of the vaccine,” referring to Good Clinical. Practice, a set of international standards for ethics and data quality in clinical research.
Temporary interruptions of drug and vaccine testing are relatively common. In research involving thousands of participants, some are likely to get sick. Stopping a study allows researchers to investigate whether a disease is a side effect or a coincidence. Last month, two drug makers resumed testing their potential coronavirus vaccines in the United States after they were previously discontinued.
Sao Paulo health authorities said they had a meeting with Anvisa leaders early Tuesday, but have not received feedback on when the tests will be allowed to continue.
“This is unfortunate news; it worries all the volunteers who signed up to take the photo, “Covas said.” This could raise doubts among those who still intend to volunteer. “
The CoronaVac coup has already sparked controversy in Brazil, where President Bolsonaro has questioned its potential effectiveness. He publicly rejected it last month, saying Brazilians would not be used as guinea pigs. The statement followed news that his health minister, Eduardo Pazuello, had agreed to purchase Butantan’s locally produced doses of CoronaVac.
Bolsonaro has often expressed distrust of China, particularly during the election campaign in 2018, although he has somewhat softened his rhetoric in office. And the governor of the state that produces the vaccine, São Paulo. Joao Doria, is a political rival and an outspoken critic of the president’s pandemic response.
Bolsonaro took another shot at Sinovac’s shot on Tuesday.
“Death, disability, anomaly. This is the vaccine that Doria wanted to force everyone to take in São Paulo, ”he wrote on his Facebook page. “The president said the vaccine should never be mandatory. Another one won by Jair Bolsonaro “.
Joao Gabbardo, executive secretary of the COVID-19 committee of São Paulo and until months ago number 2 of the Brazilian Ministry of Health, criticized Bolsonaro’s statement without mentioning it.
“What upsets us is that while everyone is hurrying, doing everything possible to have this vaccine available to the population, some people are betting on the contrary, coincidentally the same day when the government of Sao Paulo announces the arrival of the first doses of the vaccine, “he said.
“Some people celebrate the fact that a death has appeared to create this mess and try to denigrate a vaccine that is being produced in this partnership with the Chinese laboratory. It is very sad to have to answer in this way. “
Former president Fernando Henrique Cardoso, one of the leaders of Governor Doria’s center-right party, said Anvisa’s decision didn’t seem scientific.
“What is happening is deplorable; the politization of the vaccine that will free us from the coronavirus … ”, Cardoso said on Twitter. “Anvisa needs to explain. It’s fast. “
CoronaVac is being tested in seven Brazilian states, in addition to the federal district where the capital Brasilia is located.
Following last month’s scam around the CoronaVac coup, Anvisa has authorized the import of 6 million doses from China. The potential vaccine cannot be given to Brazilians as it is not yet locally approved, the agency said at the time.
On Monday, Sao Paulo state health secretary Jean Gorinchteyn said the first 120,000 CoronaVac rounds would arrive at Sao Paulo International Airport on November 20, although he said, “They will only be brought to the public. after a final authorization from the Brazilian health authority.. “
The secretary added that nearly all of the volunteers who were given two doses of the vaccine produced antibodies thought to protect people from the virus.
Sao Paulo is also importing raw materials to produce 40 million CoronaVac rounds, which are expected to start arriving on November 27.
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Associated Press writer Huizhong Wu from Taipei, Taiwan contributed to this story.
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