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SAO PAULO – The Brazilian health regulator has stopped clinical trials of the potential coronavirus vaccine CoronaVac, citing a “serious adverse event”.
The decision published on Anvisa’s website on Monday evening aroused immediate surprise from the parties involved in the production of the 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. The government of the State of Sao Paulo stated in a statement that it “regrets having been informed by the press and not directly by Anvisa, as is normally the case in clinical trials of this type”.
Butantan said in a statement that he was surprised by Anvisa’s decision and would be holding a press conference on Tuesday.
Sinovac released a brief statement in China on Tuesday stating he was in contact with Brazilian authorities. “Sinovac will continue to communicate with Brazil on this topic. The clinical study in Brazil is strictly conducted in accordance with GCP requirements and we are confident in the safety of the vaccine,” he said, referring to Good Clinical Practice, a set of international standards for ethics and data quality in clinical research.
He did not provide further details.
The CoronaVac coup has already sparked controversy in Brazil, where President Jair Bolsonaro has questioned its potential effectiveness. It sparked confusion last month when he publicly rejected it, 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. Additionally, Sao Paulo state governor Jo├úo Doria has become a political rival and outspoken critic of the president’s pandemic response.
Anvisa said in her statement that the event that led to the suspension of the trial took place on October 29, without saying what happened.
“With the discontinuation of the study, no new volunteers can be vaccinated,” says his statement.
Dimas Covas, who leads Butantan, told Culture TV on Monday that a volunteer had died, but that the person’s death was not due to the shot.
“We found this decision by Anvisa strange, because it is not related to the vaccine. There are more than 10,000 volunteers right now,” he said.
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.
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.
“We will continue to follow the health protocols to give the shots. They will be brought to the public only after a final authorization from the Brazilian health authority,” Gorinchteyn said.
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 for the production of 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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