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Brazilian health officials have suspended a Phase 3 clinical trial involving a Chinese coronavirus vaccine citing a serious adverse event. The trial, which involved Chinese vaccine candidate Sinovac, named CoronaVac, had resulted in one death, but the death that occurred was unrelated to the vaccine, Reuters reported.
It was not clear whether the adverse event, which occurred on October 29, involved a trial participant in Brazil or another country currently testing the vaccine, and what the patient’s current condition was. Brazilian health authority Anvisa has not indicated when or if the trials will resume.
“After communicating with the Brazilian partner Butantan Institute, we learned that the director of the Butantan Institute believes that this serious adverse event was unrelated to the vaccine,” said a press release posted on the Sinovac website. “Sinovac will continue to communicate with Brazil on this matter. The clinical study in Brazil is strictly conducted in accordance with the requirements of Good Clinical Practice (Good Clinical Practice) and we are confident in the safety of the vaccine. “
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A statement regarding the suspension of the trial was posted on Anvisa’s website on Monday. He said clinical research on volunteers participating in the trial would be kept confidential. In addition to the death, the health agency has listed other possible events that could interrupt a trial such as a potentially fatal adverse event, persistent or significant disability, hospitalization, birth defect, or birth defect, suspected of transmission of an infectious agent, or an event.
The Butantan Institute, run by the state of Sao Paulo, which would produce the vaccine once approved, said it was surprised to learn that the trial had been halted and had not been informed by Anvisa officials, but then learned of the decision through the media.
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“We found this decision by Anvisa strange, because it has nothing to do with the vaccine,” said Dimas Covas, head of Butantan, referring to the death. “There are over 10,000 volunteers right now.”
The CoronaVac vaccine has sparked controversy in Brazil, with President Jair Bolsanaro only publicly rejecting it so that the Minister of Health would agree to purchase doses that would be produced locally, in an area ruled by Bolsanaro’s political enemy, the Governor Joao Doria. The row over whether to trust China on the vaccine spilled over to social media, where Bolsonaro continued to voice his opposition.
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“Death, disability, anomaly,” Bolsonaro posted on his Facebook page. “This is the vaccine Doria wanted to force everyone in Sao Paulo to take. The president said the vaccine should never be compulsory. Another that Jair Bolsonaro wins.
About 120,000 doses are expected to arrive in Sao Paulo later this month, and the equipment to produce about 40 million doses is also expected to arrive within weeks.
The Associated Press and Reuters contributed to this report.
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