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According to a police report, a study volunteer died by suicide, CNN confirmed on Tuesday, leading to a cause of death investigation and a pending toxicology report.
Brazil’s National Health Surveillance Agency (Anvisa) said on Wednesday that clinical trials of CoronaVac, developed by Chinese drug maker Sinovac, would be allowed to restart.
Phase 3 of the trials have been on hold since Monday, following what Anvisa described as a “serious adverse event” on October 29. A note from Anvisa says the trial has been suspended in order to better assess the data and assess the risk.
“After evaluating the new data presented by the sponsor after the suspension of the study, Anvisa concludes that there is sufficient benefit to allow the vaccination to resume and continues to follow the investigation into the outcome of the case. to define the possible causal relationship between the unexpected adverse event and the vaccine, ”Anvisa said in a statement Wednesday.
“It is important to clarify that a suspension does not necessarily mean that the product under investigation is not of quality, safety or efficacy,” he said.
Dimas Covas, director of the Brazilian Biomedical Institute Butantan, said the incident was unrelated to the vaccine trial itself. “The serious adverse event observed in a volunteer during the trial is unrelated to the vaccine,” Covas told reporters Tuesday at a press conference in Sao Paulo. “It was analyzed and determined that there was no relationship.”
In a statement posted online Tuesday, Sinovac said he was “confident in the safety of the vaccine.”
“We communicated with our Brazilian partner, the Butantan Institute, and the head of the institute believes that the incident has nothing to do with the vaccine. Sinovac will continue to communicate with the Brazilian side on this matter. Work related to our clinical research in Brazil will continue to be carried out in strict accordance with GCP (Good Clinical Practice) requirements, ”the statement said.
Sinovac began phase 3 clinical trials of its CoronaVac vaccine in collaboration with the Butantan Institute and the State of Sao Paulo at the end of July, with the aim of recruiting 130,000 volunteers.
Phase 3 trials represent the final and most important step in testing before regulatory approval is sought.
Sinovac is also conducting phase 3 trials in Indonesia and Turkey. Sinovac did not immediately respond to CNN’s request for comment.
CNN’s Tatiana Arias, Shasta Darlington, Nectar Gann and Ivana Kottasová contributed to this report.
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