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Wednesday, November 11, 2020

Brazil's health regulator allows resumption of Chinese vaccine trial

Brazil’s health regulator Anvisa announced on Wednesday the resumption of clinical Phase III trials for China’s Sinovac COVID-19 vaccine.

Anvisa on Monday suspended the trials of the Sinovac SVA.O vaccine after the death of a volunteer that was registered as a suicide.

The regulator said that it had not been informed of the cause of the volunteers’ death when it took the decision and was only provided with the details the following day by the Butantan biomedical center which is running the trials.

“After evaluating the new data presented by the sponsor... Anvisa understands that it has sufficient reasons to allow the resumption of vaccination,” the agency’s statement said.

“It is important to clarify that a suspension does not necessarily mean that the product under investigation does not offer quality, safety or efficacy,” Anvisa said.

https://www.reuters.com/article/us-health-coronavirus-brazil-sinovac/brazils-health-regulator-allows-resumption-of-chinese-vaccine-trial-idUSKBN27R249

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