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Sunday, January 10, 2021

Brazilian Authorities Allow Resumption of China COVID-19 Vaccine Trial

Brazil health regulator Anvisa announced on Thursday morning it has officially allowed the resumption of late-stage Brazilian clinical trials for China’s Sinovac COVID-19 vaccine, which had been suspended after a study subject’s death.

Brazil health regulator Anvisa announced on Thursday morning it has officially allowed the resumption of late-stage Brazilian clinical trials for China’s Sinovac COVID-19 vaccine, which had been suspended after a study subject’s death.

In a statement, Anvisa said that the initial information it received about the case, which led to the suspension, had been incomplete and lacked the cause of the “severe adverse event”. It also suggestions the decision could have been politically motivated.

“After evaluating the new data presented by the sponsor … Anvisa understands that it has sufficient reasons to allow the resumption of vaccination,” the agency explained in its statement.

“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 pointed out.

In a separate statement, Sinovac said “We are confident in the safety of the vaccine, fully understand and appreciate Anvisa’s strict supervision and timely resumption of the clinical studies.”

Brazil has one of the world’s worst COVID-19 outbreaks, with over 5.7 million confirmed cases and 163,000 deaths.

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