www.fdanews.com/articles/199968-brazils-health-regulator-halts-coronavac-covid-19-trial
Brazil’s Health Regulator Halts CoronaVac COVID-19 Trial
November 11, 2020
Brazilian health regulator ANVISA (Agência Nacional de Vigilância Sanitária) has stopped a phase 3 trial evaluating Chinese drugmaker Sinovac’s COVID-19 vaccine candidate.
The decision to suspend the CoronaVac trial followed a reported serious adverse event that occurred on Oct. 29. ANVISA said it is reviewing the available data and assessing the risks and benefits of restarting the trial.
According to Sinovac, Brazil’s Butantan Institute, which is leading the trial, does not believe the adverse event is related to the vaccine.