Brazil’s National Health Surveillance Agency (Anvisa) has concluded its first day of inspections at Chinese pharmaceutical giant Sinovac Biotech’s coronavirus vaccine production facility.
The first step of the process is to check Sinovac’s quality control systems, as well as risk and data management processes, and the validation master plan.
Sinovac is producing the CoronaVac, a potential vaccine being tested in Brazil by the São Paulo state government. Observers fear that regulatory processes could be contaminated by political disputes between São Paulo Governor João Doria and President Jair Bolsonaro — under whom Anvisa operates.
The president has challenged the safety of the CoronaVac on multiple occasions, and went as far as celebrating the suicide of a volunteer that led to the temporary suspension of clinical trials of the Chinese-made vaccine earlier in November.
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