Brazil won’t conduct Sputnik V clinical trials - regulator

Society & Culture May 21, 2021, 6:03

The decision is not linked to the application to obtain emergency use authorization in the emergency situation because these processes are considered separately, the Brazilian Health Regulatory Agency said

RIO DE JANEIRO, May 21. /TASS/. Brazil’s Uniao Quimica pharmaceutical company who launched production of the Russian Sputnik V COVID-19 vaccine in the country has chosen to not conduct national clinical trials of the jab, the Brazilian Health Regulatory Agency (Anvisa) which issues relevant permits reported on Thursday.

Initially, clinical trials were set as a mandatory condition to secure vaccine authorization but was later waivered by the agency. "The decision relates exclusively to conducting clinical trials in Brazil and is not linked to the application to obtain emergency use authorization in the emergency situation because these processes are considered separately," the Anvisa press release reads.

On Thursday, the Sputnik V developer reported that the first commercial batch of its shot had been produced at a Uniao Quimica factory. The shipments produced in Brazil are expected to first go through quality control in the Gamaleya Center and later be exported to other Latin American countries.

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