BRIEF—Brazilian regulator grants approval for Covaxin and Sputnik V

7 June 2021

Brazil has given clearance to the proposal to import Indian drugmaker Bharat Biotech's COVID-19 vaccine Covaxin into the South American country with some conditions, according to India Today.

The National Health Surveillance Agency of Brazil (ANSIVA) had earlier denied permission to import Covaxin after authorities found that the Indian plant in which the jab was being made did not meet the good manufacturing practice (GMP) requirements.

According to the ANSIVA's approval, Brazil is expected to receive four million doses of Covaxin initially.

The Brazilian health regulator also approved another proposal to import Russia's Sputnik V vaccine by several states of the country, the Russian Direct Investment Fund (RDIF) announced on Saturday.

Sputnik V was authorized for import and use by Brazilian states after the ANVISA considered the technical report provided by Russia’s Health Ministry. Additional data has been provided to the ANVISA by the Russian side confirming that replication-competent adenoviral vectors (RCA) had not been detected. Also, real-life data obtained in a number of countries using Sputnik V confirms vaccine’s high efficacy and safety.

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