Hyderabad: Brazilian health regulator Anvisa has approved the exceptional import of Bharat Biotech’s Covaxin into the country in Hyderabad. The agency had earlier refused permission to import the vaccine, citing certain breaches of good manufacturing practice (GMP) at the factory.
Brazil is initially expected to receive four million doses of Covaxin. After using the authorized doses, the agency will analyze the data for monitoring the use of the vaccine to determine the next amounts to be imported, Anvisa said.
According to the conditions set by Anvisa, all the vaccines for Brazil must be manufactured after the adaptation of GMP implemented by Bharat Biotech, according to the report on corrective and preventive actions submitted to the health regulator.
In February, Bharat Biotech announced that it had signed an agreement with the Brazilian government for the supply of 20 million doses of Covaxin during the second and third quarters of 2021.
Anvisa also approved a proposal to import the Russian Sputnik V vaccine. Brazil has become the 67th country in the world to authorize Sputnik V.
The authorization for the import and use of the vaccine by Brazil was accepted after analyzing a technical report sent to Anvisa by the Ministry of Health of the Russian Federation. In addition, the Russian side has previously provided the regulator with additional data confirming the absence of recurrent adenoviral vectors.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: “Anvisa’s decision to approve the use of the Sputnik V vaccine in several Brazilian states will provide access to one of the best drugs against coronavirus in the world. “
Source: Telangana Today