Hyderabad: Brazilian health regulator Anvisa has approved the exceptional import of Hyderabad-based Bharat Biotech’s Covaxin into the country. The agency earlier denied permission to import the vaccine citing certain violations of good manufacturing practices (GMP) at its facility.
Brazil is expected to receive four million doses of Covaxin initially. After using the authorised doses, the agency will analyse the data for monitoring the use of the vaccine in order to assess the next quantities to be imported, Anvisa said.
As per the conditions Anvisa has set, all the vaccine consignments for Brazil must have been manufactured after the adaptation of GMP implemented by Bharat Biotech, according to the corrective and preventive action report presented to the health regulator.
In February, Bharat Biotech had said it signed an agreement with the Brazilian government for the supply of 20 million doses of Covaxin during the second and third quarters of 2021.Sputnik approved
Anvisa also approved a proposal to import Russia’s Sputnik V vaccine. Brazil has become the 67th country in the world to authorise Sputnik V.
The authorisation for import and use of the vaccine by Brazil was accepted after analysis of 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 replicating 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 open access to one of the best drugs against coronavirus in the world.”
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