Brazil authorized the proposal
to import Bharat Biotech’s COVID-19 vaccine, Covaxin, to the South American country.
Brazil’s National Health Surveillance Agency-Anvisa previously denied permission to import Covaxin after authorities discovered that the Indian factory where the jab was made did not meet good practice requirements. manufacturing (BPF).
Brazil’s health regulator has also approved another proposal to import Russia’s Sputnik V vaccine into that country.
According to Anvisa’s approval, Brazil is expected to initially receive four million doses of Covaxin.
After using the authorized doses, the agency will analyze the vaccine use monitoring data in order to assess the next quantities to be imported.
“Anvisa authorized this Friday the exceptional importation of the Covaxin vaccine by the Ministry of Health, for distribution and use under controlled conditions.
The authorization defined an amount of 4 million doses, which can only be used under specific conditions (…) the decision was taken during the 9th extraordinary public meeting of the collegiate council, “he said. stated in a statement in Portuguese.
All batches intended for Brazil must have been manufactured after the adaptations of Good Manufacturing Practices (GMP) implemented by the manufacturer, Bharat Biotech, according to the corrective and preventive action report (Corrective and Preventive Action – CAPA) presented to Anvisa, the regulator said.
On February 26, Bharat Biotech Ltd 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.
Announcing Brazil’s approval of Spuknik V on its official twitter page, the Russian vaccine maker said: “#SputnikV will be used in Brazil following ANVISA approval. Brazil became the 67th country in the world to allow Spuknik V.
The Sputnik V team answered all of ANVISA’s questions about the efficacy and safety of the vaccine.
(Only the title and image of this report may have been reworked by Business Standard staff; the rest of the content is automatically generated from a syndicated feed.)