Deck cleared for import of COVAXIN, Sputnik V into Brazil
(Sourced from PTI)
Brazil has cleared the proposal to import Bharat Biotech's COVID-19 vaccine, COVAXIN, and Russia's COVID-19 vaccine Sputnik V into the South American country. The National Health Surveillance Agency of Brazil, ANVISA, 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 ANVISA's approval, Brazil is expected to receive four million doses of COVAXIN initially. After using the authorized doses, the agency will analyze the data for monitoring the use of the vaccine to assess the next quantities to be imported.
ANVISA said in a statement, "This Friday, ANVISA authorized the exceptional import of the COVAXIN by the Ministry of Health, for distribution and use under controlled conditions." "The authorization defined amount of four million doses, which can be used only under specific conditions. The decision was taken at the 9th Extraordinary Public Meeting of the Collegiate Board," it added.
"All vaccine batches to be destined for Brazil must have been manufactured after the adaptations of Good Manufacturing Practices (GMP) implemented by Bharat Biotech, according to the Corrective and Preventive Action (CAPA) report presented to ANVISA," the regulator said. On February 26, Bharat Biotech had said that it has signed an agreement with Brazil for supply of 20 million COVAXIN doses in 2021.
Meanwhile, announcing the approval of Sputnik V by Brazil on its official Twitter page, the Russian vaccine manufacturer said, "#SputnikV will be used in Brazil following ANVISA's approval. Brazil has become the 67th country in the world to authorize Sputnik V." "The Sputnik V team fully answered all questions from ANVISA on the vaccine's efficacy & safety," it added.