Covaxin vaccine clinical studies canceled in Brazil
Anvisa reported the shot had not been administered in the country
Published in 27/07/2021 - 11:14 By Wellton Máximo - Brasília
Brazil’s national sanitary regulator Anvisa definitively canceled the clinical studies on Indian vaccine Covaxin in Brazil. In a note released last night (Jul. 26), the agency said the measure was taken after Precisa stopped representing the vaccine in the country.
“The decision was made after a technical assessment concluding that the end of Precisa’s authorization to represent the vaccine makes fulfilling the requirements for the clinical trials in the country impossible,” Anvisa declared in the statement.
Last Friday (23), Anvisa’s Coordination for Clinical Research had determined the precautionary suspension of clinical trials of Covaxin in the country. On the occasion, the agency relaid the decision to the Albert Einstein Institute and Precisa, which sponsored the tests.
The precautionary suspension took place only after Indian Company Bharat Biotech Limited International, the manufacturer of Covaxin, informed Anvisa that Precisa was no longer allowed to represent the firm in Brazil.
According to Anvisa, Covaxin was not administered in Brazilian volunteers.
Translation: Fabrício Ferreira - Edition: Aline Leal / Nira Foster