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Brazil health regulator finally gives green signal to Covaxin imports

Brazil’s health regulator Anvisa (Agência Nacional de Vigilância Sanitária) has finally given the green signal for the exceptional import of Bharat Biotech’s indigenously developed Covid-19 vaccine.
The approval for the “distribution and use under controlled condition” of Covaxin has been granted only for 4 million doses initially and that too under specific conditions, said a loosely translated version of Anvisa’s announcement.
“After using the 4 million authorized doses, the agency will analyse the data for monitoring the use of the vaccine in order to assess the next quantities to be imported,” the Anvisa website said.
Brazil’s health ministry had placed an order for the import of 20 million doses of Covaxin.

“For the partial authorization, Anvisa considered the pandemic scenario in Brazil, the adjustments and new data presented in the new import order, as well as the information gaps that still exist in the analysis of Covaxin’s data and the mitigation actions proposed by the technical areas,” Anvisa said.

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