Brazil’s health regulator scraps Bharat Biotech’s EUA application of Covaxin

The move comes after Anvisa was informed by Bharat Biotech that it’s Brazilian partner-Necessidade no longer has authorization to represent them in Brazil.

Brazil’s health regulator, ANVISA has scrapped Bharat Biotech’s application seeking emergency use authorisation (EUA) of Covaxin.

“The Collegiate Board of the National Health Surveillance Agency unanimously decided to close the process that dealt with the temporary authorization of emergency use, on an experimental basis, of the Covaxin vaccine,” it said in a statement.

It said that the process will be closed without evaluating the merits of the request for temporary authorization for emergency use, on an experimental basis, filed by the company Necessidade Comercialização de Medicamentos Ltda. on June 29 this year.

The move comes after Anvisa was informed by Bharat Biotech that it’s Brazilian partner-Necessidade no longer has authorization to represent them in Brazil.

Director Meiruze Freitas, rapporteur of the process, highlighted that “the disruption of the commercial relationship between the companies, as well as the decay of a fundamental requirement for the Authorization of Emergency Use, implies impediment to the maintenance and continuity of the evaluation of the request.

The directors thought that evaluating the application would imply a significant waste of the administration’s efforts and resources.

On Friday, Anvisa had suspended the clinical studies of the Covaxin vaccine in Brazil.

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