June 29, 21 - 9:56 am - Reuters

Brazil’s health regulator terminates emergency use of CanSino’s Covid-19 vaccine

Brazil‘s health regulator Anvisa announced late Monday that it has decided to terminate the process that requested authorization for emergency use in Brazil of the Chinese laboratory CanSino‘s COVID-19 vaccine, after being notified by the laboratory of the end of the representation agreement with the Brazilian companies that made the request.

In a statement, Anvisa said the decision was made unanimously by its collegiate board after CanSino informed the agency in an e-mail sent on June 17 that the companies Belcher Farmacêutica do Brasil and Instituto Vital Brazil no longer had the authorization to represent it in the country.

“The loss of procedural legitimacy of the company Belcher Farmacêutica do Brasil Ltda and Instituto Vital Brazil S.A. to act before the agency by authorization of the company CanSino Biologics Inc. gives rise to the absence of conditions for maintaining the continuity of the evaluation of the request for authorization for emergency use of the vaccine Convidencia before Anvisa,” the regulatory agency said in a statement.

“It is important to inform that the manufacturer (CanSinoBio) requested substitution of the national representative, however, such action does not appear to be an administratively viable alternative. On the other hand, the new representative of the manufacturing company may file an AUE (emergency use authorization) request at any time.”

(Translated by LABS)