This case happened after the manufacturer informed that Belcher Pharmaceuticals and Instituto Vital Brazil no longer have authorization to represent the company in the country
The National Health Surveillance Agency (Anvisa) completed the authorization process for the emergency use of the Convidecia vaccine against Covid-19. The immunizing agent is made by the Chinese laboratory Cansino Biologics Inc and, in Brazil, it was represented by Belcher Farmacêutica and Instituto Vital Brazil. However, on June 17, the manufacturer stated that companies no longer have authorization to represent the institution in the country. “The statement sent to Anvisa informs of the revocation of the authorization granted and highlights that the companies Belcher Farmacêutica do Brasil Ltda and Instituto Vital Brazil SA do not have authorization to apply for Emergency Use Authorization, Registration, Marketing Authorization as well as preparation and distribution activities of the vaccine.”
Therefore, given the “misalignment between the holder and the developer and manufacturer of the CanSino vaccine, intrinsic and essential mechanisms of technical supervision were compromised”, informed Anvisa, closing the authorization request. According to the regulatory agency, it is not possible to change representatives in the same authorization request process, but the manufacturer can make a new request for emergency use whenever desired. It is noteworthy that vaccine CanSino is in the sights of the members of the CPI to Covid-19.
*With information from the reporter Fernando Martins