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Anvisa published on Monday (21) the Good Manufacturing Practices certification for the Coronavac vaccine factory.
The conclusion was made by the Anvisa team and the Butantan Institute observers who traveled to China to inspect the vaccine production of the Sinovac pharmaceutical company.
Anvisa certifies Sinovac for its good manufacturing practices
The group was in the country between November 30 and December 4 to carry out inspections and meetings with company executives.
According to the note published in the Official Gazette, the Butantan Institute sent the action plan to Anvisa on Wednesday (16). The conclusion of the technical team was completed last Sunday (20).
The authorization was published 10 days before the initial forecast established by the agency.
The certificate is valid for two years and is one of the prerequisites for both the vaccination registration process in Brazil and for an eventual request for authorization for emergency use.
Anvisa inspection team and Butantan observers on the left and Sinovac senior management on the right – Photo: Pearson / Anvisa
The Sinovac certification takes place on the same day that the Butantan Institute announced that the third and final phase of clinical trials of the CoronaVac vaccine, which it is developing in collaboration with the Chinese laboratory, has been completed.
Through social networks, Butantan also announced this Monday that “the results [da fase 3] it will be sent to the National Sanitary Surveillance Agency (Anvisa) ”, and that,“ soon, the first Brazilian vaccine against Covid-19 will be ready ”.
The institute’s forecast is to announce the results of phase 3 this Wednesday (23).
