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The National Health Surveillance Agency (Anvisa) published, this Monday, the certificate of good manufacturing practices from the Chinese laboratory Sinovac, developer of the potential vaccine against Covid-19 CoronaVacthe regulator said in a note.
Anvisa said it granted the certification after inspecting the Sinovac unit responsible for producing the vaccine in Beijing and after receiving information from the Butantan Institute, responsible for the clinical studies of the possible vaccine in Phase 3 in Brazil and that has already received the vaccine in bulk to be completed at its facilities in São Paulo.
“The complete stage is one of the prerequisites to continue both the Sinovac vaccine registration process and an eventual request for authorization for the emergency use of this vaccine that will be presented to Anvisa,” the agency said in a note .
After a series of frictions with Butantan involving CoronaVac, including a brief test hiatus in November, Anvisa noted in the note that it completed the certification 10 days ahead of schedule.
Butantan promises to announce on Wednesday the result of CoronaVac’s efficacy after Phase 3 tests and, on the same date, to request the definitive registration of the immunizing potential simultaneously from the Brazilian and Chinese regulatory agencies. It will also ask Anvisa for authorization for the emergency use of the vaccine.
