The National Health Surveillance Agency (Anvisa) announced this Friday morning (8) that it received the first request for the emergency use of a vaccine against covid-19 in Brazil: Coronavac, produced by the Chinese laboratory Sinovac in partnership with the Butantan Institute, São Paulo.
The online protocol with the request was delivered by Butantan shortly before the start of this Friday’s virtual meeting with the regulatory agency, at 9:34 am, according to the institute. Anvisa, which will have 10 calendar days to analyze the process, informed that it has already started sorting the documentation.
In a note, Anvisa clarified: “The first 24 hours will be used to screen the process and check if all the necessary documents are available. If there is important information missing, Anvisa can pause the deadline and request additional information from the laboratory”.
After Anvisa officially received the request for the emergency use of the vaccine, the governor of São Paulo, João Doria (PSDB) used his Twitter account to register that CoronaVac “proved its effectiveness and safety and will now be able to immunize millions of Brazilians”.
Anvisa clarified that the order analysis is performed by a multidisciplinary team made up of specialists in the areas of registration, monitoring and inspection. The final result of the study on efficacy is the last step necessary for Anvisa to analyze the request for authorization to start immunization in the Brazilian population.