The National Health Surveillance Agency (Anvisa) confirmed that it had received the definitive registration request from Coronavac, which was sent by the Butantan Institute on Friday (8). The agency period for analysis is 60 days.
The vaccine has been approved in Brazil since January 17, 2021, for children and adolescents aged 6 to 17 years, in addition to adults, but only for emergency use. The application will be evaluated by the technical areas of the agency.
Coronavac, like the other vaccines against Covid-19 that are already authorized in Brazil, may undergo priority analysis, according to Collegiate Board Resolution (RDC) 415/2020, which contains extraordinary criteria and procedures for registration requests related to to the fight against the coronavirus.
The application will be evaluated by the technical areas of the agency. According to Anvisa, the analysis is carried out by the Medicines areas, which assess safety and efficacy aspects; Pharmacovigilance, responsible for the monitoring and follow-up plans of the vaccine after its entry into use in the country; and Inspection and Inspection, responsible for evaluating Good Manufacturing Practices.
Next Wednesday (13), Anvisa will discuss the authorization of emergency use of the Coronavac vaccine against Covid-19 for children from 3 to 5 years old. The meeting takes place at 2:30 pm. Coronavac is already used in children and adolescents in different countries, including China, Hong Kong, Chile, Ecuador, Colombia, Thailand and Cambodia.
*Posted by Marcelo Tuvuca
Source: CNN Brasil
