A year and a half after the approval of the emergency use, the National Health Surveillance Agency (Anvisa) received the application for the definitive registration of the CoronaVac vaccine against covid-19. The request was sent by the Butantan Institute yesterday (8), but the information was only released today (9) by the agency.
The immunizer has been approved in Brazil since January 17, 2021, for adults and children and adolescents aged 6 to 17 years. The authorization, however, provides for emergency use only.
Anvisa’s technical areas will analyze the final registration within 60 days. As with the other vaccines against covid-19, the request will have priority analysis, as signed by the Ministry of Health. Resolution of the Collegiate Board (RDC) 415/2020. In addition to the accelerated procedure, the rule provides for the possibility of signing terms of commitment.
The analysis will be carried out jointly by three different areas of Anvisa: the Medicines area, which evaluates safety and efficacy aspects; the Pharmacovigilance area, responsible for vaccine monitoring and follow-up plans; and by the Inspection and Inspection area, responsible for evaluating good manufacturing practices.
This is not CoronaVac’s only pending issue at Anvisa. Next Wednesday (13), the agency will discuss authorization for emergency use of the immunizer in children aged 3 to 5 years. The meeting will be held via videoconference and will be broadcast on Anvisa’s official YouTube channel.
