A year and a half after the emergency use approval, Anvisa (National Health Surveillance Agency) received the application for final registration of the CoronaVac vaccine against Covid-19. The request was sent by the Institute of Butantan on Friday (8), but the information was released by the agency only this Saturday (9).

Anvisa receives application for final registration from CoronaVac – Photo: Marcelo Camargo/Agência Brasil/ND

The immunizer has been approved in Brazil since January 17, 2021 for adults, children and adolescents aged 6 to 17. However, the permit provides for use only in emergency cases.

Anvisa’s technical departments will review the final registration within 60 days. As with other covid-19 vaccines, the request will have priority review, as signed by Collegiate Council Regulation (RDC) 415/2020. In addition to the accelerated procedure, the rule provides for the possibility of signing the terms of the obligation.

The analysis will be carried out jointly by three different areas of Anvisa: the Medicines area, which assesses aspects of safety and efficacy; pharmacovigilance area responsible for vaccine monitoring and follow-up plans; and the inspection and inspection area responsible for evaluating good manufacturing practices.

This is not the only unresolved CoronaVac issue at Anvisa. Next Wednesday (13) the agency will discuss the emergency use authorization of the immunizer in children aged 3 to 5 years. The meeting will be held via videoconference and will be broadcast on the official Anvisa YouTube channel.