Butantan Institute requests definitive registration of CoronaVac

A year and a half after the approval of the emergency use of the CoronaVac vaccine against COVID-19, Brazil’s national drug regulator Anvisa received the application for its definitive registration. The request was sent by the Butantan Institute of São Paulo.

The immunizer had been approved in Brazil on January 17, 2021, for adults and children, and adolescents aged 6 to 17 years. The authorization, however, provides only its emergency use.

Anvisa’s technical areas will analyze the final registration within 60 days. As with other vaccines against COVID-19, the request will have priority analysis, according to Anvisa’s rule.

The analysis will be carried out jointly by three different areas: the Medicine sector, which evaluates safety and efficacy aspects; the Pharmacovigilance area, responsible for vaccine monitoring and follow-up plans; and the Inspection sector, in charge of assessing good manufacturing practices.

Next Wednesday (Jul. 13), Anvisa will discuss the authorization for emergency use of the CoronaVac immunizing agent in children aged 3 to 5 years.