The National Health Surveillance Agency (Anvisa) will discuss, next Wednesday (13), the authorization of emergency use of the Coronavac vaccine against Covid-19 for children from 3 to 5 years old.
The immunizer is already used in Brazil in children and adolescents from 6 to 17 years old, in addition to the adult public.
“On the agenda is the evaluation of the Emergency Use Authorization of the Coronavac vaccine for children aged 3 to 5 years. The directors’ meeting will be held via videoconference and can be followed live on the Agency’s YouTube channel”, informed Anvisa.
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.
Historic
On January 20, the National Health Surveillance Agency (Anvisa) authorized the use of the Coronavac vaccine against Covid-19 in children and adolescents from 6 to 17 years of age in Brazil.
The request made by Butantan covered the age group from 3 to 17 years old. However, Anvisa’s technical team indicated gaps in the effectiveness and safety studies for the population aged 3 to 5 years and immunosuppressed.
On March 11 of this year, Anvisa received a new request from the Butantan Institute to include the age group from 3 to 5 years in the Coronavac indication.
Evaluation
The director of the Brazilian Society of Immunizations (SBIm), Renato Kfouri, explains that Anvisa’s evaluation follows strict international criteria, including the analysis of the quality of the data presented in the expansion request.
According to him, the data available at that time on studies of Coronavac in the pediatric population aged 3 to 5 years were still limited. “The expectation of approval is not a function of age or who uses the vaccine in other countries, but the quality of the data that is presented to justify the registration”, he says.
*With information from Lucas Rocha, from CNN Brasil
Source: CNN Brasil
