Anvisa receives request for the use of Coronavac in children aged 3 to 5 years

Anvisa receives request for the use of Coronavac in children aged 3 to 5 years

Anvisa (National Health Surveillance Agency) received a request from the Butantan Institute to expand the use of the Coronavac vaccine in children aged 3 to 5 years. The request was made this Friday (11).

The regulatory agency has already approved the immunizer for children and adolescents aged 6 to 17 years in January this year.

At the time, Anvisa vetoed the application of the vaccine to the public from 3 to 5 years old, understanding that there was not enough data to authorize the immunizer in this age group.

According to Anvisa, the evaluation period for this new request is up to seven working days and starts counting from Monday (14).

The agency also said that the technical analysis will be carried out rigorously and with all the necessary caution for this audience.

“In the case of vaccines for children, some of Anvisa’s main points of attention refer to safety data and identified adverse events, vaccine dosage adjustment, specific factors of the organisms of children in the development phase, among others”, said in a note.

The immunizer manufactured by Butantan has been authorized for emergency use in Brazil since January 17, 2021 for people aged 18 and over.

This is the third request made by the Butantan Institute to immunize children. The first, presented in July, was evaluated by the regulatory agency and denied because of limited data in the studies presented. The second approved the vaccine in children and adolescents aged 6 to 17 years.

On December 16, Anvisa authorized the use of the Pfizer vaccine to immunize children aged 5 to 11 years.

On January 5, the Ministry of Health announced that children would receive the vaccine without the need for a medical prescription.

The vaccination campaign was opened on January 14 in São Paulo. The first immunized was Davi Seremramiwe Xavante, an 8-year-old indigenous boy.

The vaccination of children and adolescents is a sensitive topic in the Jair Bolsonaro government (PL), which has distorted data and discouraged the immunization of young people. He even threatened to expose the names of Anvisa’s servers who approved the use of Pfizer vaccines in children.

The Ministry of Health acquired 10 million doses of Coronavac with the Butantan Institute to vaccinate children.

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