Anvisa (National Health Surveillance Agency) received a new request from the Butantan Institute so that Coronavac can be used in children and adolescents from 3 to 17 years old.
Anvisa’s evaluation period for this new order is up to 30 days.
To include new audiences in the package insert for immunizing against Covid, the laboratory needs to conduct studies that demonstrate the safety and efficacy relationship for a given age group. These studies can be conducted in Brazil or in other countries.
“We had the information that Coronavac filed a request today. During our meeting, we were alerted by the technical areas that Coronavac filed with the request for analysis,” said the CEO of Anvisa, Antonio Barra Torres, in public hearing in the Chamber of Deputies this Wednesday (15).
The governor of São Paulo, João Doria, also confirmed that the Butantan Institute made a new official request to Anvisa. He recalled that some countries are already vaccinating with the immunizing agent in this age group and hopes that the decision comes out before the New Year.
A week ago, Doria announced the reservation of 12 million doses of Coronavac for the vaccination of children. The goal in São Paulo is to start the application of Coronavac in children under 18 years old immediately after an eventual positive communication from Anvisa regarding the new order from Butantan.
This is the laboratory’s second request to indicate the immunizing agent for this age group.
The first request presented in July was evaluated by Anvisa and denied because of the limited data of the studies presented at that time.
The regulatory agency said, in a decision taken on August 18, that it lacked information to prove the efficiency and safety of Coronavac for this group.
Developed by the Chinese laboratory Sinovac and produced in Brazil by the Butantan Institute, Coronavac has been authorized for emergency use in Brazil since January 17 this year for persons over 18 years of age.
For now, in Brazil, Pfizer is the only vaccine authorized by Anvisa for children under 18, and only for those aged between 12 and 17.
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