Butantan asks Anvisa to authorize the use of CoronaVac in children and adolescents from 3 to 17 years old – Prime Time Zone


Results of an early-stage study carried out by Chinese pharmaceutical Sinovac showed that the immunizing agent is safe and capable of creating antibodies against Covid-19 in people of this age group

ADRIANA TOFFETTI/A7 PRESS/ESTADÃO CONTENT – 12/12/2020In Brazil, the only vaccine approved for children under 18 is that of Pfizer

A National Health Surveillance Agency (Anvisa) received, this Friday, 30, a request from the Butantan Institute to expand the age range for vaccine indication CoronaVac, produced in partnership with Chinese pharmaceutical Sinovac. The intention is to include the audience of children and teenagers aged between three and 17 years in the package insert. vaccine. Since January 17, 2021, the immunizing agent is authorized for emergency use in Brazil, but only for people aged 18 or over. The request for expansion of use, that is, the inclusion of a new age group, must be made by the laboratory responsible for the immunizing agent. To include new audiences in the package insert, the institution needs to conduct studies that demonstrate the safety and efficacy relationship for a given age group, which can be conducted in Brazil or in other countries — in the case of Coronavac, the research was carried out abroad.

Results of an early-stage study by the Chinese pharmacist Sinovac pointed out that the CoronaVac is safe and able to create antibodies against a Covid-19 in children and adolescents. Preliminary data are from clinical trials with more than 500 people between three and 17 years who received two medium or low doses of the immunizing agent or placebo. According to researchers, most Adverse reactions it was mild and only two children had a high fever. In Brazil, the only vaccine approved for children under 18 years of age is that of Pfizer, which is indicated on the package insert for use from 12 years of age onwards. Janssen laboratory received authorization from Anvisa to carry out studies of its vaccine with children under 18 years of age, who are being conducted by the laboratory. This week, the governor of São Paulo, João Doria, announced the start of vaccination for people aged 12 to 17 years. Coronavac is the most used immunizing agent in the state, as it is produced by the Butantan Institute.