The emergency use authorization granted this Thursday (01/20) is valid only for the age group 6 to 17 years old. The evaluation of the use in children under the age of 6 may occur in the future, but is conditional on the submission of additional data.
Brazil’s National Health Surveillance Agency (Anvisa) approved, the pediatric use of CoronaVac. The emergency use authorization for the inclusion of a new age group in the package insert was granted specifically for the public between 6 and 17 years old, children and adolescents who are not immunocompromised, based on studies conducted in several countries, such as China and Chile, and presented by the Butantan Institute in the process.
The scientific evidence available to date suggests that there are benefits and safety for the use of the vaccine in the pediatric population.
For this audience, the approved dose of the immunizer, produced from inactivated virus, is the same used for adults (600 SU in 0.5 ml), with an interval of 28 days between the first and second application.
CoronaVac vaccine x In Brazil
In Brazil, so far, the CoronaVac vaccine has not been related to any deaths among the public for which it was available until then, and serious adverse events are considered rare or very rare.
In the international scenario, in countries where CoronaVac has already been applied in the 2 to 17-year-old public, data show that 86% of the adverse events reported in this age group are non-severe.
Even so, the approval for the 6 to 17 year old public in Brazil was conditioned to constant monitoring and reporting of adverse events that may be registered, in addition to the maintenance of a management plan to minimize risks, which includes the execution of post-approval safety studies.
BRAZIL: NATIONAL AUTHORITIES INVOLVED IN THE VACCINATION PROCESS
The approval was decided by the Collegiate Board of Directors based on technical subsidies presented by the Agency’s General Management of Drugs and Biological Products (GGMED) and Management of Pharmacovigilance (GFARM).
During the analysis process, medical societies linked to the theme were also heard, such as the Brazilian Society of Pediatrics (SBP), the Brazilian Society of Immunizations (SBIm) and the Brazilian Society of Infectious Diseases (SBI). These entities support the authorization to extend the use of CoronaVac to the public between 6 and 17 years of age.
Technical meetings were also held with the laboratory Sinovac (China), with representatives of the Ministry of Health in Chile and with researchers responsible for conducting effectiveness studies (phase IV) in that country.
- The emergency use of the CoronaVac vaccine in Brazil, for people 18 years of age or older, was authorized on January 17, 2021.
- In July of the same year, the Butantan Institute submitted the first request for indication of the immunizer for the age group 3 to 17 years old. At that time, after evaluation, the request was denied due to limited data from the studies presented at the time.
- On December 15, 2021, the Butantan Institute resubmitted the application, based on new data collected in the clinical study conducted with children in Chile.
- The emergency use authorization granted this Thursday (01/20) is valid only for the age group 6 to 17 years old. Evaluation of the use in children under the age of 6 may occur in the future, but will be subject to submission of additional data.
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