Expansion of Coronavac use approved for children and adolescents 6 to 17 years old – Portuguese (Brazil)

At a meeting this Thursday (20/1), the board of directors of Anvisa unanimously approved the pediatric use of CoronaVac. Emergency use approvals for the inclusion of a new age group in the package insert were specifically granted to the public between the ages of 6 and 17, including children and adolescents who are not immunocompromised, based on research conducted in China and other countries. Chile, and presented by Instituto Butantan in the process.

For this public, the approved dose of immunizer, produced from inactivated virus, is the same as used for adults (600 SU in 0.5 ml), with an interval of 28 days between the first and second application.

During the process, Phase I and II clinical studies were evaluated, preliminary data from Efficacy, Safety and Immunogenicity Studies (Phase III) were performed on 14,000 children in five different countries, and Efficacy Study (Phase IV) was performed on millions of children. Children in Chile. The scientific evidence available to date suggests that there are advantages and disadvantages to using the vaccine in a child population. The need to expand the options available for this age group has also been approved. However, it has been clarified that the decision to include Coronavak for this new age group in the National Immunization Program (PNI) was taken by the Ministry of Health.

In Brazil, to date, causal analysis of adverse reactions shows that the Coronavac vaccine is not associated with any deaths in the population for which it was available until then, and that serious adverse events are considered rare or very rare. In the international context, in countries where Coronavac has already been applied to the general population between the ages of 2 and 17, data show that 86% of adverse events recorded between these ages are non-serious. Nonetheless, the approval requirement for the Brazilian public between the ages of 6 and 17 was for continuous monitoring and communication of adverse events that could be recorded, as well as maintaining a management plan for risk reduction, including conducting post-approval safety studies. .

The Collegiate Board has decided to approve based on the technical subsidies offered by the General Management of Medicine and Biological Products (GGMED) and the agency’s Pharmacovigilance Management (GFARM). During the analysis process, medical associations related to the subject were also heard, such as the Brazilian Society of Pediatrics (SBP), the Brazilian Society of Immunization (SBIM), and the Brazilian Society of Infectious Diseases (SBI). These organizations support approving the expansion of Coronavak use to the general public between the ages of 6 and 17.

Technical meetings were also held with representatives of the Chilean Ministry of Health and with the researchers responsible for conducting the Efficacy Study (Phase IV) in that country with the Sinovac Laboratory (China).

Examine the presentation of the pharmacovigilance area.

Check the presentation of the medicine area.

Access the reporter’s vote.

Watch the meeting video.

Historical

On January 17, 2021, emergency use of the Coronavac vaccine was approved in Brazil for people 18 years of age or older.

In July of the same year, the Butantan Institute submitted its first request for immunizer indication for ages 3 to 17. At that time, after evaluation, the request was rejected due to limited data from the research presented at that time.

On December 15, 2021, the Butantan Institute re-submitted the application, based on new data collected in a clinical study conducted with children in Chile.

The emergency use approval granted this Thursday (20/1) is only valid for 6 to 17 year olds. Assessment of the use of children under 6 years of age may occur in the future, however, it is conditional on the presentation of additional data.

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