Approved extension of coronavac usage for children and adolescents aged 6 to 17 years – Portuguese (Brazil)

At a meeting this Thursday (20/1), the board of directors of Anviza unanimously approved the use of Coronavac’s children. Emergency authorization for the inclusion of new age groups in package inserts was specifically granted to the general public, aged 6 to 17 years, to immunized children and adolescents based on studies conducted in several countries, such as China. Chile, and presented by Instituto Butanton in the process.

For this public, the approved dose of the immunosensor generated by the inactivated virus is used for adults (600 SU in 0.5 ml), with a 28-day interval between the first and second application.

During the process, Phase I and II clinical studies were evaluated, preliminary data from the efficacy, safety, and immunogenicity studies (Phase III) were conducted with 14,000 children in five different countries and millions of people from efficacy studies (Phase IV). Children in Chile. The available scientific evidence to date suggests that there are advantages and safeguards to vaccine use in pediatric populations. Authenticity also takes into account the need to expand the available alternatives for this age group. However, it is clear that the decision to include Coronavac for these new age groups in the National Immunization Program (PNI) is up to the Ministry of Health.

In Brazil, so far, an analysis of the cause of adverse reactions shows that the coronavac vaccine is not related to any deaths available to the public, and serious adverse events are considered rare or rare. In the international context, in countries where coronavac has already been applied to the general public aged 2 to 17 years, the data shows that 86% of adverse events recorded in this age group are non-serious types. However, in Brazil, approval for the public between the ages of 6 and 17 is conditional on continuous monitoring and communication of recordable adverse events, as well as the management of a risk reduction plan, which includes the execution of post-authorization safety studies. .

The college board has approved the approval based on technical subsidies presented by the General Management of Medicines and Biological Products (GGMED) and the Agency’s Pharmacovigilance Management (GFARM). During the process of analysis, medical societies of the subject, such as the Brazilian Society of Pediatrics (SBP), the Brazilian Society of Immunizations (SBIm) and the Brazilian Society of Infectious Disease (SBI), were also asked. These units support the authority to extend the use of coronavac to the public aged 6 to 17 years.

Technical meetings were also held with the Sinovac Laboratory (China), with representatives from the Chilean Ministry of Health and responsible researchers conducting efficacy studies (Phase IV) in that country.

Check out the presentation on the Pharmacovigilance area.

Check out the presentation on the Medicines area.

Enter the reporter’s vote.

Watch the video of the meeting.

Historical

The emergency use of the coronavac vaccine for persons 18 years and older in Brazil has been authorized on January 17, 2021.

In July of the same year, the Butanton Institute submitted its first request to prescribe immunizations for 3 to 17 year olds. At the time of the assessment, the request was denied because of limited data from the studies presented at that time.

On December 15, 2021, the Butanton Institute renewed the application based on new data collected in a clinical study with children in Chile.

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

Coronavac 6 to 17 years

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