The regulatory agency has already approved the immunizer for children and adolescents aged 6 to 17 years in January this year. At the time, Anvisa vetoed the application of the vaccine to the public from 3 to 5 years old, understanding that there was not enough data to authorize the immunizer in this age group.
This request does not interrupt the analysis by the regulatory agency’s technicians, who continue to work on the process. However, it suspends the counting of the period of seven working days that Anvisa has to evaluate the process.
The requirements are requirements issued by Anvisa’s technical team about data, results or information that need to be complemented by the laboratory to complete the order.
“The requirement request is common in the processes of analysis of vaccines and medicines”, he said in a note.
The first part is in the area of ​​pharmacovigilance, which evaluates the monitoring of the immunizing agent based on its use in the population, and was issued this Thursday (17). The second part was issued this Friday (18), by the area of ​​medicines, which evaluates the safety and efficacy aspects of the vaccine.
A meeting with specialists from medical societies related to the topic is scheduled for next Tuesday (22). The objective is to share vaccine efficacy and safety data with the group of external experts so that they can contribute to the technical evaluation process.
“This feature has been adopted by Anvisa in the evaluation of vaccines for children to ensure that any authorization of vaccines against Covid-19 for children is done within the highest possible safety standard”, added the agency.
The agency authorized Dec. 16 to use Pfizer’s drug to immunize children ages 5 to 11.
On January 5, the Ministry of Health announced that children would receive the vaccine without the need for a medical prescription.
The vaccination campaign was opened on January 14 in São Paulo. The first immunized was Davi Seremramiwe Xavante, an 8-year-old indigenous boy.
The vaccination of children and adolescents is a sensitive topic in the Jair Bolsonaro government (PL), which has distorted data and discouraged the immunization of young people. He even threatened to expose the names of Anvisa’s servers who approved the use of Pfizer’s drugs in children.
The Ministry of Health acquired 10 million doses of Coronavac with the Butantan Institute to vaccinate children.
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