The technical area of Anvisa (National Health Surveillance Agency) recommended the approval of the emergency use of the Coronavac vaccine in children aged 3 to 5 years, except for immunocompromised children.
The technicians understand that, although there are still some data gaps regarding Coronavac, the available scientific evidence suggests that there are indications of benefits for the use of the vaccine in the pediatric population.
In this way, they guide the application of the immunizer in children aged 3 to 5 years, except for those who are immunocompromised due to lack of information, in a two-dose schedule with an interval of 28 days.
The general manager of Biological Products at Anvisa, Gustavo Mendes, highlighted the effectiveness of Coronavac against serious cases of Covid-19 and deaths and presented data from a study carried out in Chile, which showed an effectiveness of about 55% against the hospitalization of children. of that age group.
In the event of approval, the technical area also suggests commitments on the part of the Butantan Institute, such as the presentation and careful evaluation of data from controlled clinical studies that are in progress and also the inclusion of the age group in active pharmacovigilance. Helaine Capucho, from Pharmacovigilance management, recommended the creation of a risk communication plan.
The recommendation was presented at a meeting of the agency this Wednesday (13), in which the collegiate board of Anvisa debates whether to authorize the emergency use of Coronavac in children aged 3 to 5 years.
The request to expand the age group in the immunizer package insert was under analysis since March 11, when the Butantan Institute made a new request to the regulatory agency. Before giving its approval, Anvisa asked the laboratory to submit additional data.
Technicians continued working on the process, but the seven-day period the agency would have to assess the case was suspended. Since then, several meetings between Anvisa, Butantan and medical entities were held.
Over the last few months, Anvisa faced pressure from groups of parents, who complained about the wait. In the last month, hospitals have seen an increase in hospitalizations of children under five for Covid-19. Brazil has recorded an average of two daily deaths from the disease among younger children.
An analysis by Observa Infância, a project linked to the Institute for Communication and Scientific and Technological Information in Health (Icict/Fiocruz), showed that there were 1,439 deaths in this group in 2020 and 2021, with 48% of babies aged 29 days to 1 year. incomplete. That means an average of 1.9 per day.
As of June 11 this year, there were at least 291 more deaths under the age of five, an average of 1.8 per day.
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