Anvisa (National Health Surveillance Agency) unanimously approved this Wednesday (13) the emergency use of the Coronavac vaccine in children aged 3 to 5 years. The directors’ vote followed the recommendation of the technical area.
Rapporteur Meiruze Freitas stressed in her vote that, despite the “uncertainties that still exist” and even with limited data on the effectiveness of Coronavac, the known benefits of the vaccine indicate that it outweighs known and potential risks.
She highlighted the extensive use of the Coronavac vaccine in children aged 3 to 17 years in China and Chile, and in children and adolescents aged 6 to 17 years in Brazil and among other countries, without any safety alerts having emerged.
She also recalled that there is no therapeutic alternative in Brazil aimed at the pediatric public to prevent or treat Covid-19.
“This vaccine meets the necessary criteria of quality and safety for use in children. Although the effectiveness is limited, the data indicate that the use of Coronavac can help in the prevention of aggravation and deaths by Covid-19”, he highlighted.
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. Researchers linked to the Curumim project were also consulted about a study that tests the efficacy and safety of Coronavac in children and adolescents. The agency also considered other research to support its decision.
Over the past few months, Anvisa has faced pressure from groups of parents, who complained of waiting for the announcement of the decision. 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.
Coronavac’s approval for children as young as three came only after Butantan’s third application.
On January 20 this year, Anvisa released the immunizing agent for children and adolescents from 6 to 17 years old, but vetoed its use in the age group from three to five. The agency understood that there was not enough data to authorize the Coronavac vaccine for the youngest.
The first request, submitted in July last year, was evaluated and later denied by Anvisa due to limited data from the studies presented. The immunizer manufactured by the Butantan Institute has been released for emergency use in Brazil since January 17, 2021 for people aged 18 and over.
Vaccination of children and adolescents is a sensitive issue in the Jair Bolsonaro government (PL), which has distorted data and discouraged childhood immunization. The president even threatened to expose the names of Anvisa’s servers, when the use of Pfizer vaccines in children aged 5 to 11 years was approved on December 16 of last year.
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