Anvisa decides whether to approve the use of Coronavac for children aged 3 to 5 years

The board of Anvisa (National Health Surveillance Agency) meets this Wednesday (13) to decide on the request for authorization for emergency use of the Coronavac vaccine in children aged 3 to 5 years.

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 and started to be applied to children and adolescents aged 6 to 17 in January this year.

At the time, the institute’s request was to use the doses in children as young as three years old. However, Anvisa understood that there was not enough data to release vaccination in this age group.

In March, Butantan made a new request to expand the use of Coronavac in children aged 3 to 5 years. But experts from the regulatory agency concluded the following month that the information presented was still insufficient and requested the submission of additional data on ongoing studies.

Since then, several meetings between Anvisa, Butantan and medical entities were held to discuss the inclusion of the age group in the Coronavac leaflet.

The president of the Scientific Department of Immunizations of the SBP (Brazilian Society of Pediatrics), Renato Kfouri, highlighted that the agency has a rigorous standard of evaluation and that, until then, the data presented by Butantan still had limitations, as they had not been obtained in controlled studies.

“The important thing is for Anvisa to have the necessary data for approval. Every approval of a drug needs to have safety and efficacy data and is based on the risk-benefit relationship,” he said.

The regulatory agency has faced pressure from groups of parents, who complain of waiting for the announcement of the decision. The process has taken four months. In Brazil, children from the age of five can be vaccinated with the Pfizer immunizer, but the application of doses below that age is not allowed.

On December 16, Anvisa authorized the use of the Pfizer vaccine to immunize children aged 5 to 11 years. The Ministry of Health announced in January 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 eight-year-old indigenous boy.

In the last month, hospitals had an increase in hospitalizations of children under five for Covid-19. Brazil has recorded an average of two daily deaths from the disease among children below this age.

Such as Sheet showed, an analysis by Observa Infância, a project linked to the Institute for Communication and Scientific and Technological Information in Health (Icict/Fiocruz), indicated that there were 1,439 deaths in this age group in 2020 and 2021, 48% of which were babies of 29 days to 1 incomplete year. 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.

“We need [das vacinas], especially after six months. The first year of life is when the greatest severity of children’s cases is concentrated. The vaccines from Pfizer and Moderna are registered in the United States from six months onwards and have already started to be used there, we are very anxious that they will be used here as well,” said Kfouri.

In June, the United States began applying Covid-19 vaccines to children as young as six months. Since the beginning of the pandemic, the country has recorded 442 deaths among children under the age of five from Covid, that is, almost a third (30.7%) of the total deaths in Brazil.

A survey carried out by Conass (National Council of Health Secretaries) from January to May of this year pointed out that there was an increase in cases of severe acute respiratory syndrome in children under five years of age in 18 of the 20 federative units, and in 17 of them the demand for pediatric intensive care beds.

“We therefore consider that there is evidence of the need to expand the supply of vaccines against Covid-19 to children under five years of age. This assessment was explained by Conass at a meeting of the Tripartite Intermanager Commission, which brings together federal managers , state and municipal, and also in a letter sent to Anvisa”, said the entity in a note.

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 employees who approved the use of Pfizer vaccines in younger people.