The technical area of the National Health Surveillance Agency (Anvisa) recommended the use of Coronavac in children and adolescents aged 6 to 17 years who are not immunocompromised. The approval of the immunizer by the agency, however, still depends on the vote of directors, which takes place this Thursday.
The evaluation of the agency’s technical area is for the application of two doses with an interval of 28 days. The formulation used in the pediatric population should be the same as used in adults. Until then, the only vaccine approved in Brazil for the pediatric population is the Pfizer immunizer, which has already started to be applied to children aged 5 to 12 years.
The Butantan Institute asked for the approval of Coronavac for the age group from 3 to 17 years old. Anvisa’s technical analysis, however, considered that the data presented so far are robust only for the age group from 6 to 17 years old.
The evaluation mainly took into account an effectiveness study carried out in Chile with children who received Coronavac. This study of nearly 2 million children and adolescents aged 6 to 16 years who received Coronavac showed that, among the fully immunized group, the vaccine’s effectiveness was 74% in preventing infection and symptomatic disease.
The rate rises to 90% to prevent hospitalization and to 100% to prevent admission to the Intensive Care Unit (ICU), informed the director of Anvisa Meiruze Freitas.
“We see a very important indication of the vaccine’s performance profile with regard to symptomatic cases and also hospitalization in children”, said the general manager of medicines and biological products at Anvisa, Gustavo Mendes Lima Santos. According to Mendes, “all the available scientific evidence suggests that there are benefits and safety for the use of the vaccine in the pediatric population”.
Anvisa’s technical evaluation indicates that Coronavac should not be applied to immunocompromised children (such as those undergoing cancer treatment) because there is still a lack of data on the benefits for this population.
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