This Thursday (20), the National Health Surveillance Agency (Anvisa) authorized the use of the Coronavac vaccine against Covid-19 in children and adolescents aged 6 to 17 years – with restriction of application in immunosuppressed patients in this age group. In an interview with CNN, the general manager of Medicines at Anvisa, Gustavo Mendes, spoke about the process for approval of the immunizer.
The decision was made after a technical evaluation of the second request from the Butantan Institute, submitted on December 15th. Gustavo Mendes highlighted that the request brought new information, mainly referring to a study conducted in Chile.
The request made by Butantan covered the age range from 3 to 17 years. However, Anvisa indicated gaps in studies of effectiveness and safety for the population aged 3 to 5 years and in immunosuppressed.
“Of course, this is a study that has some limitations, which is why we took all this time in several meetings with the Butantan Institute to verify its efficacy and safety. It is possible to recommend for children over 6 years old, below that the data are still precarious”, he said.
Gustavo Mendes pointed out that, when more data becomes available, the agency will be able to assess the expansion of the age group to 3 to 5 years. However, it will be necessary to issue a new order once the decision for the 6-17 year olds is closed.
“If we talk about children aged 3 to 6, 6 to 12, each age group has its specificity and needs specific studies. Each age group needs very delimited criteria and studies for us to reach a conclusion”, he explained.
AT CNN, the manager of Anvisa reiterated the effectiveness of the Coronavac immunizer for children, stating that the studies considered the safety levels.
“The approval we made for Coronavac was based on data that seek to assess safety, we were concerned with making sure that adverse reactions were mild and did not bring impact and concern. And we are concerned with evaluating the indication of efficacy, it is necessary for the vaccine to protect and that is what the studies indicated”, said Mendes.
Reference: CNN Brasil
