Anvisa authorizes Pfizer's vaccine against covid-19 in children
The National Health Surveillance Agency (Anvisa) approved the use of the vaccine produced by the Pfizer-BioNTech consortium, Comirnaty, against covid-19 in children aged 5 to 11 years.
Approval was announced today (16), after a technical assessment by the agency, on the request presented in November, indicating the use of the vaccine for this audience.
The manager recalled that the analyzes had the participation of several experts from both Anvisa and other entities. “We checked safety and tolerability in a first phase. In it, different doses were applied. Based on the result, we came to the conclusion that 10 micrograms should be applied, which is less than that applied to adults”, he said.
He added that, when comparing children aged 5 to 11 with people aged 16 to 25 years [considering the corresponding doses for each group], the presence of antibodies in children was identified.
“We observed satisfactory performance of the vaccine against the Delta variant as well”, he pointed out. “And there are no reports of any serious adverse events, concerns or reports related to very serious cases or mortality due to vaccination. This security profile is very important”, he added.
The Pfizer-BioNTech vaccine had already been authorized for use in adolescents aged 12 years and over.
According to Anvisa, the dose of vaccine for children will be different from that used for people over 12 years. The bottles will also have different colors to avoid application errors.
Text translated using artificial intelligence.
