RIO DE JANEIRO, BRAZIL – Brazil’s National Health Regulatory Agency (ANVISA) released a note this Monday (12), informing that, so far, only Pfizer has requested the inclusion in the package insert of applying the Covid-19 vaccine to children 12 years old and older. According to the agency, the request has already been authorized, and the indication for this age group is included in the package insert of the Comirnaty vaccine.
ANVISA also advised that “there is no request from Instituto Butantan to change the package insert of CoronaVac and include children and adolescents.”
“The option to request the inclusion of new indications in the package insert is for the laboratory and must be based on studies that support the intended indication in relation to both safety and efficacy aspects,” ANVISA advised.
It added that, since the beginning of last year, ANVISA has conducted a frequent exchange of information with laboratories involved in the development of Covid-19 vaccines and following all scientific publications on the subject; however, there is still no application for approval of CoronaVac for this age group.
“The decision on registration and post-registration changes of a vaccine or drug is the technical area. For vaccines in emergency use, this decision is of the agency board,” ANVISA explained.