Covid-19: Anvisa to evaluate request for children to be vaccinated
The National Health Surveillance Agency (Anvisa) received a new request from the Butantan Institute indicating the application of the CoronaVac vaccine in children and adolescents aged between 3 and 17 years.
In a statement, Anvisa explained that, for the inclusion of "new audiences in the package insert", it will be necessary for the laboratory to conduct "studies that demonstrate the relationship of safety and efficacy for a certain age group".
Term is 30 days
“This is the laboratory's second request to indicate the immunizing agent for this age group. The first, presented in July, was evaluated by Anvisa and denied due to limited data from the studies presented at that time", informed Anvisa, which now has up to 30 days to evaluate the new request.
Anvisa also recalled that the CoronaVac vaccine is authorized for emergency use in Brazil only for people aged 18 or over.
"The request to expand the use of the vaccine, that is, the inclusion of a new age group, is made by the laboratory responsible for the immunization agent", added the agency.
Text translated using artificial intelligence.
