BRASILIA (Reuters) – The National Health Surveillance Agency (Anvisa) received this Wednesday a second request from the Butantan Institute for approval of the vaccine against Covid-19 CoronaVac for children and adolescents aged 3 to 17 years, the local authority said in a statement .
The laboratory’s first request, in July, was denied by the health agency due to limited data from the studies presented at the time.
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CoronaVac has been authorized for emergency use in the country since January for use in people aged 18 years and over.
According to Anvisa, the request to expand the age range will be analyzed within 30 days.
Also according to the autarchy, “to include new audiences in the package insert, the laboratory needs to conduct studies that demonstrate the relationship of safety and efficacy for a certain age group”, which can be carried out in Brazil or in other countries.
