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May 14, 2022
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Anvisa and Butantan meet to deal with CoronaVac for children

Anvisa receives first registration request for covid-19 self-test

The National Health Surveillance Agency (Anvisa) reported that technicians from the agency met with representatives of the Butantan Institute, this Friday (13), to discuss expanding the use of the CoronaVac vaccine in children. The activity is part of the vaccine indication request process for children aged 3 to 5 years.Anvisa and Butantan meet to deal with CoronaVac for children

At the beginning of the week, Butantan sent data and information to Anvisa in response to the demand made by the agency to fill gaps in the process. These data are still being analyzed by Anvisa’s technical team. The response received by Anvisa, however, still does not include all the items indicated by the technical team in the requirement request.

According to Butantan, the remaining information, which are updated data from effectiveness studies carried out in Chile, will still be sent to the agency. According to the laboratory, the data were requested from researchers in that country and will be shared with Anvisa.

The release of the vaccine was requested by Butatan to Anvisa on March 11 this year. The institute requested a change to the CoronaVac package insert so that it is also recommended for children aged 3 to 5 years. Currently, in addition to the adult population, the immunizer is released for children and adolescents aged 6 to 17 years. There is no deadline for completing this analysis.

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