Butantan presents new data from studies on the use of Coronavac in children to Anvisa

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The National Health Surveillance Agency (Anvisa) reported that it has received new data from studies conducted in China on the use of Coronavac, produced by the Chinese laboratory Sinovac, in children under 17 years of age. The data were presented by the Butantan Institute, at a meeting held this Friday (5).

According to Anvisa, Butantan has not filed a new request for inclusion of children under 17 in the vaccine indications so far.

In August, Anvisa analyzed and denied a first request, due to data limitations, according to the agency.

Anvisa’s technical team informed that the studies conducted in China need to indicate a favorable relationship for the use of the vaccine, especially in the age group of 3 to 12 years. The content must bring together complete results of the ability to induce the immune response (technically called immunogenicity) and the duration of Coronavac protection in order to evaluate a new application for an indication for the age group.

“The delivery of the results is foreseen in the term of authorization for emergency use granted by Anvisa on January 17 of this year”, says the note from Anvisa.

A new meeting is scheduled for next week between Anvisa and the Butantan Institute to align the discussions, considering data and technical requirements.

Reference: CNN Brasil

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