Healthcare

Anvisa counts again the deadline for analysis of the use of Coronavac in children

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Anvisa (National Health Surveillance Agency) recounted, this Thursday (13), the deadline for analyzing the request of the Butantan Institute to use Coronavac in the vaccination of children and adolescents, from 3 to 17 years old.

The deadline had been suspended last Tuesday (11), after the agency requested additional clarifications about the study conducted by the Chilean government on the vaccination of this public against Covid-19.

This Thursday, Anvisa met with representatives of the Butantan Institute, Chilean researchers, technicians from the Sinovac laboratory and representatives of the SBI (Brazilian Society of Infectious Diseases), the SBP (Brazilian Society of Pediatrics), the SBI (Brazilian Society of Immunology) and the Abrasco (Brazilian Association of Collective Health).

The activity is part of the evaluation process of the application for indication of the immunizer. On that occasion, data from research and studies carried out by the Chilean government during the application of Coronavac in children and adolescents in Chile were presented and analyzed.

The invited experts will issue opinions that will be sent to Anvisa.

On December 15, Butantan forwarded to Anvisa the documentation on the vaccination request for children and adolescents. On the 22nd, the agency made the first technical requirement, blocking the period of 30 days for analysis.

Anvisa reported that 16 of the 30 days of analysis period on the application of Coronavac in children and adolescents have already been used, that is, the agency will still have 14 days to evaluate the Butantan claim after the resumption of the count.

“The evaluation is entering the final stage and close to the final decision. The technical area report will be voted at an extraordinary meeting of Anvisa’s collegiate board”, he said in a note.

In August, Anvisa’s board of directors denied a request for the use of Coronavac in the group from 3 to 17 years old on the grounds of lack of data.

The Ministry of Health evaluates using Coronavac in children, if there is approval from Anvisa. As the vaccine is of the same model applied to adults, states are already planning to allocate stocked doses to the younger public.

The advantage of Coronavac is the availability of doses, due to the fact that the immunizer has stopped being used by the federal government.

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anvisabutantan institutecoronavaccoronaviruscovid vaccinecovid-19healthleafministry of healthvaccine

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