The National Health Surveillance Agency (Anvisa) again asked the Butantan Institute, manufacturer of the Coronavac vaccine in partnership with the Chinese laboratory Sinovac, for information on data on the effectiveness of the immunizer for children.
The request concerns the study conducted by the Chilean Ministry of Health, which sought to evaluate data on the effectiveness of the pediatric use of the vaccine against Covid-19.
A batch of data was received by the agency on Monday (10). But this Tuesday (11) Anvisa requested additional clarifications.
Anvisa also requested adjustments to the Institute’s Vaccine Risk Management Plan (RMP).
Butantan had requested authorization from Anvisa for the use of Coronavac in children aged 3 to 17 years in December, but the agency demanded more data, saying that those presented were not sufficient for approval.
Anvisa said in a note that it will have a meeting on Thursday (13), at 10 am, with the Butantan Institute and representatives of medical societies to discuss the data and define possible commitments, in case of authorization to use the vaccine.
The decision will be taken by the Collegiate Board, as it is an approval for emergency use. Each director will draw up his vote and, if there is a simple majority for approval, emergency use will be granted, the regulatory agency said.
So far, the only vaccine that has been approved for pediatric use in Brazil has been Pfizer’s. In December, Anvisa authorized the use of the immunizing agent in children aged 5 to 11 years.
Reference: CNN Brasil
