The Instituto Butantan, Brazil’s main vaccine manufacturer, submitted on Tuesday the documents to the Brazilian Health Regulatory Agency (Anvisa), requesting to include children aged between 3 to 5 years in the vaccination group with the development of the vaccine CoronaVac by the Instituto Butantan and the Chinese biopharmaceutical company Sinovac.

The Instituto Butantan has submitted three clinical studies on the safety and efficacy of the vaccine for children, a report on the pharmacovigilance, and a study on its epidemiological impacts.

The studies of the Instituto Butantan show that the vaccine CoronaVac can result in a 58% decrease in the hospitalization rate and a 57% drop in the mortality rate.

The Instituto Butantan made a request for expanding the age group eligible to receive the CoronaVac on March 11. At that time, Anvisa demanded the submission of additional documents such as the report on its pharmacovigilance.