The Butantan Institute delivered to the National Health Surveillance Agency (Anvisa) the documentation requested by the agency for the request for inclusion of the 3 to 5 year old range in the CoronaVac package insertimmunizing institute in partnership with Chinese pharmaceutical Sinovac, on Tuesday night, 10. The data were required last month, when the Anvisa denied the requestclaiming that the information presented was insufficient to complete the process. The information about the delivery of the data was passed exclusively to LOOK.
According to Butantan, among the data were updates of three reports of ongoing clinical studies on the safety and effectiveness of the vaccine for children, a report on pharmacovigilance and an epidemiological impact study addressing the impacts to the public if it had been immunized. between December 1, 2021 and March 21, 2022.
“The study shows that we would have 58% fewer hospitalizations, 57% fewer deaths and 599 hospitalizations avoided,” he said. The documentation includes two proposals for clinical protocols to be performed in Brazil, one for immunogenicity and safety and the other for effectiveness.
The request to expand the age group eligible to receive the immunizer was made by the Butantan Institute on March 11. At the time, the agency informed that the technical analysis would be carried out within a period of seven days from March 14. On the 18th, Anvisa sent demands from the Pharmacovigilance and Medicines areas to the Butantan Institute, something that did not interrupt the process. Afterwards, meetings were held with representatives of Butantan and of medical and scientific entities to discuss the inclusion of the age group in the package insert of the immunizer.
CoronaVac received authorization from the agency to be applied in the audience over six years old in January of this year.
