The Butantan Institute, which produces CoronaVac in Brazil, said this Wednesday (December 22) that it was surprised by the National Health Surveillance Agency (Anvisa) by not receiving authorization to apply the vaccine to children and adolescents. Anvisa asked for more data from the research center, to decide on vaccination in the age group of three to 17 years.
According to Butantan, two dossiers with five new studies were sent, as well as pharmacovigilance and safety data from Sinovac, the Chinese manufacturer of CoronaVac. It was the second attempt by Butantan to obtain approval to immunize children in Brazil, against covid-19. The Pfizer vaccine, which was approved by Anvisa for children aged five to 11 years, received yet another green light: that of the Technical Advisory Board on Immunization at Covid-19 (CTAI-COVID). Unanimously, the technicians were in favor of the pediatric application.
On this Wednesday, Anvisa released the complete opinions of the approval of the Pfizer vaccine in children, and the Extraordinary Department for Confronting Covid-19 established that the agency’s decision will be placed in public consultation as of this Wednesday. The contributions presented will be debated at the hearing that will discuss childhood vaccination on the 4th of next month.
For Renato Kfouri, director of the Brazilian Society of Immunizations (SBIm), “it is incomprehensible why the ministry places a technical decision of the National Immunization Program for consultation with the population.” He said he still cannot understand the reasons for making a decision “based on the opinion of lay people, on the opinion of those who are not in the area”.
Vice President Hamilton Mourão defended the public consultation to debate the vaccination of children: “the government is willing to take its decision. Then, there are some conflicts in relation to this matter and he wants to be 100%, let’s say, wearing shoes when starting this process”.
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