The CEO of the National Health Surveillance Agency (Anvisa) Antonio Barra Torres told CNN this Thursday (16) that the authorization for the use of the vaccine against Covid-19 by Pfizer in children aged 5 to 11 years in Brazil is a decision “100% signed by the technical area of the agency”.
“It is always important to remember that as this decision is about a product that is already registered in Brazil, it is 100% signed by the technical area of Anvisa, where there are no directors, but the agency’s publicized technicians,” stated Barra Torres.
According to him, the technicians were guided by the safety and efficacy issues presented by the pharmaceutical company Pfizer, which develops the immunizing agents.
“There were clinical studies with thousands of children of the authorized age group, efficacy levels of 90% and no record of more serious adverse effects. This was very important for approval”, he pointed out.
“Brazil has very unfavorable numbers regarding the involvement of Covid-19 in children in this age group when compared to other countries. In view of these factors, the technical area of Anvisa affirmed this authorization.”
Product will be specific to vaccinate children
Anvisa authorized this Thursday (16) the use of Pfizer’s vaccine against Covid-19 in children aged 5 to 11 years in Brazil. The decision was taken after a technical evaluation of the request submitted by the pharmaceutical company on November 12th.
The dose of the vaccine for this age group will be adjusted and lower (one third) than that used by people over 12 years old. According to Anvisa, the proposal is to have different bottles, with specific dosage for each group. The bottles will be differentiated by color: purple for adults and orange for children.
“Adaptations from adult doses to children’s doses are not made. They are vaccines that leave the production line ready for use at 5 to 11 years old. I believe that the details of obtaining the product are the responsibility of the Ministry of Health.”
As Brazil still does not have the orange cap doses, that is, those adjusted for children, there is no forecast when immunization in this age group will start. Deadline must be defined by the Ministry of Health.
“This product is specific for children. The issue of concern that a bottle of a color opposite to that of adults will come, and as it is a product that leaves the factory for children aged 5 to 11, I understand that it will be necessary”, he told CNN.
Reference: CNN Brasil
