Pfizer will Seek Approval from Anvisa for Covid-19 Vaccine in Children Aged 5 to 11 Years
Currently, Pfizer’s vaccine has already been applied in Brazil and other countries to adolescents from 12 years old.
Pfizer said it must submit an application to the National Health Surveillance Agency (Anvisa) for approval of the use of its vaccine against covid-19, ComiRNAty, in children between 5 and 11 years old in November this year.
The Pfizer/BioNTech vaccine was 90.7% effective against the new coronavirus in a clinical trial with children aged 5 to 11, reported the US drugmaker on Friday (22).
Currently, the pharmaceutical vaccine is authorized by Anvisa to be applied to adolescents aged 12 years or older. Its application for young people aged 12 to 15 was authorized in June this year by the health agency.
COMMITTEE RECOMMENDS PFIZER VACCINE FOR CHILDREN
On Tuesday, an external advisory committee of the FDA, the US regulatory agency, recommended applying the vaccine to the 5 to 11-year-olds. The decision is not final, but the official body usually follows the advice of the board, according to The New York Times.
If approved by the FDA, the forecast is that the vaccine can be applied in American children from next week, with a dosage of one third of that applied in adults.
Last Friday, the pharmaceutical made a formal request to the organ, stating that the immunizing agent has an effectiveness of 90.7% in the public from 5 to 11 years old.
In the application approved by the FDA‘s independent committee, the recommended interval is three weeks between the two doses.
APPLICATION OF PFIZER IN BRAZIL
In Brazil, the vaccine developed by Pfizer with BioNTech is the only one authorized for application in adolescents from 12 to 17 years old
Specialists interviewed by the newspaper O Estado de S. Paulo affirm that, if the FDA approves the application of the immunizing agent in children, the decision may weigh favorably for Anvisa to do the same in Brazil.
Even so, it is necessary for Pfizer to submit a formal request to the Brazilian agency and deliver the necessary documents to prove efficacy and safety.
Pfizer will Seek Approval from Anvisa for Covid-19 Vaccine in Children Aged 5 to 11 Years - /10