According to a tweet by Pfizer, they have submitted a request to the FDA, to begin vaccination for children under 12.
The announcement from Pfizer was made when the company announced eye-opening positive results from the trial conducted on Sept 20, 2021. The trial included 2,268 volunteer participants of 5-11 y/o on whom the vaccine showed robust antibody response when they were put on two smaller dose regimes.
The results were taken in comparison with the results from the Pfizer-BioNTech study previously performed on people of 16-25 y/o with larger doses.
After the positive outcome, Pfizer is certain that there would be no negative effect of the vaccine on children under 12 and is waiting to get approval from the FDA. Now, the FDA will review if the evidence against the statements is enough to conclude whether allowing the shots to children would be the right decision.
The expert panel from both sides will have a debate publicly on the provided evidence and reports on Oct 26.
Additionally, Pfizer added that the third dose that children would get should be given to everyone. This is because the second dose in the children produced an even stronger level of fighting antibodies compared to the adults.
Whilst the risk of COVID-19 is less severe in children as it is in older aged individuals. However, above 707,000 Americans including children have died due to the contagious virus, which spread through the country last year.
The final decision remains to the FDA experts whether they allow Pfizer to begin vaccination of children under 12.
“We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”