The request to the US Food and Drug Administration (FDA) is made while recording outbreak of cases to the children, with their number reaching the highest level of the pandemic in early September, according to data from the American Academy of Pediatrics.
UPDATE: We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our # COVID19 vaccine in children 5 to <12. pic.twitter.com/72Z2HXlkOx
- Pfizer Inc. (@pfizer) October 7, 2021
The FDA has set a date for it October 26th in order for independent counselors to meet and discuss Pfizer's request, making it possible to start vaccinating children shortly afterwards.
A quick approval could help mitigate a possible increase in cases this autumn, with schools be already open nationwide.
The vaccine, which has already been authorized for ages 12-15 and is fully approved for ages 16 and up, has been shown to cause strong immune response in the age group in a clinical trial with 2.268 participants, as the companies announced on September 20th.
The authorization for the Pfizer-BioNTech vaccine for children aged 12-15 was given about a month after the companies submitted the application.
The White House coordinator on the subject Covid-19, Jeffrey Zienz, said today at CNNi that the new Pfizer vaccine for children aged 5-11 may be ready even in early November, if approved by federal regulators.