They plan to file for the EUA in the coming days.
Pfizer's vaccine is a 3 microgram dose (one tenth the adult dose) given in three shots. The third dose was given two months after the second dose.
This was an immunobridging trial that also collected case data. The 3 doses resulted in an immune response that was non-inferior to an older comparator group of 16-25 year olds that received two shots. Among the case data, there was 80.3% efficacy against symptomatic COVID while Omicron was predominant.
The FDA's advisory committee VRBPAC is meeting June 15th to discuss both Moderna and Pfizer's vaccines for 6 months to 5 years old. So we should see this vaccine approved shortly after that.