This pediatric study is consistent with regulatory guidance and follows a previous Phase 1/2/3 trial involving these age groups that demonstrated the original Pfizer-BioNTech COVID-19 Vaccine is well-tolerated and offers a high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.