On Feb. 11, 2022, Pfizer and BioNTech announced plans to extend their rolling submission to the U.S. Food and Drug Administration seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA.

The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 ﾵg doses in this age group was shared with the FDA on an ongoing basis. Cases continued to accumulate according to the study protocol and more data was being generated because rates of infection and illness remain high in children of this age, especially due to the Omicron surge.