On Feb. 1, 2022, Pfizer and BioNTech announced that following a request from the U.S. Food and Drug Administration (FDA) the companies initiated a rolling submission seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days. This application is for authorization of the first two 3 ﾵg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA.