Pfizer Inc. and BioNTech SE announced that following a request from the U.S. Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to include children 6 months through 4 years of age.
The companies expect to complete the EUA submission in the coming days. This application is for authorization of the first two 3 µg 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.
Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S., with children under 4 accounting for more than 1.6 million of those cases.2 Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge. For the week ending January 22, children under 4 accounted for 3.2% of the total hospitalizations due to COVID-19. If authorization is granted, the Pfizer-BioNTech COVID-19 vaccine would be the first vaccine available to help protect children under 5 years of age from this disease, potentially including future emerging variants of concern.
The request to amend the EUA is based on the totality of data on the safety, tolerability, immunogenicity, and available efficacy of two doses of the Pfizer-BioNTech COVID-19 vaccine. The companies also plan to share these data with the European Medicines Agency and other regulatory agencies around the world.
The companies plan to provide ample supply of the 3 µg dose to meet demand should the FDA approve the EUA application. The companies previously announced planned global supply capacity of approximately four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022.
The Phase 1/2/3 trial initially enrolled 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes approximately 8,300 children. It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years.
Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. On December 17, 2021, Pfizer and BioNTech announced the companies would test a third 3 µg dose given at least two months after the second dose in children under age 5 and a third dose of the 10 µg formulation in children 5 to under 12 years of age.
