Pfizer, BioNTech Seek COVID Vax EUA in Babies 6 Months Through 4 Years

Pfizer Inc. and BioNTech SE announced that following a request from the U.S. FDA the companies have initiated a rolling submission seeking Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age. 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.
 
If authorization is granted, the Pfizer-BioNTech COVID-19 Vaccine would be the first vaccine available to children under 5 years of age.
  
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 previously announced planned global supply capacity of approximately four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022. The companies continue to supply the vaccine under their existing supply agreement with the U.S. government, which continues through April 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.