May 20, 2022 – Pfizer and BioNTech announced the FDA expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of the Pfizer-BioNTech COVID-19 Vaccine. To date, more than 8 million 5- to 11-year-olds in the U.S. have completed a primary series.
The expanded EUA is based on data from the Phase 2/3 clinical trial, which showed that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group, generating neutralizing antibodies against both the Omicron variant and wild-type SARS-CoV-2 virus regardless of prior SARS-CoV-2 infection. No new safety signals were observed. The third dose was well tolerated, with a safety profile similar to the two-dose primary series.
This Phase 2/3 data builds on efficacy data for the primary two-dose series which showed 90.7% efficacy in children 5 through 11 without prior SARS-CoV-2 infection, measured from 7 days after the second dose, at a period when Delta was the prevalent strain.
The companies have already submitted an application to the European Medicines Agency for a booster dose in this age group and are planning to file with other regulatory agencies around the world. The Pfizer-BioNTech COVID-19 Vaccine is the only COVID-19 vaccine authorized for use in the U.S. for children 5 through 11 years of age.
The Phase 1/2/3 clinical trial evaluating the safety, tolerability, and immunogenicity of a 3-µg formulation of the Pfizer-BioNTech COVID-19 Vaccine on a three-dose schedule in children ages 6 months through 4 years (also known as under 5) is ongoing. Initial data is expected in the coming weeks.
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 in the United States, the European Union, the United Kingdom, Canada 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.