FDA Advisory Committee votes in favour of granting Emergency Use Authorization for Pfizer-BioNTech SE COVID 19 vaccine in children aged 5 to less than 12 years.

VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy.

The committee reviewed the totality of scientific evidence shared by the companies, including results from a Phase II/III randomized, controlled trial that included ~4,500 children 5 to less than 12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age group received a two-dose regimen of 10-µg doses administered 21 days apart, one-third of the 30-µg dose used for people 12 years and older. This dose level was carefully selected for use in the trial based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study. The Phase II/III trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.

The FDA is expected to make its decision in the coming days. If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), the Pfizer-BioNTech COVID-19 Vaccine will be the first COVID-19 vaccine available for use in children 5 to less than 12 years of age in the U.S.

None of the three vaccines currently authorized in the U.S. are available for children under 12, hindering progress toward knocking down COVID-19 cases and risking disruption to school years.