FDA AdCom backs Comirnaty in children; Africa production plan

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted 17 to 0, with 1 abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for Comirnaty, the COVID-19 vaccine from Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX), in children five to <12 years of age.

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 five to <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 10µg doses administered 21 days apart, one-third of the 30µg 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 seven days after the second dose.

The FDA is expected to make its decision in the coming days. If authorized and subsequently recommended by the US 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 five to <12 years of age in the USA.