‘Show Us The Data': Plan To Speed Pfizer COVID Vaccine OK In Kids Under Five Draws Questions

Experts express cautious optimism that FDA and Pfizer have some data signaling potential efficacy for a vaccine in children under 5 despite an initial trial flop but raise concerns about the absence of public communication amid the apparent rush to an EUA. An advisory committee is scheduled for 15 February.

very cloudy day — FDA and Pfizer Have Offered Little Clarity On What New Data May Justify Earlier Than Expected Vax OK In Under 5 • Source: Alamy

Pfizer Inc. and BioNTech SE initiated a rolling submission of an emergency use authorization on 1 February for a two-shot version of the sponsors' COVID-19 vaccine in children under 6 months through 4 years of age following reports that the US Food and Drug Administration and other government officials had said there may be a way to move forward with an authorization in this age group despite a failed immunobridging study in the 2 to 4 cohort.

The FDA simultaneously announced it will convene its Vaccines and Related Biologics Advisory Committee to review the EUA on 15...