Pfizer requests FDA approval for adolescent COVID-19 vaccine, provides update on clinical trial for under-5 age group

Pfizer yesterday said it has submitted a supplemental biologics license application for its COVID-19 vaccine, asking that the Food and Drug Administration expand approval to include individuals age 12 to 15. The supplemental application includes longer-term follow-up data from its ongoing phase 3 clinical trial for this age group, which continues to affirm its extremely high efficacy among these patients.

Pfizer also provided an update on its clinical study of the vaccine’s efficacy and safety among children between 6 months and 5 years old. Each dose for that group is three micrograms. As part of the update, Pfizer revealed that it is evaluating the addition of a third dose for the younger group, administered two months after the completion of an initial two-dose regimen. Pfizer also plans to evaluate the 5-12 age group’s response to a third dose of the 10-micogram formulation currently administered to those children.