The application requests authorization of a 3-µg dose vaccine administered as a three-dose series, the same terms greenlighted by the US Food and Drug Administration in mid-June.
Prior to that, the FDA’s advisory committee unanimously supported the authorization of the Pfizer/BioNTech and Moderna vaccines for the youngest children. Even more than their European counterparts, US parents had been clamoring for the vaccine to be made available to this age group.
For the European authorization, the Comirnaty manufacturers submitted data from a Phase 2/3 randomized, controlled study with 4,526 children aged six months to five years. The study showed that three doses of the vaccine offered a robust immune response with a safety profile similar to a placebo.
According to the companies, adverse events were less common in the youngest age group compared to children between the ages of five and 12.
Author: Dede Williams, Freelance Journalist
