Accelerating optimal approval of priority formulations for antibiotic use in children: meetings report, 7 December 2023 and 19-20 March 2024

In order to fill important gaps in age-appropriate therapies for babies and children, WHO released the first-ever list of priority pediatric formulations for antibiotics on March 24, 2023. This list of antibiotics that urgently require development to treat infections from high-priority pathogens was created using WHO’s Paediatric Drug Optimisation (PADO) approach. In order to speed up regulatory approvals and guarantee fair access to efficient therapies, WHO organized a technical consultation that ended in March 2024, utilizing GAP-f and partners including GARDP and PENTA. The consultation’s objectives were to examine regulatory frameworks and expedite clinical research. This paper summarizes the meeting’s findings, highlighting the cooperative efforts required to promote internationally synchronized, evidence-based care for severe infections in children, avoid delays, and develop critical pediatric formulations.