Table 2.

Priority Actions to Accelerate Access to COVID-19 Pharmacologic Treatments for Children

1) Prioritization and evaluation: Develop a clear prioritized drug portfolio, ensure completion of actionable pediatric clinical trials and facilitate regulatory submission and approvals

• Continue ongoing studies to better characterize the epidemiology, pathophysiology, clinical presentation, infectivity and outcomes of COVID-19 in children, to inform decisions about extrapolation from adult data and optimal pediatric trial design

• Avoid enrolling children in small, underpowered clinical trials and/or of insufficiently promising drug candidates

• Prospectively involve pediatricians in the design, implementation and monitoring of trials in large adaptive trial platforms, even when those are initially restricted to adults

• Rapidly evaluate PK, dose, safety and tolerability in children of therapeutics that have already demonstrated efficacy and safety in adults, extrapolating adult efficacy results to children when appropriate

• Include adolescents in adult trials when appropriate

• Proactively support trial sponsors of new drug candidates to develop pediatric investigation/study plans (PIPs and PSPs), and engage the pediatric scientific community (eg, GAP-f and other pediatric research networks) around those plans early on

2) Development and registration: Establish, support, maintain, and coordinate product development efforts

• Ensure rapid and coordinated development of age-appropriate formulations of any treatments through collaboration between industry, academic institutions, product development partnerships and key pediatric networks (such as GAP-f)

• Consider stability, storage, and packaging requirements for distribution and use in LMICs early on

• Accelerate regulatory review processes through regulatory cooperation and reliance approaches

3) Delivery and safe use: Ensure products are introduced rapidly in a coordinated manner, and healthcare systems and workers are prepared

• Develop access plans that specifically consider introduction and roll-out of pediatric formulations for LMICs as soon as new products are expected and early in the development process (this may involve generic manufacturers and access-oriented public-health voluntary licensing agreements through MPP)

• Align clinical guidance between WHO, national authorities, and medical associations

• Coordinate procurement logistics among various agencies, both internationally (such as with the Global Fund, PAHO Strategic Fund, UNDP and UNICEF) and nationally

Based on the GAP-f framework.

MPP, Medicines Patent Pool.