Top KA, et al. - Given off-label recommendations for vaccine use in distinct age groups, populations, and dosing schedules from the product information are occasionally made by National Immunization Technical Advisory Groups (NITAGs), researchers focused on the rationale, policies as well as procedures for NITAG off-label recommendations by performing an environmental scan of Global NITAG Network members, immunization program managers and regulators in 38 high-, middle- and low-income countries. In 14/26 (54%) countries, recommendations for off-label vaccine use were made; those recommendations were made by the NITAG in 8/14 (57%) countries. Response to disease outbreaks or vaccine shortages were identified as the reasons for off-label vaccine recommendations. Legal concerns, absence of a standard definition for off-label use, and manufacturer reluctance to update product information were reported as the obstacles to off-label recommendations, and confidence in the decision-making process, and transparency of open communication among stakeholders were reported as facilitators. Experts realized that there is a necessity for best practice guidelines that define off-label use and describe a transparent, evidence-based strategy to develop off-label recommendations.