Exploring off-label vaccine use: a survey of the global national immunization technical advisory group network.

Background: National Immunization Technical Advisory Groups (NITAGs) are crucial for enhancing vaccine use in immunization programs, particularly through off-label recommendations. This study sought to assess the adoption and trends of off-label vaccine recommendations made by NITAGs across low-, middle-, and high-income countries since the COVID-19 pandemic.

Methods: An online survey was distributed to NITAG representatives in World Health Organization (WHO) member states, asking questions related to off-label use of vaccines including policies, procedures, legislation, and regulations for NITAGs in participants' countries. Respondents across all six WHO regions were invited to participate.

Results: Respondents from 76 countries participated in the survey (55 %) were NITAG representatives, and 45 % were immunization program managers or from the NITAG secretariat). Most respondents 52 (68 %) reported their NITAG makes off-label recommendations, 18 (24 %) indicated their NITAG does not make off-label recommendations, and 6 (8 %) were unsure of their NITAG's role. There was a noticeable shift relating to off-label vaccine recommendations observed pre, during, and post-pandemic period. Prior to 2022, 25 (48 %) respondents indicated their country recommended off-label vaccines, 11 (21 %) specified off-label recommendations were limited to emergencies as temporary or conditional expansions, and 6 (12 %) were unsure. After 2022, 30 (58 %) respondents indicated their country recommended off-label vaccines, 4 (8 %) specified off-label recommendations were limited to emergencies as temporary or conditional expansions, 18 (35 %) selected no, and 0 (0%) were unsure. While most countries make off-label recommendations, few (15 %) have policies and procedures to support implementation.

Conclusions: Although WHO broadly provides guidance on the mandate and core functions of NITAGs, globally, they have differing mandates and operational capacities related to off-label vaccine use. These findings suggest the need for increased awareness of off-label vaccine recommendations and strengthened dialogue around implementation of off-label recommendations.