Journal Article

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

van Holten, Judith, Top, Karina A., Tunis, Matthew, Ruta, Simona, Roberts, Candace, Henaff, Louise, Desai, Shalini, Singh, Awnish

2025

Overview

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. 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. 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. 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.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Advisory Committees / Age groups / Allergy and Immunology / COVID-19 / COVID-19 - epidemiology / COVID-19 - prevention & control / COVID-19 infection / COVID-19 Vaccines / Drug dosages / Electronic mail systems / Emergencies / Epidemics / Global Health / Human papillomavirus / Humans / Immunization / Immunization Programs / Industrialized nations / Labeling / Labels / laws and regulations / Legislation / National Immunization Technical Advisory Group / Off-Label Use - legislation & jurisprudence / Off-Label Use - statistics & numerical data / Off-label vaccines / Pandemics / Policies / Polls & surveys / Public health / SARS-CoV-2 / Schedules / Surveys / Surveys and Questionnaires / Vaccination / Vaccine policy / Vaccines / World Health Organization