Presentation (CTI)

OBJECTIVES: Government regulatory bodies and multilateral organizations play key roles in determining patient access to vaccines by providing market authorization and reimbursement recommendations that can be implemented by national immunization programs. Patient access to new vaccines is also determined by public health need, specifically infectious disease outbreaks globally, which can motivate regulatory decision making. This study examines how government regulatory bodies, global procurement institutions and National Immunization Technical Advisory Groups (NITAGs) contribute to inequitable vaccine availability and equitable access across 70 countries.
METHODS: This analysis assessed vaccine access trends across 71 high-, middle-, and low-income countries by examining authorization, recommendation, and reimbursement of vaccines introduced since 2000. Included products spanned non-outbreak (e.g., HPV, RSV, MenB) and outbreak-response (e.g., COVID-19, Ebola) immunizations. Introduction of WHO-recommended routine vaccines were also evaluated. New vaccines were identified as new active substances approved by the European Medicines Agency, U.S. Food and Drug Administration, or Japan’s Pharmaceuticals and Medical Devices Agency, including those under an Emergency Use Authorization. Vaccine reimbursement was determined by reviewing public reimbursement listings, including global procurement institutions and NITAGs, in each country.
RESULTS: Vaccine access varied widely across countries. The U.S. introduced all 12 vaccines studied, while most countries, particularly outside Europe, introduced fewer. Authorization was more common than recommendation or reimbursement, with notable gaps in public data. OECD and G20 countries showed mixed patterns, and many LMICs had limited uptake of new vaccines.
CONCLUSIONS: This analysis reveals major global gaps in access to new vaccines introduced since 2000, with high-income countries—especially the U.S. and Europe—leading in approval and adoption. COVID-19 vaccines were a rare exception. Other vaccines, including RSV, remain largely unavailable in many countries, especially LMIC, underscoring the need for greater global coordination, investment, and support to ensure broader, more equitable vaccine availability.