mRNA vaccines and therapeutics beyond COVID-19: A review of the global clinical development landscape, low- and middle-income countries involvement and relevance to their contexts

mRNA vaccines demonstrated transformative potential during the COVID-19 pandemic, yet global access to mRNA research, development, and manufacturing capacity remains unequal. This review systematically maps the global mRNA clinical development landscape beyond COVID-19, based on publicly available sources. A total of 244 vaccine and therapeutic candidates were identified: 123 targeting 23 communicable diseases and 121 targeting 69 non-communicable diseases, including 102 cancer-focused candidates. Two hundred and twenty-seven candidates (93%) were in early clinical development phases and 12 in late-stage development. Eighty-five developers (50 companies, 35 institutes/hospitals) are engaged in this space. Low- and Middle-Income Countries (LMICs) participation was limited to 57 candidates, primarily in upper-middle-income countries. This study reveals a rapidly expanding pipeline for diverse diseases, many aligned with LMIC public health priorities, yet with limited LMIC participation. Equitable inclusion, and collaborations are vital for sustainable global development. This study could inform future LMIC-led mRNA development and manufacturing initiatives.