Hurdles that need to be overcome before a self-sustaining mRNA vaccine production ecosystem is established in Africa are summarized and major progress has been made with human, technical and regulatory capacity development.
Abstract
To build mRNA vaccine manufacturing capacity in Africa, significant progress has been made with human, technical and regulatory capacity development. Here we highlight these developments and summarise hurdles that need to be overcome before a self-sustaining mRNA vaccine production ecosystem is established in the continent. Arbuthnot et al. examine efforts to establish mRNA vaccine manufacturing capacity in Africa. They conclude that although major progress has been made in building scientific, manufacturing and regulatory capabilities, long-term sustainability will depend on successful commercialisation, intellectual property development and investment.
Despite remarkable achievements in infectious disease control, more than 20 major pathogens responsible for significant global morbidity and mortality remain without licensed, effective vaccines. This so-called 'vaccine gap' disproportionately burdens low- and middle-income countries (LMICs), exacerbating health inequities and threatening global pandemic preparedness. This review comprehensively examines scientific and technological advances that are actively bridging the vaccine gap, with emphasis on novel platform technologies, immunological innovations, and translational strategies. We conducted a systematic narrative review of literature published between 2015 and 2024, encompassing peer-reviewed articles, WHO reports, clinical trial registries, and regulatory agency databases. Six transformative technology clusters were identified: (1) mRNA and self-amplifying RNA (saRNA) platforms enabling rapid antigen production; (2) viral-vectored vaccines with improved immune breadth; (3) structure-guided antigen design using cryo-electron microscopy and artificial intelligence (AI)-driven protein engineering; (4) broadly neutralising monoclonal antibodies as surrogate vaccine benchmarks; (5) mucosal and inhalable delivery systems targeting tissue-resident immunity; and (6) combination adjuvant systems amplifying magnitude and durability of protective responses. Clinical translation is exemplified by candidates against HIV-1, tuberculosis (TB), respiratory syncytial virus (RSV) in infants, and Plasmodium falciparum malaria. Convergence of AI-assisted rational antigen design, next-generation mRNA platforms, and innovative adjuvant-delivery pairings represents a paradigm shift toward vaccinatable diseases previously considered intractable. Equitable access frameworks and regulatory harmonisation across LMICs remain critical unresolved challenges.
T. Ikrar, Wachyudi Muchsin, Alfi Sophian· Antiviral Research· 0 citations
mRNA vaccine is a novel category in the medical field. Its core mechanism is to deliver mRNA into cells, and then use the host cell system to produce therapeutic proteins or immunogenic proteins, exerting therapeutic effects on the body or stimulating the body to produce antibodies. In addition to COVID-19, mRNA vaccines’ application in targeted tumor therapy is expanding, with numerous clinical trials underway. This review covers the molecular structure of mRNA vaccines, synthesis and purification technologies including nucleoside modification and LNP delivery systems, applications in infectious disease prevention and oncology treatment, and prospects for future development.
Jie Zhou· International Journal of Bio...· 0 citations
Messenger RNA (mRNA) vaccines entered oncology on the strength of a technology validated at population scale for infectious disease prophylaxis, and the therapeutic cancer vaccine field has been reshaped accordingly. The platform permits rapid design-to-dose intervals, encoding of many epitopes within a single product, cell-free manufacture and a dosing schedule compatible with combination immunotherapy. Enthusiasm has nevertheless outpaced the maturity of the clinical evidence. This critical narrative review evaluates the strength, internal consistency and methodological quality of the literature on mRNA cancer vaccines, and distinguishes conclusions that are reasonably secure from those that remain provisional. Literature published between January 2005 and 13 June 2026 was identified through structured searching of biomedical and multidisciplinary scholarly indexes, supplemented by backward and forward citation tracing. Evidence was appraised for design adequacy, endpoint validity, sample size, control structure and consistency across independent groups, then organised thematically rather than study by study.
Four conclusions are well supported. RNA constructs can reliably prime de novo, poly-epitopic CD4-positive and CD8-positive T cell responses against both shared and mutation-derived antigens in humans; vaccine-induced clones can persist for years; formulation and administration route govern the anatomical site of antigen presentation and the character of innate activation; and toxicity in the reported oncology cohorts has been predominantly low grade. Four conclusions remain insecure. Randomised evidence of clinical benefit rests on a single phase 2b melanoma trial whose primary comparison did not reach conventional significance; immunogenicity has been treated as an efficacy surrogate without formal validation; comparative data on antigen-selection strategies, delivery chemistries and dosing schedules are almost entirely absent; and the durability, cardiac and excipient-related safety questions raised by mass prophylactic use have not been examined in repeatedly dosed patients with cancer. Analysis of the reported discrepancies indicates that heterogeneity in neoantigen prediction pipelines, assay thresholds for defining an immune response, and tumour microenvironmental context explain much of the apparent inconsistency between trials. Priorities include randomised platform trials with harmonised immunological endpoints, head-to-head comparison of antigen and delivery strategies, and prospective surrogate-endpoint validation.
Prakash Bharti, Anshul Singh, Hrithika Panday et al.· Asian Journal of Biology· 0 citations
Messenger RNA (mRNA)-based vaccines, including circular RNA (circRNA) and self-amplifying RNA (saRNA), have emerged as the most transformative platforms, offering tremendous potential in prophylactic and therapeutic medicine, particularly in the prevention of infectious diseases and cancer immunotherapy. Nevertheless, their optimization remains limited by the instability of mRNA, its innate immunogenicity, and low protein expression efficiency in vivo. In recent years, rapid advancements in mRNA sequence design and delivery technologies have improved therapeutic protein production and enhanced vaccine efficacy and safety. This article reviews mRNA-based vaccines, including conventional non-replicating mRNA and emerging approaches such as circRNA and saRNA, with a focus on recent progress, sequence optimization, and delivery systems. Additionally, the article highlights recent advancements in computational technologies for vaccine design. Finally, the article outlines current manufacturing challenges and potential solutions.
Zijia Guo, Jiayan Fu, Luna Ran et al.· Molecular Therapy· 0 citations
Vaccination has long been recognised as one of the most effective instruments in the Veterinary Services toolbox for preventing disease, protecting livelihoods and supporting safe and sustainable food production. However, the context in which vaccines operate is changing rapidly. Climate change, geopolitical instability, evolving disease patterns, disruptions to global supply chains, growing antimicrobial resistance and declining public confidence in science are creating new challenges for animal health systems worldwide.
The latest issue of WOAH’s Scientific and Technical Review – Vaccines in action – brings together a collection of articles that reflect these evolving realities. The content of this issue illustrates the complexity of vaccination systems, which involve science, policy, economics, behaviour, governance and international cooperation. Ultimately, the issue demonstrates that successful vaccination programmes depend not only on biological efficacy but also on the institutions, infrastructures and relationships that enable vaccines to generate impact.
B. Cordeiro, F. Fourès· Revue scientifique et techni...· 0 citations
mRNA therapy has emerged as one of the most promising therapeutic approaches in recent years. In this study, we identified key technological challenges and issues and examined organizational requirements necessary to address them and drive the expansion of clinical development. Key technological challenges and issues for the versatile applications of mRNA therapeutics were related to active pharmaceutical ingredients, drug delivery systems and good manufacturing practice. Based on an analysis of therapeutic areas beyond infectious disease, in-house manufacturing facilities of biotech firms did not significantly affect clinical development progress, but they proved necessary for pipeline expansion. A series of case studies suggested a paradigm of dual-purpose manufacturing in early-phase innovation, in which biotech firms developing mRNA therapies aim both to accelerate clinical development and to establish the supply chain infrastructure for broader dissemination and growth. In this early-phase landscape, manufacturing serves as a fundamental strategic pillar in the development of mRNA therapies.
Masashi Abe, Yuri Sano-Fujimoto, Y. Nishida et al.· Drug Discovery Today· 0 citations
