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Expanding global access to mRNA vaccines

Nature Reviews Bioengineering (2026)Cite this article

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Abstract

mRNA vaccines benefit from rapid design, scalable manufacturing and strong safety profiles, and they are being preclinically and clinically explored for various infectious diseases, cancer and autoimmune disorders. However, global access to mRNA vaccines remains limited by technical, logistical, economic, regulatory and ethical challenges. In this Review, we discuss the current mRNA vaccine landscape, from approved products to emerging candidates, and outline key barriers to equitable access. We highlight engineering strategies to address these barriers, including thermostability improvements, alternative administration routes, new delivery systems and alternative RNA platforms, such as self-amplifying and circular RNA, as well as the integration of artificial intelligence- and machine learning-based design and optimization. We also discuss the regulatory, ethical and social dimensions of vaccine deployment, as well as the importance of building public trust and community engagement. Coordinated technical and policy advances are essential to remove barriers, enhance access and advance global health equity.

Key points

  • The success of COVID-19 mRNA vaccines established a robust platform that is now expanding to other infectious diseases and non-infectious diseases, including cancer and autoimmune disorders.

  • The full potential of mRNA vaccines can only be realized through broad accessibility.

  • Expanding mRNA vaccine access requires integrated engineering strategies, including thermostability improvements, alternative delivery routes, new carriers and RNA platforms, such as self-amplifying and circular constructs.

  • Artificial intelligence-driven and machine learning-driven mRNA vaccine design and optimization could shorten iteration times, accelerate progress from development to scalable manufacturing and support expanded access.

  • Equitable mRNA vaccine access requires coordinated policy, regulatory and community actions that harmonize global regulations, secure sustained global funding, and engagement of communities to address vaccine hesitancy.

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Fig. 1: Barriers to mRNA vaccine development and manufacturing.
Fig. 2: Engineering strategies to increase the accessibility of mRNA vaccines.

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Authors and Affiliations

  1. David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA

    Behnaz Eshaghi, Robert Langer & Ana Jaklenec

  2. Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA

    Robert Langer

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Conceptualization: B.E. and A.J. Writing — original draft, figures and tables: B.E. Writing — review & editing: B.E., R.L. and A.J. All authors reviewed and approved the manuscript prior to submission.

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Correspondence to Robert Langer or Ana Jaklenec.

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Competing interests

From fiscal year 2021 to the present, R.L. has received licensing fees (to patents in which he was an inventor on) from, invested in, consulted (or was on Scientific Advisory Boards or Boards of Directors) for, lectured (and received a fee), or conducted sponsored research at the Massachusetts Institute of Technology for which he was not paid, for the entities listed in the Supplementary Information. From fiscal year 2021 to the present, A.J. has received licensing fees (to patents on which she was an inventor) from, invested in, consulted (or was on Scientific Advisory Boards or Boards of Directors) for, lectured (and received a fee), or conducted sponsored research at the Massachusetts Institute of Technology for which she was not paid, for the following entities: The Estée Lauder Companies, Moderna Therapeutics, OmniPulse Biosciences, Particles for Humanity, SiO2 Materials Science, VitaKey.

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Related links

African Medicines Agency (AMA): https://www.nepad.org/microsite/african-medicines-agency-ama

African Vaccine Regulatory Forum (AVAREF): https://avaref.afro.who.int/

Afrigen: https://www.afrigen.co.za/

BioNet-Asia: https://bionet-asia.com/partnerships/

Chulalongkorn University: https://www.chulavrc.org/

Coalition for Epidemic Preparedness Innovations (CEPI): https://cepi.net/

COVID-19 Vaccines Global Access (COVAX): https://www.who.int/initiatives/act-accelerator/covax

Decentralized and Accelerated mRNA Vaccine Production System (DeCAFx): https://rnatherapeutics-vaccines-asia.com/seminar/building-a-decentralized-accelerated-mrna-vaccine-production-system-decafx-for-pandemic-preparedness/

First mRNA vaccine factory built from BioNTainer units: https://investors.biontech.de/news-releases/news-release-details/biontech-achieves-milestone-mrna-based-vaccine-manufacturing-0

Gavi, the Vaccine Alliance: https://www.gavi.org/

International Coalition of Medicines Regulatory Authorities (ICMRA): https://icmra.info/drupal/

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): https://www.ich.org/

Mutual Recognition Agreements (MRAs): https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra

Ntensify mRNA platform: https://quantoom.com/ntensify-mrna-production-solution/ntensify-midi-mrna-production-system/

Planned expansions to Senegal and South Africa: https://investors.biontech.de/news-releases/news-release-details/update-first-biontainer-african-based-mrna-manufacturing

Project Orbis: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

Supported by a US $40 million Gates Foundation: https://www.gatesfoundation.org/ideas/media-center/press-releases/2023/10/mrna-vaccine-manufacturing-africa

WHO mRNA Technology Transfer Hub: https://www.who.int/initiatives/mrna-technology-transfer-(mrna-tt)-programme

World Health Organization’s (WHO) Collaborative Registration Procedure (CRP): https://www.who.int/teams/regulation-prequalification/regulation-and-safety/facilitated-product-introduction/collaborative-registration-procedure/crp-for-medicines-and-vaccines-approved-by-the-stringent-regulatory-authorities

World Health Organization’s (WHO) Emergency Use Listing (EUL): https://www.who.int/teams/regulation-prequalification/eul

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Eshaghi, B., Langer, R. & Jaklenec, A. Expanding global access to mRNA vaccines. Nat Rev Bioeng (2026). https://doi.org/10.1038/s44222-026-00424-8

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