Development of mRNA Vaccines: Scientific and Regulatory Issues
Open accessAbstract
The global research and development of mRNA vaccines have been prodigious over the past decade, and the work in this field has been stimulated by the urgent need for rapid development of vaccines in response to an emergent disease such as the current COVID-19 pandemic. Nevertheless, there remain gaps in our understanding of the mechanism of action of mRNA vaccines, as well as their long-term performance in areas such as safety and efficacy. This paper reviews the technologies and processes used for developing mRNA prophylactic vaccines, the current status of vaccine development, and discusses the immune responses induced by mRNA vaccines. It also discusses important issues with regard to the evaluation of mRNA vaccines from regulatory perspectives. Setting global norms and standards for biologicals including vaccines to assure their quality, safety and efficacy has been a WHO mandate and a core function for more than 70 years. New initiatives are ongoing at WHO to arrive at a broad consensus to formulate international guidance on the manufacture and quality control, as well as nonclinical and clinical evaluation of mRNA vaccines, which is deemed necessary to facilitate international convergence of manufacturing and regulatory practices and provide support to National Regulatory Authorities in WHO member states.
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BNT162b1 and BNT162b2 use lipid nanoparticles formulated with Acuitas Therapeutics' ionizable lipid ALC-0315 and a nucleoside-modified mRNA in which all uridines are replaced by N1-methylpseudouridine to enhance mRNA translation.
“The two lead candidates, BNT162b1 and BNT162b2, use LNPs that are formulated using Acuitas Therapeutics’ ionizable lipid ALC-0315 and a nucleoside-modified mRNA in which all uridines are replaced by N1-methylpseudouridine to enhance mRNA translation.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [119]
Pfizer and BioNTech co-developed five mRNA vaccine candidates that encode variants of the spike protein antigen.
“Pfizer and BioNTech co-developed five mRNA vaccine candidates that encode variants of the spike protein antigen119.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [119]
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References 24 · Cited by 114
Research works printed but not linked: 1
- [16]Walsh E.E. Frenck R.W. Falsey A.R. Kitchin N. Absalon J. Gurtman A. Lockhart S. Neuzil K. Mulligan M.J. Bailey R. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates N. Engl. J. Med. 2020 383 2439 2450 10.1056/NEJMoa2027906 33053279 PMC7583697 · DOI · Paper page
- Authors
- Knezevic, I., Liu, M. A., Peden, K., Zhou, T., & Kang, H.-N.
- Affiliations
- Department of Health Product Policy and Standards, World Health Organization, Avenue Appia 20, CH-1211 Geneva, Switzerland
- ProTherImmune 3656 Happy Valley Road, Lafayette, CA 94549, USA
- Center for Biologics Evaluation and Research (US)
- World Health Organization (CH)
- Corresponding author
- Liu, Margaret A.
- Venue
- Vaccines
- Publisher
- MDPI AG
- Published
- 2021-01-23
- Volume
- 9
- Issue
- 2
- Pages
- 81
- ISSN
- 2076-393X (ISSN-L)
- PMC
- PMC7910833
- OpenAlex
- W3122700430
- Cited by
- 114
- References
- 24
- Citations by year
- 2026: 17 · 2025: 14 · 2024: 27 · 2023: 20 · 2022: 19 · 2021: 16
- FWCI
- 6.49
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Vaccines (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Center for Biologics Evaluation and Research (CBER)-U.S. Food and Drug Administration (U01 FD005959)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- mRNA vaccines, vaccine development, COVID-19 vaccines, vaccine regulation, vaccine quality control, vaccine production, immune response, vaccine safety and efficacy, WHO guidelines, international regulatory harmonization, clinical evaluation
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