According to the World Health Organization (WHO), there is no formal regulatory guidance specifically for mRNA-based vaccines[1]. However, WHO provides information and regulatory considerations regarding key aspects of the manufacture and quality control, and nonclinical and clinical evaluation, of preventive mRNA vaccines against infectious disease for human use[2]. 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[3]. In the EU no regulatory guidelines presently exist that specifically address mRNA-based vaccines. The existing regulatory framework, however, clearly defines that mRNA-based vaccines in most cases have to be centrally approved[4]. In the UK, both mRNA vaccines were granted temporary regulatory authorization under Regulation 174 of the Human Medicine Regulations 2012[5]. The potential of mRNA vaccine as a technology to rapidly respond to public health emergencies of infectious diseases, in addition to application for prophylactic vaccines for additional infectious diseases, have underscored the need for international regulatory convergence for RNA vaccines[6]. The challenges faced by states in the use of mRNA vaccines include not only regulatory gaps and but also technical issues such as the need for cold storage and transportation.

[1] Evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases: regulatory considerations https://www.who.int/docs/default-source/biologicals/ecbs/reg-considerations-on-rna-vaccines_1st-draft_pc_tz_22122020.pdf?sfvrsn=c13e1e20_3.

[2] Messenger RNA vaccines - World Health Organization (WHO). https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/mrna-vaccines.

[3] Development of mRNA Vaccines: Scientific and Regulatory Issues. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910833/.

[4] The European Regulatory Environment of RNA-Based Vaccines. https://pubmed.ncbi.nlm.nih.gov/27987152/.

[5] Spotlight On MRNA – Regulation of MRNA Vaccines and Therapies - Life .... https://www.mondaq.com/uk/life-sciences-biotechnology-nanotechnology/1133714/spotlight-on-mrna-regulation-of-mrna-vaccines-and-therapies.

[6] See: Messenger RNA vaccines - World Health Organization (WHO). https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/mrna-vaccines.; Evaluation of the quality, safety and efficacy of RNA-based .... https://www.who.int/docs/default-source/biologicals/ecbs/reg-considerations-on-rna-vaccines_1st-draft_pc_tz_22122020.pdf?sfvrsn=c13e1e20_3.; Development of mRNA Vaccines: Scientific and Regulatory Issues. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910833/.