References
- World Health Organization. Main outcomes of the meeting of the WHO Expert Committee on Biological Standardization held from 24 to 28 August 2020. Geneva; 2020. [cited 2021 Jul 23] Available from: https://www.who.int/publications/m/item/WHO-ECBS-aug-2020-executive_summary.
- World Health Organization. Main outcomes of the meeting of the WHO Expert Committee on Biological Standardization held on 9 and 10 December 2020. Geneva; 2020. [cited 2021 Jul 23] Available from: https://www.who.int/publications/m/item/ECBS-Executive-Summary.IF.IK.TW-15_Dec_2020.
- World Health Organization. Prioritizing diseases for research and development in emergency contexts[website] Geneva. [cited 2021 Aug 23] Available from: https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-contexts, accessed 3 August 2021.
- World Health Organization. Biologicals [website]. Geneva. [cited 2021 Jul 22] Available from: https://www.who.int/health-topics/biologicals#tab=tab_1.
- Knezevic I, Liu M, Peden K, et al. Development of mRNA vaccines: scientific and regulatory issues. Vaccines. 2021;9(2):81. [cited 2021 Jul 23]. DOI:10.3390/vaccines9020081.
- Dyer O. Covid-19: countries are learning what others paid for vaccines. Br Med J. 2021;372:n281. [cited 2021 Jul 23]. https://www.bmj.com/content/bmj/372/bmj.n281.full.pdf.
- World Health Organization. Guidelines on clinical evaluation of vaccines: regulatory expectations. In: WHO Expert Committee on Biological Standardization: sixty-eighth report. Geneva: World Health Organization; 2016; Annex 9, WHO Technical Report Series, No. 1004; [cited 2021 Jul 23]. http://www.who.int/entity/biologicals/expert_committee/WHO_TRS_1004_web_Annex_9.pdf?ua = 1, accessed 23 July 2021.
- World Health Organization. Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines. In: WHO Expert Committee on Biological Standardization: sixty-fourth report. Geneva: World Health Organization; 2014; Annex 2, WHO Technical Report Series 987; [cited 2021 Jul 23]. http://www.who.int/biologicals/areas/vaccines/TRS_987_Annex2.pdf?ua=1.
- European Medicines Agency. ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use; 2012. [cited 2021 Jul 23] Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-s2-r1-genotoxicity-testing-data-interpretation-pharmaceuticals-intended-human-use-step_en.pdf, accessed 23 July 2021.
- World Health Organization. Main outcomes of the meeting of the WHO Expert Committee on Biological Standardization held from 18 to 22 October 2021. Geneva; 2021. [cited 2021 Dec 9] Available from: https://www.who.int/publications/m/item/main-outcomes-of-the-meeting-of-the-expert-committee-on-biological-standardization-held-from-18-to-22-october-2021.
- World Health Organization. Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations; 2021. [cited 2021 Dec 9] Available from: https://www.who.int/publications/m/item/evaluation-of-the-quality-safety-and-efficacy-of-messenger-rna-vaccines-for-the-prevention-of-infectious-diseases-regulatory-considerations.