WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20–22 April 2021

Author:

Liu Margaret A.1,Zhou Tiequn2,Sheets Rebecca L.3,Meyer Heidi4,Knezevic Ivana2

Affiliation:

1. ProTherImmune, Lafayette, CA, USA

2. Department of Health Product Policy and Standards, World Health Organization, Geneva, Switzerland

3. Independent Expert, Silver Spring, MD, USA

4. Paul-Ehrlich-Institut, Langen, Germany

Funder

Center for Biologics Evaluation and Research

US Food and Drug Administration

Publisher

Informa UK Limited

Subject

Virology,Infectious Diseases,Drug Discovery,General Medicine,Immunology,Microbiology,Parasitology,Epidemiology

Reference11 articles.

1. 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.

2. 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.

3. 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.

4. World Health Organization. Biologicals [website]. Geneva. [cited 2021 Jul 22] Available from: https://www.who.int/health-topics/biologicals#tab=tab_1.

5. Development of mRNA Vaccines: Scientific and Regulatory Issues

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