IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?. (June 2021)

• Record Type: Journal Article
• Authors: Vandeputte, Joris; Saville, Melanie; Cavaleri, Marco; Friede, Martin; Hacker, Adam; Mueller, Stefan O.; Rizzi, Ruben; Smith, Dean; Thirstrup, Steffen; Wagner, Ralf; Baay, Marc; Neels, Pieter
• Is Part Of: Biologicals. Volume 71(2021)
• Page Start: 55
• Page End: 60
• Publication Date: 2021-06
• Subjects: Vaccine development -- Regulatory -- Platform technology -- COVID-19; CEPI Coalition for Epidemic Preparedness Innovations -- CMC Chemistry, Manufacturing and Controls -- CMI cell-mediated immunity -- EMA European Medicines Agency -- FDA U.S. Food & Drugs Administration -- IABS International Alliance for Biological Standardization -- MHRA Medicines and Healthcare products Regulatory Agency -- modRNA nucleoside-modified mRNA -- MPSP multimeric protein scaffold particles -- mRNA messenger RNA -- OMCL Official Medicines Control Laboratory -- PfMF Platform Master File -- saRNA self-amplifying mRNA -- uRNA uridine RNA -- WHO World Health Organization -- ZAPI Zoonotic Anticipation and Preparedness Initiative; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2021.04.005
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: The International Alliance for Biological Standardization and the Coalition for Epidemic Preparedness Innovations organized a joint webinar on the use of platform technologies for vaccine development. To tackle new emerging infectious diseases, including SARS-CoV-2, rapid response platforms, using the same basic components as a backbone, yet adaptable for use against different pathogens by inserting new genetic or protein sequences, are essential. Furthermore, it is evident that development of platform technologies needs to continue, due to the emerging variants of SARS-CoV-2. The objective of the meeting was to discuss techniques for platform manufacturing that have been used for COVID-19 vaccine development, with input from regulatory authorities on their experiences with, and expectations of, the platforms. Industry and regulators have been very successful in cooperating, having completed the whole process from development to licensing at an unprecedented speed. However, we should learn from the experiences, to be able to be even faster when a next pandemic of disease X occurs. Highlights: Platform technologies have been essential for rapid vaccine development. A true platform approach seems possible to adapt vaccines to variants. Better understanding of the immune response to components of the platforms is needed. Establishment and adoption of platform principles will require alignment among stakeholders. The nominal target for development and approval of new vaccines should be 100 days.