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IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?
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.
Afiliación
  • Vandeputte J; International Alliance for Biological Standardization, IABS, Geneva, Switzerland. Electronic address: joris.vandeputte@iabs.org.
  • Saville M; Vaccine R&D, Coalition for Epidemic Preparedness Innovations, CEPI, London, United Kingdom. Electronic address: melanie.saville@cepi.net.
  • Cavaleri M; EMA COVID-19 taskforce, European Medicines Agency, Amsterdam, the Netherlands.
  • Friede M; Initiative for vaccine research, immunization and Vaccines, World Health Organization, Geneva, Switzerland.
  • Hacker A; Global Regulatory Affairs, Coalition for Epidemic Preparedness Innovations, CEPI, London, United Kingdom.
  • Mueller SO; COVID Program Lead, CureVac AG, Germany.
  • Rizzi R; Global Regulatory Affairs, BioNTech, Germany.
  • Smith D; Health Canada, Canada.
  • Thirstrup S; NDA Regulatory Advisory Board, Denmark.
  • Wagner R; Paul-Ehrlich Institute, Langen, Germany.
  • Baay M; P95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: marc.baay@p-95.com.
  • Neels P; International Alliance for Biological Standardization, IABS, Geneva, Switzerland. Electronic address: Pieter.neels@vaccine-advice.be.
Biologicals ; 71: 55-60, 2021 Jun.
Article en En | MEDLINE | ID: mdl-33966960
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Desarrollo de Medicamentos / Vacunas contra la COVID-19 / SARS-CoV-2 / COVID-19 Límite: Humans Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2021 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Desarrollo de Medicamentos / Vacunas contra la COVID-19 / SARS-CoV-2 / COVID-19 Límite: Humans Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2021 Tipo del documento: Article