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The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines
Once Covid-19 vaccines become available, 5–10 billion vaccine doses should be globally distributed, stored and administered. In this commentary, we discuss how this enormous challenge could be addressed for viral vector-based Covid-19 vaccines by learning from the wealth of formulation development e...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Pharmacists Association®. Published by Elsevier Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7682479/ https://www.ncbi.nlm.nih.gov/pubmed/33242452 http://dx.doi.org/10.1016/j.xphs.2020.11.015 |
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author | Crommelin, Daan J.A. Volkin, David B. Hoogendoorn, Karin H. Lubiniecki, Anthony S. Jiskoot, Wim |
author_facet | Crommelin, Daan J.A. Volkin, David B. Hoogendoorn, Karin H. Lubiniecki, Anthony S. Jiskoot, Wim |
author_sort | Crommelin, Daan J.A. |
collection | PubMed |
description | Once Covid-19 vaccines become available, 5–10 billion vaccine doses should be globally distributed, stored and administered. In this commentary, we discuss how this enormous challenge could be addressed for viral vector-based Covid-19 vaccines by learning from the wealth of formulation development experience gained over the years on stability issues related to live attenuated virus vaccines and viral vector vaccines for other diseases. This experience has led –over time– to major improvements on storage temperature, shelf-life and in-use stability requirements. First, we will cover work on ‘classical’ live attenuated virus vaccines as well as replication competent viral vector vaccines. Subsequently, we address replication deficient viral vector vaccines. Freeze drying and storage at 2–8 °C with a shelf life of years has become the norm. In the case of pandemics with incredibly high and urgent product demands, however, the desire for rapid and convenient distribution chains combined with short end-user storage times require that liquid formulations with shelf lives of months stored at 2–8 °C be considered. In confronting this “perfect storm” of Covid-19 vaccine stability challenges, understanding the many lessons learned from decades of development and manufacturing of live virus-based vaccines is the shortest path for finding promising and rapid solutions. |
format | Online Article Text |
id | pubmed-7682479 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | American Pharmacists Association®. Published by Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-76824792020-11-24 The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines Crommelin, Daan J.A. Volkin, David B. Hoogendoorn, Karin H. Lubiniecki, Anthony S. Jiskoot, Wim J Pharm Sci Special Topic Commentary Once Covid-19 vaccines become available, 5–10 billion vaccine doses should be globally distributed, stored and administered. In this commentary, we discuss how this enormous challenge could be addressed for viral vector-based Covid-19 vaccines by learning from the wealth of formulation development experience gained over the years on stability issues related to live attenuated virus vaccines and viral vector vaccines for other diseases. This experience has led –over time– to major improvements on storage temperature, shelf-life and in-use stability requirements. First, we will cover work on ‘classical’ live attenuated virus vaccines as well as replication competent viral vector vaccines. Subsequently, we address replication deficient viral vector vaccines. Freeze drying and storage at 2–8 °C with a shelf life of years has become the norm. In the case of pandemics with incredibly high and urgent product demands, however, the desire for rapid and convenient distribution chains combined with short end-user storage times require that liquid formulations with shelf lives of months stored at 2–8 °C be considered. In confronting this “perfect storm” of Covid-19 vaccine stability challenges, understanding the many lessons learned from decades of development and manufacturing of live virus-based vaccines is the shortest path for finding promising and rapid solutions. American Pharmacists Association®. Published by Elsevier Inc. 2021-02 2020-11-23 /pmc/articles/PMC7682479/ /pubmed/33242452 http://dx.doi.org/10.1016/j.xphs.2020.11.015 Text en © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Special Topic Commentary Crommelin, Daan J.A. Volkin, David B. Hoogendoorn, Karin H. Lubiniecki, Anthony S. Jiskoot, Wim The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines |
title | The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines |
title_full | The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines |
title_fullStr | The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines |
title_full_unstemmed | The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines |
title_short | The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines |
title_sort | science is there: key considerations for stabilizing viral vector-based covid-19 vaccines |
topic | Special Topic Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7682479/ https://www.ncbi.nlm.nih.gov/pubmed/33242452 http://dx.doi.org/10.1016/j.xphs.2020.11.015 |
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