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How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation()

The COVID-19 pandemic has shown itself to be an unprecedented challenge for vaccines which are widely recognized as the most important tool to exit this pandemic. We have witnessed vaccine scientists, developers, manufacturers, and stakeholders deliver several vaccines in just about a year. This is...

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Autores principales: McGoldrick, Mic, Gastineau, Thierry, Wilkinson, Diane, Campa, Cristiana, Clercq, Norbert De, Mallia-Milanes, Andrea, Germay, Olivier, Krishnan, Jyothsna, Van Ooij, M., Thien, Michael P., Mlynarczyk, Peter J., Saltus, Edward, Juvin, Philippe, Clenet, Didier, Basso, Ana, Dellepiane, Nora, Pagliusi, Sonia, de Moraes Stávale, Monique Collaço, Sivaramakrishnan, Venkatraman H., Desai, Samir
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8846260/
https://www.ncbi.nlm.nih.gov/pubmed/35180993
http://dx.doi.org/10.1016/j.vaccine.2021.11.098
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author McGoldrick, Mic
Gastineau, Thierry
Wilkinson, Diane
Campa, Cristiana
Clercq, Norbert De
Mallia-Milanes, Andrea
Germay, Olivier
Krishnan, Jyothsna
Van Ooij, M.
Thien, Michael P.
Mlynarczyk, Peter J.
Saltus, Edward
Juvin, Philippe
Clenet, Didier
Basso, Ana
Dellepiane, Nora
Pagliusi, Sonia
de Moraes Stávale, Monique Collaço
Sivaramakrishnan, Venkatraman H.
Desai, Samir
author_facet McGoldrick, Mic
Gastineau, Thierry
Wilkinson, Diane
Campa, Cristiana
Clercq, Norbert De
Mallia-Milanes, Andrea
Germay, Olivier
Krishnan, Jyothsna
Van Ooij, M.
Thien, Michael P.
Mlynarczyk, Peter J.
Saltus, Edward
Juvin, Philippe
Clenet, Didier
Basso, Ana
Dellepiane, Nora
Pagliusi, Sonia
de Moraes Stávale, Monique Collaço
Sivaramakrishnan, Venkatraman H.
Desai, Samir
author_sort McGoldrick, Mic
collection PubMed
description The COVID-19 pandemic has shown itself to be an unprecedented challenge for vaccines which are widely recognized as the most important tool to exit this pandemic. We have witnessed vaccine scientists, developers, manufacturers, and stakeholders deliver several vaccines in just about a year. This is an unprecedented achievement in an environment that was not ready to manage such a global public health crisis. Indeed, the pandemic has highlighted some hurdles that need to be addressed in the system in order to streamline the regulatory processes and be in a situation where life-saving pharmaceutical solutions such as vaccines can be delivered quickly and equitably to people across the globe. More precisely, trade-offs had to be made between the need for regulatory flexibility in the requirements for manufacturing and controls to enable rapid availability of large volumes of vaccines vs the increased stringency and the lack of harmonization in the regulatory environment for vaccines globally. It is also characterized by a high heterogeneity in terms of review and approval processes, limiting equitable and timely access. We review and highlight the challenges relating to several topics, including process validation, comparability, stability, post-approval-changes, release testing, packaging, genetically modified organisms and variants. We see four areas for accelerating access to vaccines which provide solutions for the regulatory concerns, (1) science- and risk-based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. These solutions are not new and have been previously highlighted. In recent months, we have seen some progress at the health authority level, but still much needs to be done. It is now time to reflect on the first lessons learnt from a devastating pandemic to ultimately ensure quick and wide access to medicines and vaccines for the citizens and patients.
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spelling pubmed-88462602022-02-16 How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation() McGoldrick, Mic Gastineau, Thierry Wilkinson, Diane Campa, Cristiana Clercq, Norbert De Mallia-Milanes, Andrea Germay, Olivier Krishnan, Jyothsna Van Ooij, M. Thien, Michael P. Mlynarczyk, Peter J. Saltus, Edward Juvin, Philippe Clenet, Didier Basso, Ana Dellepiane, Nora Pagliusi, Sonia de Moraes Stávale, Monique Collaço Sivaramakrishnan, Venkatraman H. Desai, Samir Vaccine Review The COVID-19 pandemic has shown itself to be an unprecedented challenge for vaccines which are widely recognized as the most important tool to exit this pandemic. We have witnessed vaccine scientists, developers, manufacturers, and stakeholders deliver several vaccines in just about a year. This is an unprecedented achievement in an environment that was not ready to manage such a global public health crisis. Indeed, the pandemic has highlighted some hurdles that need to be addressed in the system in order to streamline the regulatory processes and be in a situation where life-saving pharmaceutical solutions such as vaccines can be delivered quickly and equitably to people across the globe. More precisely, trade-offs had to be made between the need for regulatory flexibility in the requirements for manufacturing and controls to enable rapid availability of large volumes of vaccines vs the increased stringency and the lack of harmonization in the regulatory environment for vaccines globally. It is also characterized by a high heterogeneity in terms of review and approval processes, limiting equitable and timely access. We review and highlight the challenges relating to several topics, including process validation, comparability, stability, post-approval-changes, release testing, packaging, genetically modified organisms and variants. We see four areas for accelerating access to vaccines which provide solutions for the regulatory concerns, (1) science- and risk-based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. These solutions are not new and have been previously highlighted. In recent months, we have seen some progress at the health authority level, but still much needs to be done. It is now time to reflect on the first lessons learnt from a devastating pandemic to ultimately ensure quick and wide access to medicines and vaccines for the citizens and patients. The Authors. Published by Elsevier Ltd. 2022-02-23 2022-02-15 /pmc/articles/PMC8846260/ /pubmed/35180993 http://dx.doi.org/10.1016/j.vaccine.2021.11.098 Text en © 2022 The Authors 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 Review
McGoldrick, Mic
Gastineau, Thierry
Wilkinson, Diane
Campa, Cristiana
Clercq, Norbert De
Mallia-Milanes, Andrea
Germay, Olivier
Krishnan, Jyothsna
Van Ooij, M.
Thien, Michael P.
Mlynarczyk, Peter J.
Saltus, Edward
Juvin, Philippe
Clenet, Didier
Basso, Ana
Dellepiane, Nora
Pagliusi, Sonia
de Moraes Stávale, Monique Collaço
Sivaramakrishnan, Venkatraman H.
Desai, Samir
How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation()
title How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation()
title_full How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation()
title_fullStr How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation()
title_full_unstemmed How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation()
title_short How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation()
title_sort how to accelerate the supply of vaccines to all populations worldwide? part i: initial industry lessons learned and practical overarching proposals leveraging the covid-19 situation()
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8846260/
https://www.ncbi.nlm.nih.gov/pubmed/35180993
http://dx.doi.org/10.1016/j.vaccine.2021.11.098
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