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Review
. 2022 Feb 23;40(9):1215-1222.
doi: 10.1016/j.vaccine.2021.11.098.

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

Mic McGoldrick  1 , Thierry Gastineau  2 , Diane Wilkinson  3 , Cristiana Campa  4 , Norbert De Clercq  5 , Andrea Mallia-Milanes  6 , Olivier Germay  7 , Jyothsna Krishnan  8 , M Van Ooij  9 , Michael P Thien  10 , Peter J Mlynarczyk  11 , Edward Saltus  12 , Philippe Juvin  13 , Didier Clenet  14 , Ana Basso  15 , Nora Dellepiane  16 , Sonia Pagliusi  17 , Monique Collaço de Moraes Stávale  18 , Venkatraman H Sivaramakrishnan  19 , Samir Desai  20
Affiliations
Review

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

Mic McGoldrick et al. Vaccine. .

Abstract

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.

Keywords: Covid-19; Digital; Harmonization; Regulatory convergence; Reliance; Risk-based; Science-based; Streamline; Vaccine.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
How to accelerate the supply of vaccines to all populations worldwide – Part I and II.
Fig. 2
Fig. 2
Progression of inter-agency collaboration.
See this image and copyright information in PMC

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