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. 2022 May;21(5):609-619.
doi: 10.1080/14760584.2022.2042257. Epub 2022 Mar 14.

Clinical development and approval of COVID-19 vaccines

Ulrich Kalinke  1   2 , Dan H Barouch  3 , Ruben Rizzi  4 , Eleni Lagkadinou  4 , Özlem Türeci  4 , Shanti Pather  4 , Pieter Neels  5
Affiliations

Clinical development and approval of COVID-19 vaccines

Ulrich Kalinke et al. Expert Rev Vaccines. 2022 May.

Abstract

Introduction: The coronavirus 19 (COVID-19) pandemic triggered a simultaneous global demand for preventative vaccines, which quickly became a high priority among governments as well as academia and the pharmaceutical industry. Within less than a year after COVID-19 was declared a pandemic, vaccines had received emergency approvals and vaccination campaigns were initiated.

Areas covered: We discuss the several factors that led to the unprecedented, accelerated development and approval of COVID-19 vaccines, which includes optimization of processes by regulatory authorities, redesign of sequential development processes, learnings from previous pandemics, and prior development of novel vaccine platforms.

Expert opinion: Despite unanticipated and complex challenges presented by real-time vaccine development in the context of the evolving COVID-19 pandemic and subsequent ever-changing landscape of public health measures and recommendations, important milestones were reached within extraordinarily short periods and, following roll-out to billions worldwide, the approved vaccines have proven to be well tolerated and effective. Whilst this is an exceptional feat and an example of what can be achieved with collaboration and innovation, there are lessons that can still be learned, including the need for further harmonization between regulatory authorities, modes to react to the pandemic's ever-evolving challenges, and ensuring equitable vaccine access among low-income countries.

Keywords: COVID-19; pandemic; public health; regulatory processes; vaccine development.

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Figures

Figure 1.
Figure 1.
Standard vs. COVID-19 vaccine development process.
Figure 2.
Figure 2.
Key factors in expediting COVID-19 vaccine development and approval.
Figure 3.
Figure 3.
Timeline of the development of COVID-19 vaccines from the start of clinical development through to regulatory approval1.
See this image and copyright information in PMC

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Grants and funding

BioNTech SE provided funding to the Medical Communications agency Scion for the development of the initial outline and literature search.