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Review
. 2022 Jan;77(1):72-82.
doi: 10.1111/all.14868. Epub 2021 May 21.

Regulatory concepts to guide and promote the accelerated but safe clinical development and licensure of COVID-19 vaccines in Europe

Ralf Wagner  1 , Juliane Meißner  1 , Elena Grabski  1 , Yuansheng Sun  1 , Stefan Vieths  2 , Eberhard Hildt  3
Affiliations
Review

Regulatory concepts to guide and promote the accelerated but safe clinical development and licensure of COVID-19 vaccines in Europe

Ralf Wagner et al. Allergy. 2022 Jan.

Abstract

The ongoing COVID-19 pandemic caused by the SARS-CoV-2 coronavirus has affected the health of tens of millions of people worldwide. In particular, in elderly and frail individuals the infection can lead to severe disease and even fatal outcomes. Although the pandemic is primarily a human health crisis its consequences are much broader with a tremendous impact on global economics and social systems. Vaccines are considered the most powerful measure to fight the pandemic and protect people from COVID-19. Based on the concerted activities of scientists, manufacturers and regulators, the urgent need for effective countermeasures has provoked the development and licensure of novel COVID-19 vaccines in an unprecedentedly fast and flexible manner within <1 year. To ensure the safety and efficacy of these novel vaccines during the clinical development and the routine use in post-licensure vaccination campaigns existing regulatory requirements and procedures had to be wisely and carefully adapted to allow for an expedited evaluation without compromising the thoroughness of the regulatory and scientific assessment. In this review, we describe the regulatory procedures, concepts and requirements applied to guide and promote the highly accelerated development and licensure of safe and efficacious COVID-19 vaccines in Europe.

Keywords: COVID-19 pandemic; clinical trial; licensure; regulatory requirements; vaccine.

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Conflict of interest statement

Dr. Ralf Wagner has nothing to disclose. Dr. Juliane Meissner has nothing to disclose. Dr. Elena Grabski has nothing to disclose. Dr. Yuansheng Sun has nothing to disclose. Dr. Stefan Vieths reports personal fees from Schattauer Allergologie Handbuch, personal fees from Elsevier Nahrung smittel allergien und Intoleranzen, personal fees from Karger Food Allergy: Molecular Basis and Clinical Practice, non‐financial support from German Research Foundation, non‐financial support from European Directorate for the Quality of Medicines and Health Care, non‐financial support from European Academy of Allergy and Clinical Immunology, non‐financial support from German Chemical Society (GDCh), non‐financial support from AKM Allergiekongress, non‐financial support from International Union of Immunological Societies, non‐financial support from Spanish Society for Allergy and Clinical Immunology (SEAIC), outside the submitted work. Dr. Eberhard Hildt has nothing to disclose.

Figures

FIGURE 1
FIGURE 1
Schematic outline of the rolling review (RR) procedure. In the RR discrete data packages are submitted for regulatory evaluation immediate upon their availability. In this way, the time before the official submission of the marketing authorization application (MAA) can be spent for regulatory evaluation. Normally, as soon as the MAA is submitted the CHMP opinion and the EC decision can be granted within several days. For more details please see the description in the text
FIGURE 2
FIGURE 2
Schematic comparison of the regular course of clinical trials phases (upper panel) and the adaptive approach applied for COVID‐19 vaccine. In the adaptive approach, certain stages of the clinical development are combined to allow for a more flexible and faster progression of the clinical exploration of COVID‐19 vaccines. The main objectives in each phase are delineated. Further, the schedule and major aspects of the pre‐ and non‐clinical testing programme have been included. For more details please see the description in the text
See this image and copyright information in PMC

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