key: cord-0902359-3t3bhjbq
authors: Klimek, Ludger; Agache, Ioana; Cooke, Emer; Jutel, Marek; Akdis, Cezmi A.; O'Hehir, Robyn
title: COVID‐19 vaccines ‐ the way forward
date: 2021-06-30
journal: Allergy
DOI: 10.1111/all.14995
sha: ef61f53f9c7d58d6c98b6e64aecd335b6533d077
doc_id: 902359
cord_uid: 3t3bhjbq

In a health crisis of the calibre of the COVID‐19 pandemic, the development of effective and safe vaccines is considered the most powerful measure to save lives and minimise the tremendous negative impact on health, social systems and global economics. Vaccines must be evaluated and approved by the appropriate regulatory and/or health authorities. To date, the worldwide regulatory landscape for vaccines is very broad. Bringing COVID‐19 vaccines to the market, the authorities followed at least 51 different pathways, offering various types of accelerated vaccine approval. (1) China, Russia and the United Arab Emirates initiated the vaccine administration before the conclusion of clinical trials. This patchwork of approval processes has revived a long‐standing question, how to better facilitate harmonization in vaccine regulation and whether a harmonized approval process would make the vaccine development procedures more effective, quicker, broadly accessible and administered by the whole world and even less expensive. In this issue, experts from the Paul‐Ehrlich Institute, the regulatory institution for vaccine development in Germany, describe the regulatory procedures, concepts and requirements that are applied to guide and promote the accelerated development and licensure of safe and efficacious COVID‐19 vaccines in Europe.(2)

In a health crisis of the calibre of the COVID-19 pandemic, the development of effective and safe vaccines is considered the most powerful measure to save lives and minimise the tremendous negative impact on health, social systems and global economics.

Vaccines must be evaluated and approved by the appropriate regulatory and/or health authorities. To date, the worldwide regulatory landscape for vaccines is very broad. Bringing COVID-19 vaccines to the market, the authorities followed at least 51 different pathways, offering various types of accelerated vaccine approval. 1 China, Russia and the United Arab Emirates initiated the vaccine administration before the conclusion of clinical trials. This patchwork of approval processes has revived a long-standing question, how to better facilitate harmonization in vaccine regulation and whether a harmonized approval process would make the vaccine development procedures more effective, quicker, broadly accessible and administered by the whole world and even less expensive. In this issue, experts from the Paul-Ehrlich Institute, the regulatory institution for vaccine development in Germany, describe the regulatory procedures, concepts and requirements that are applied to guide and promote the accelerated development and licensure of safe and efficacious COVID-19 vaccines in Europe. 2 Vaccine regulation worldwide began in the USA, when on 1 st July, 1902, the U.S. Congress passed "An act to regulate the sale of viruses, serums, toxins, and analogous products," later referred to as the "Biologics Control Act" that established the government's right to control the manufacturing of vaccines. This is now regarded as the first modern federal legislation to control 

This article is protected by copyright. All rights reserved postponement of some data requirements but based on the reliable demonstration of a positive benefit-risk-balance. 2 Moreover, procedural timelines for data evaluation were drastically reduced and the regulatory assessment at the EMA and FDA was further expedited by applying a "rolling review" approach allowing for a very flexible and time-optimized processing and assessment of individual data packages immediately upon their availability. However, faster approvals must never lead to a reduction in safety. 6 Pharmaceutical industry could use agreed definitions for different types of approval as well as harmonized guidelines including animal models for testing COVID-19 vaccines, the optimal clinical-trial end points and better facilitate their applications. Regulators share data, assessments and compare findings and analyses in order to achieve better decision-taking. For example, pharmacovigilance benefit from collaborative monitoring as faint signals of adverse effects might be too weak to detect in a single country or region. In this way, public confidence could rise and counteract vaccine hesitancy. WHO initiatives, and the International Coalition of Medicines Regulatory Authorities (ICMRA), including regulators from China, Europe and the US, may open the best way forward.

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