COVID‐19 vaccines ‐ the way forward

Klimek, Ludger; Agache, Ioana; Cooke, Emer; Jutel, Marek; Akdis, Cezmi A.; O'Hehir, Robyn

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)