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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\u201019. 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\u201019 vaccines in an unprecedentedly fast and flexible manner within &lt;1\u00a0year. To ensure the safety and efficacy of these novel vaccines during the clinical development and the routine use in post\u2010licensure 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\u201019 vaccines in Europe.<\/jats:p>","DOI":"10.1111\/all.14868","type":"journal-article","created":{"date-parts":[[2021,4,22]],"date-time":"2021-04-22T22:30:08Z","timestamp":1619130608000},"page":"72-82","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Regulatory concepts to guide and promote the accelerated but safe clinical development and licensure of COVID\u201019 vaccines in Europe"],"prefix":"10.1111","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4100-2830","authenticated-orcid":false,"given":"Ralf","family":"Wagner","sequence":"first","affiliation":[{"name":"Section for Viral Vaccines Department of Virology Paul\u2010Ehrlich\u2010Institut Federal Institute for Vaccines and Biomedicines Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juliane","family":"Mei\u00dfner","sequence":"additional","affiliation":[{"name":"Section for Viral Vaccines Department of Virology Paul\u2010Ehrlich\u2010Institut Federal Institute for Vaccines and Biomedicines Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Grabski","sequence":"additional","affiliation":[{"name":"Section for Viral Vaccines Department of Virology Paul\u2010Ehrlich\u2010Institut Federal Institute for Vaccines and Biomedicines Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuansheng","family":"Sun","sequence":"additional","affiliation":[{"name":"Section for Viral Vaccines Department of Virology Paul\u2010Ehrlich\u2010Institut Federal Institute for Vaccines and Biomedicines Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Vieths","sequence":"additional","affiliation":[{"name":"Vice President Paul\u2010Ehrlich\u2010Institut Federal Institute for Vaccines and Biomedicines Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eberhard","family":"Hildt","sequence":"additional","affiliation":[{"name":"Department of Virology Paul\u2010Ehrlich\u2010Institut Federal Institute for Vaccines and Biomedicines Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,5,21]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"WHO Europe.https:\/\/www.euro.who.int\/en\/health\u2010topics\/health\u2010emergencies\/coronavirus\u2010covid\u201019. 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