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Scientific and Regulatory Lessons Learnt on Building a Chemistry, Manufacturing, and Controls (CMC) Package for COVID-19 Variant Vaccine Updates in the EU—A Regulator’s Perspective

During the COVID-19 pandemic, eight COVID-19 vaccines were authorised in the European Union (EU); as a result of emerging SARS-CoV-2 variants and waning immunity, some of these have been adapted to broaden the immunity against circulating variants. The pace at which variants emerge challenges the te...

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Principais autores: Ragini Shivji, Elena Grabski, Veronika Jekerle
Format: Artigo
Sprog:Inglês
Udgivet: MDPI AG 2024-10-01
Serier:Vaccines
Fag:
COVID-19 vaccine
chemistry, manufacturing, and controls
regulatory approvals
variant updates
Online adgang:https://www.mdpi.com/2076-393X/12/11/1234
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