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EMA – Publication of a Concept paper on the revision of the COVID-19 vaccines guidance documents

Year: 2024

Type: other

Abstract: The EMA issued a Concept paper on the revision of the COVID-19 vaccines guidance documents. During the COVID-19 pandemic, the EMA Emergency Task Force (ETF) issued two guidance documents on regulatory requirements for COVID-19 vaccines. The first, issued in November 2020, covered clinical requirements for COVID-19 vaccine approval, and the second, issued in February 2021, addressed quality, non-clinical, clinical and clinical requirements for SARS-CoV-2 variant vaccines. Since these document...

Source: OpenEdition (OpenEdition)

DOI: 10.58079/12ja2

Author: Vroby

Language: English

Topic: SARS-CoV-2 and COVID-19 Research

Subfield: Infectious Diseases

Field: Medicine

Domain: Health Sciences

Open Access status: green

OpenAlex ID: W6955547929

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