Paul-Ehrlich-Institut

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Reg­u­la­to­ry Re­sponse to SARS-CoV-2 Mu­ta­tions

COVID-19 vaccine is held in hand (Source: Siam.Pukkato/Shutterstock.com)

Experts from the national competent authorities (NCA) at the European Medicines Agency (EMA) have compiled regulatory requirements for SARS-CoV-2 mutations in a reflection paper. It outlines the quality, nonclinical and clinical data that would be required to support approval of a variant vaccine.

Updated: 01.03.2021