Regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 - Scientific guideline

This reflection paper outlines the quality, nonclinical and clinical data that would be required to support approval of a variant vaccine, whether monovalent or multivalent.

The requirements apply only when both of the following criteria are met:

• The parent vaccine has been granted marketing authorisation in the EU;
• Except for the SARS-CoV-2 antigen(s) to be presented to the human immune system following vaccination, the manufacturing process and controls and the facilities for vaccine production of the variant vaccine, are the same or very similar to those for the parent vaccine.

Keywords: COVID-19, SARS-CoV-2, vaccine, regulatory requirements, variant strain, variant vaccine, parent vaccine, immunogenicity, quality, nonclinical, multivalent

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