Regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 - Scientific guideline
HumanCOVID-19Vaccines
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:
Keywords: COVID-19, SARS-CoV-2, vaccine, regulatory requirements, variant strain, variant vaccine, parent vaccine, immunogenicity, quality, nonclinical, multivalent