Guidance for market authorization requirements for COVID-19 vaccines: Requirements for vaccines to address SARS-CoV-2 variants

Variant strains of SARS-CoV-2 are emerging that may affect the level of protection provided by currently authorized COVID-19 vaccines. As a result, manufacturers are adapting authorized COVID-19 vaccines to provide protection against infection and disease caused by virus variants.

Data and Resources

Additional Info

Field Value
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward