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

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. 2021-07-27 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetycoronavirusCOVID-19pandemicdrugsmedicationsvaccinesmarket authorizationlicensingimporting or sellingCOVID-19 vaccineSARS-CoV-2 variants Guidance for market authorization requirements for COVID-19 vaccines: Requirements for vaccines to address SARS-CoV-2 variantsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines/clinical-testing-requirements-authorization.html Guidance for market authorization requirements for COVID-19 vaccines: Requirements for vaccines to address SARS-CoV-2 variantsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/ligne-directrices-autorisations-mise-marche-vaccins/exigences-matiere-essais-cliniques-autorisation.html

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.

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