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Guidance COVID-19Emergency Legal Preparedness and Response

Guidance: COVID-19 Vaccine Emergency Use Authorizations and Off-label Prescribing – Considerations for Healthcare Providers

December 2, 2021


Covid-19 vaccines for various age groups are covered under Emergency Use Authorizations. This guidance provides responses to questions related to whether healthcare providers may prescribe off-label uses of COVID-19 vaccines that have received Emergency Use Authorization but have not yet received a biologics license or other approval from FDA.