EMS Administration of Monoclonal Antibodies

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Via EMS.gov

The U.S. Food and Drug Administration has issued an Emergency Use Authorization to permit the emergency use of REGEN-COV (casirivimab and imdevimab) co-formulated product, and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Monoclonal antibodies are used to neutralize the COVID-19 virus and intended to prevent progression of disease.

The U.S. Government is currently supplying REGEN-COV (casirivimab and imdevimab) for the treatment and post-exposure prophylaxis of COVID-19. The dosing is the same for both indications (casirivimab 600mg and imdevimab 600mg). The medication can be administered either intravenously (IV) or by subcutaneous (SQ) injection.

EMS agencies throughout the country have been asked or may be asked to assist in the administration of this product through either route of administration.

To assist EMS agencies in planning, the NHTSA Office of EMS and HHS Office of the Assistant Secretary for Preparedness and Response have developed a template protocol for state EMS offices and EMS Medical Directors to use to assist in these programs.

Some states have created blanket state-level authorizations for EMS administration; some states will still require provider authorization prior to administration. Please follow local protocols and regulations. This template is only designed to facilitate the development of those local protocols as needed. Please contact the NHTSA Office of EMS with any questions.

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