COVID-19, Pre- & Post-exposure Prophylaxis
by Michael S. Saag, M.D.
last updated
2023-02-01 15:50:49.497910-05:00
© Antimicrobial Therapy, Inc.
COVID-19 Prophylaxis
Pre-exposure
- Primary prevention / pre-exposure prophylaxis for at risk individuals
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The U.S. Food and Drug Administration (link here) revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency.
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- Evusheld (tixagevimab + cilgavimab), administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession; Tixagevimab 300 mg/1.5 mL IM (single dose) + Cilgavimab 300 mg/1.5 mL IM (single dose)), had been recommended as PRE-exposure prophylaxis only for adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are not currently infected with SARS-CoV-2 and who have not recently been exposed to an individual infected with SARS-CoV-2, and who have:
- Moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for health care providers) or
- A history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.
- Evusheld is NOT approved for post-exposure prophylaxis nor for treatment of active, current SARS-CoV-2 infection
- In the pivotal, RC clinical trial, Evusheld recipients had a 77% reduced risk of developing COVID-19 compared to those who received a placebo. The estimated durability of Evusheld is up to 6 months protection.
- Evusheld (tixagevimab + cilgavimab), administered as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession; Tixagevimab 300 mg/1.5 mL IM (single dose) + Cilgavimab 300 mg/1.5 mL IM (single dose)), had been recommended as PRE-exposure prophylaxis only for adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are not currently infected with SARS-CoV-2 and who have not recently been exposed to an individual infected with SARS-CoV-2, and who have:
Post-exposure
- NIH Guidelines (12/1/2022) recommend against the use of bamlanivimab plus etesevimab and casirivimab plus imdevimab (REGEN-COV) for post-exposure prophylaxis (PEP), as the Omicron variant and its subvariants, which are not susceptible to these agents, are currently the dominant SARS-CoV-2 variants circulating in the United States.