​​WHAT ARE THESE MONOCLONAL ANTI-BODIES ?

The Monoclonal Antibodies are investigational medicines used in adults and adolescents (12 years of age and older who weigh at least 88 pounds (40 kg)) who are at high risk for severe COVID‑19, including hospitalization or death for:

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• treatment of mild to moderate symptoms of COVID-19 within 10 days of symptoms onset.

  • OR:

• post-exposure prophylaxis of COVID-19 in persons who are:

  • not fully vaccinated against COVID-19 (Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series [such as the Pfizer or Moderna vaccines], or 2 weeks after a single-dose vaccine [such as Johnson & Johnson’s Janssen vaccine]), or,

  • are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions, including someone who is taking immunosuppressive medications), and

  • someone who is at high risk of being exposed to someone who is infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)

  • have been exposed to someone who is infected with SARS-CoV-2. Close contact with someone who is infected with SARS-CoV-2 is defined as being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (hugging or kissing, for example), sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person (sneezing or coughing, for example).

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These Monoclonal Antibodies are investigational because it is still being studied. There is limited information known about the safety and effectiveness of using either of these therapies to treat people with COVID‑19 or to prevent COVID-19 in people who are at high risk of being exposed to someone who is infected with SARS-CoV-2.

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REGEN-COV, Sotrovimab & Lilly's therapies are not authorized for pre-exposure prophylaxis for prevention of COVID-19 &

NOT A SUBSTITUTE FOR COVID-19 VACCINATION.

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The FDA has authorized the emergency use of these Monoclonal Antibodies  for the treatment of COVID‑19 and the post-exposure prevention of COVID-19 under an Emergency Use Authorization (EUA).