Emergency Use Authorization (EUA) for the Treatment or Post-Exposure Prophylaxis of COVID-19
Important facts about bamlanivimab and etesevimab
Bamlanivimab and etesevimab are investigational medicines used together in adults and adolescents (12 years of age or older who weigh at least 88 pounds [40 kg]) who are at high risk for developing severe COVID-19, including hospitalization or death for:
- treatment of mild to moderate symptoms of COVID-19, OR
post-exposure prophylaxis for prevention 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 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
- 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). For additional details, go here, or
- 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).
- Bamlanivimab and etesevimab are not authorized for pre-exposure prophylaxis for prevention of COVID-19
Bamlanivimab and etesevimab have not been approved, but have been authorized for emergency use by the FDA. Bamlanivimab and etesevimab are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
For information on the authorized use of bamlanivimab and etesevimab, and mandatory requirements under the Emergency Use Authorization, please review the Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish).
What is COVID-19?
COVID-19 is a disease caused by a type of virus called a coronavirus. Common symptoms include fever, cough, and having trouble breathing.
Some people with COVID-19 have many symptoms, and some have few or no symptoms. And though most people get better within 2 weeks, some people are very sick for a long time — or even die.
There’s no way to know for sure who will get very sick with COVID-19, but some people are at higher risk, including older adults and people with certain health conditions.
You can find more information about COVID-19 at combatcovid.hhs.gov.
What are bamlanivimab and etesevimab?
Etesevimab, pronounced: (e-te-SEV-i-mab)
Bamlanivimab, pronounced: (bam” la niv’ i mab)
Bamlanivimab and etesevimab are neutralizing antibody drugs. When there’s a virus in your body, like COVID-19, your immune system makes antibodies to fight it off. But it takes time for your body to make antibodies for a new virus — and in the meantime, you could get very sick.
Bamlanivimab and etesevimab contain man-made antibodies to help fight the virus. They do not have any COVID-19 virus in them.
In a clinical trial, scientists found that people who took bamlanivimab and etesevimab together within 10 days of COVID-19 symptoms starting were less likely to be admitted to the hospital.
Who is this drug for?
Individuals 121 or older who are considered high risk of getting very sick from COVID-19 may qualify for a monoclonal antibody treatment.
Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to:
Other factors may include neurodevelopmental disorders, sickle cell disease, medical-related technological dependence or other factors found on the CDC website.
Please also reference the Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish). Together, you and your healthcare provider can decide if this treatment is an option for you.