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Warning

The Food and Drug Administration (FDA), in coordination with the Assistant Secretary for Preparedness and Response (ASPR), will allow distribution of bamlanivimab and etesevimab to resume in selected states, territories, and U.S. jurisdictions for the treatment of mild to moderate COVID-19 and post-exposure prophylaxis of COVID-19 in certain patients based on the combined prevalence of variants resistant to bamlanivimab and etesevimab. Bamlanivimab and etesevimab are not authorized for use in states, territories, and U.S. jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%, as determined by FDA. A list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available here.

Frequently Asked Questions

A list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available here.

On August 20, 2021, the FDA and ASPR announced an extension to the shelf life of bamlanivimab from 12 months to 18 months. Additional details can be found here.

No information is available regarding the safety or effectiveness of administering bamlanivimab and etesevimab after the first dose or completed series of a SARS-CoV-2 vaccine.

The CDC recommends that for partially and fully vaccinated patients who subsequently test positive for COVID-19, prior receipt of a SARS-CoV-2 mRNA vaccine should not influence COVID-19 treatment decisions or the timing of such treatments.1

To date, there is no data available from BLAZE-1 regarding the efficacy and safety of administration of a SARS-CoV-2 vaccine after receipt of bamlanivimab and etesevimab for the treatment of mild to moderate COVID-19.

Based on the estimated half-life of such therapies and evidence suggesting that reinfection is uncommon within the 90 days after initial infection, vaccination should be deferred for at least 90 days after receiving monoclonal antibodies. This is a precautionary measure until additional information becomes available, to avoid potential interference of the antibody therapy with vaccine-induced immune responses. This recommendation applies to people who receive passive antibody therapy before receiving any vaccine dose and between doses. Receipt of passive antibody therapy in the past 90 days is not a contraindication to receipt of COVID-19 vaccine. COVID-19 vaccine doses received within 90 days after receipt of passive antibody therapy do not need to be repeated.1

Bamlanivimab is a recombinant neutralizing human IgG1κ monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region. Bamlanivimab binds to spike protein with a dissociation constant KD = 0.071 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.17nM (0.025 µg/mL).

Etesevimab is a recombinant neutralizing human IgG1κ mAb to the spike protein of SARS-CoV-2, with amino acid substitutions in the Fc region (L234A, L235A) to reduce effector function. Etesevimab binds the spike protein with a dissociation constant KD = 6.45 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.32 nM (0.046 µg/mL).

Bamlanivimab and etesevimab bind to different but overlapping epitopes in the receptor binding domain (RBD) of the spike protein. Using both antibodies together is expected to reduce the risk of viral resistance.

While there are some similarities, here’s how they are different:

  • Monoclonal antibodies, like bamlanivimab and etesevimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Vaccines provide active immunity by helping the body make its own antibodies to protect itself.
  • Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines will generally last longer.
  • Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines.

For information on Eli Lilly and Company's COVID-19 clinical trials, please click here.

Patients interested in participating in one of our clinical trials for a potential COVID-19 treatment should visit Lilly TrialGuide for information regarding eligibility for ongoing trials.

References 1. Centers for Disease Control and Prevention (CDC). Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Updated September 15, 2021. Accessed September 18, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinicalconsiderations.html.

  • Bamlanivimab and etesevimab together have not been approved, but have been authorized for emergency use by the FDA.
  • Bamlanivimab and etesevimab together 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.

Authorized Use

TREATMENT

Bamlanivimab and etesevimab are authorized to be administered together for the treatment of mild to moderate COVID-19 in adults 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

Limitations of Authorized Use: Treatment

Combined Frequency of Variants Resistant to Bamlanivimab and Etesevimab

  • Bamlanivimab and etesevimab are not authorized for use in states, territories, and U.S. jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%.1
    • A list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available here

Use in Patients Who Are Hospitalized or Who Require Oxygen Due to COVID-19

  • Bamlanivimab and etesevimab are not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
  • Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation.

POST-EXPOSURE PROPHYLAXIS

Bamlanivimab and etesevimab administered together are authorized in adults and pediatric individuals (12 years of age or older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:

  • not fully vaccinated2 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications3) AND
    • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)4 OR
    • who are at high risk of exposure to an individual 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).

Limitations of Authorized Use: Post-Exposure Prophylaxis

  • Bamlanivimab and etesevimab are not authorized for use in states, territories, and U.S. jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%.1
    • A list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available here
  • Post-exposure prophylaxis with bamlanivimab and etesevimab is not a substitute for vaccination against COVID-19.
  • Bamlanivimab and etesevimab together are not authorized for pre-exposure prophylaxis for prevention of COVID-19.

Important Safety Information

There are limited clinical data available for bamlanivimab and etesevimab. Serious and unexpected adverse events may occur that have not been previously reported with the use of bamlanivimab and etesevimab together.

WARNINGS
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab and etesevimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy.

Infusion-related reactions, occurring during the infusion or up to 24 hours after infusion, have been observed with administration of bamlanivimab and etesevimab together. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:

  • fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. pre-syncope, syncope), dizziness, and diaphoresis.

Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of bamlanivimab with etesevimab under Emergency Use Authorization.

Clinical Worsening After Bamlanivimab and Etesevimab Administration

Clinical worsening of COVID-19 after administration of bamlanivimab and etesevimab together has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab and etesevimab use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. See Limitations of Authorized Use.

Adverse Reactions

Adverse reactions observed in those who have received bamlanivimab and etesevimab are anaphylaxis (n=1, 0.07%) and infusion-related reactions (n=16, 1.1%). The most common treatment-emergent adverse events included nausea, dizziness, and pruritus. No treatment-emergent events occurred in more than 1% of participants and rates were comparable to placebo.

USE IN SPECIFIC POPULATIONS
Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bamlanivimab and etesevimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bamlanivimab and etesevimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bamlanivimab and etesevimab.

BM ET HCP EUA ISI 27AUG2021

1FDA will make this determination considering current variant frequency data, trends in variant frequency over time, the precision of the estimates, and information regarding emerging variants of concern. FDA will update the list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized as new data and information becomes available. Healthcare providers should refer to the FDA website regularly for updates.

2Individuals 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). See this website for more details.

3See this website for more details.

4Close contact with an infected individual 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). See this website for additional details.

Fact Sheet for Healthcare Providers
Fact Sheet for Patients, Parents and Caregivers (English)
Fact Sheet for Patients, Parents and Caregivers (Spanish)
FDA Letter of Authorization
Dear HCP Letter: FDA Modifies Authorization of Bamlanivimab and Etesevimab
Dear HCP Letter: Revocation of Bamlanivimab Alone EUA
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