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Frequently Asked Questions

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.

Neutralizing antibodies provide passive immunity for the duration the antibodies are active in the body.1 It is expected that administration of a vaccine after the duration of passive immunity would stimulate an active immune response, which may then confer long-term immunity against the pathogen.2,3

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.

For questions about access to bamlanivimab and etesevimab together, please visit the Access page of this website to learn more about how product is being distributed across the country and how to identify an infusion site near you. You can also call the Lilly COVID Hotline at 1-855-545-5921.

Partnership with your state health department is crucial for setting up an infusion center at your hospital or other healthcare site. A list of state health departments can be found here. At the bottom of this page, you’ll also find the Lilly Antibody Playbook and Infusion Site of Care Logistics Recommendations. The Lilly COVID Hotline (1-855-545-5921) is also available as a resource if you have additional questions.

Resources

State, territorial, and local public health officials along with individual sites of care looking for assistance with operationalizing the administration of bamlanivimab and etesevimab may view the Bamlanivimab and Etesevimab Antibody Playbook.

These PDFs and links will help provide more details of Eli Lilly’s efforts to respond to the COVID-19 pandemic.

Fact Sheet for Healthcare Providers

FDA Letter of Authorization

Lilly.com COVID-19 Response

Hospital/Infusion Site Checklist

Referral HCP Checklist

These PDFs contain information for patients regarding COVID-19 and treatment options.

Is a COVID-19 Antibody Treatment right for me?

What do I need to know about COVID-19?

What to expect during a COVID-19 Antibody Treatment

External Resources

These hyperlinks will take the viewer to a website external to Lilly.com

Utilization of COVID-19 Antibodies (National Governors Association)

combatCOVID (HHS)

Federal COVID Response Team

National Infusion Center Association (NICA)

How-To-Use-NICA-Locator (Providers)

How-To-Use-NICA-Locator (Prescribers and Patients)

PHE Gov

PHE COVID-19 Monoclonal Antibody Therapeutics Digital Toolkit

Department of Health & Human Services Monoclonal Antibody Playbook

Project Echo mAb Educational Mini-Series

Direct Ordering Information

CMS Monoclonal Antibody Coverage

World Health Organization (WHO)

Centers for Disease Control and Prevention (CDC)

U. S. Food and Drug Administration (FDA)

Report an adverse event to MedWatch

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 January 21, 2021. Accessed January 23, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinicalconsiderations.html. 2. Clem AS. Fundamentals of vaccine immunology. J Glob Infect Dis. 2011;3(1):73-78. http://dx.doi.org/10.4103/0974-777X.77299. 3. Slifka MK, Amanna IJ. Passive immunization. Plotkin's Vaccines. 2018;84-95.e10. http://dx.doi.org/10.1016/B978-0-323-35761-6.00008-0.

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 progressing to severe COVID-19 and/or hospitalization.

  • 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 authorization is terminated or revoked sooner.

Limitations of Authorized Use

  • Bamlanivimab and etesevimab together 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 together 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.

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 with and without 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 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, dizziness, and diaphoresis.

If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

Clinical Worsening After Bamlanivimab Administration

Clinical worsening of COVID-19 after administration of bamlanivimab 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 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 pruritis. 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 17MAY2021

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: Revocation of Bamlanivimab Alone EUA
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