COVID-19 Pre-Exposure Prophylaxis: Information for Providers

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Pre-Exposure Prophylaxis

Vaccination for COVID-19 remains the best protection against infection, hospitalization, and death. However, individuals with immunocompromising conditions, or taking certain immunocompromising medications, may be less likely to mount an appropriate immune response to COVID-19 vaccination, leaving them at risk of serious COVID-19 complications.

Long-acting antibodies for pre-exposure prophylaxis against COVID-19 infection were previously available but are currently not available in the U.S. due to the currently-circulating variants. FDA announced January 26, 2023, that Evusheld (tixagevimab-cilgavimab) is not currently authorized for emergency use in the U.S. because it will not prevent infection by >90% of circulating variants. Evusheld could become available again if there is a shift in susceptible variants. Other products that protect against recent variants are under study. Maine CDC will share further information if and when Evusheld is re-authorized and/or if other products become available. See the most recent Maine CDC Health Advisory on COVID-19 pre-exposure prophylaxis here.

Additional information on this webpage is being maintained to prepare for the possibility of Evusheld being reintroduced or other simlar products become available.

NEW: FDA has distributed information about re-dosing 6 months after a patient received their initial dose. More information is available here:

 

Pre-Exposure Prophylaxis Eligibility

Patient conditions eligible to receive EVUSHELD (Tixagevimab/Cilgabimab) therapy:

    Category 1

    • Lung transplant recipient (any time frame)
    • Small bowel recipient (any time frame)
    • Receipt of the following immunosuppressive medication within the past 12 months (for any condition, oncology and non-oncology):
      • Anti-thymocyte globulin (ATG)
      • Alemtuzumab
      • Anti-B-cell therapy: Rituximab, Ocrelizumab, Ofatumumab
    • Patients with hematologic malignancies who are on active therapy
    • Allogeneic stem cell transplant, within 12 months of transplant
    • Autologous stem cell transplant, within 6 months of transplant
    • Recipient of more than one active transplant, different organs (any time frame)
    • Receipt of anti-CD19 or anti-BCMA (CAR)-T-cell immunotherapy, within six months of treatment
    • Primary or secondary T-cell immunodeficiency, including severe combined immunodeficiency:
      • Agammaglobulinemia (XLA/ARAG)
      • Common variable immunodeficiency (CVID) and similar phenotype with T-cell dysfunction
      • Defects of innate immunity with predominant susceptibility to viral Infections (e.g., WHIM Syndrome)
    • Additional pediatric conditions (age 12–17 years):
      • Combined immune deficiencies with or without immune dysregulation (e.g., APDS, STAT3 GOF, ALPS)
      • Primary immune regulatory disorders with or without immune deficiency (e.g., APECED, XIAP)
      • High-risk or relapsed acute lymphoblastic leukemia/lymphoblastic lymphoma on intensive therapy (not maintenance therapy)

    Category 2

    • Allogeneic stem cell transplant, more than 12 months since transplant
    • Autologous stem cell transplant, more than 6 months since transplant
    • Multiple myeloma, on maintenance therapy
    • Any solid tumor, on active myelosuppressive chemotherapy
    • Any solid organ transplant recipient not otherwise eligible in Category 1
    • Other chronic leukemias, on treatment
    • Patients in Category 3 or Category 4 with more than one qualifying condition

    Category 3

    • Active treatment with high-dose corticosteroids (i.e., more than 20 mg prednisone or equivalent per day when administered for two weeks or longer)
    • Active treatment with other biologic agents that are immunosuppressive or immunomodulatory, not otherwise listed in Categories 1–2
    • Advanced or untreated HIV infection:
      • HIV with CD4 less than 200/mm3 (if aged less than 14 years, CD4% less than 15%)
      • AIDS-defining illness

    Category 4

    • Persons for whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended, due to a history of severe adverse reaction, e.g., severe allergic reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
    • Patients with severe allergic reactions to a COVID-19 vaccine include those with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of a COVID-19 vaccine or known (diagnosed) allergy to a component of a COVID 19 vaccine, any angioedema affecting the airway (tongue, uvula, or larynx), or diffuse rash which also involves mucosal surfaces (e.g., Stevens-Johnson Syndrome).
      • Phone consultation with and/or referral to an allergist is strongly recommended for this group as defined by the CDC since history and/or skin testing may allow these patients to receive a vaccine.
      • NOTE: Severe allergic reactions include anaphylaxis, a progressive life-threatening reaction that can include urticaria (hives) with other symptoms such as wheezing, difficulty breathing, or low blood pressure. Severe allergic reactions do NOT include urticaria beyond the injection site or angioedema (visible swelling) of the lips, facial skin, or skin in other locations. Angioedema of the tongue, uvula, or larynx would NOT be in this category: it is considered a severe allergic reaction.
    • Patients with other non-allergic severe adverse vaccine reactions to a COVID-19 vaccine should undergo review/consultation by an appropriate specialist who is well-informed regarding state and federal guidelines to review possible contraindications. Myocarditis or pericarditis following a dose of mRNA vaccine are considered a contraindication.

Hemostatic Considerations

EVUSHELD is a new combination monoclonal antibody administered as two concomitant IM injections in the gluteal muscle. Maine is experiencing extreme scarcity of blood products to support patients should they have a bleed or hematoma from a deep muscle injection. Thus, strong considerations and judicious clinical discretion is advised for those patients who may be at risk for bleeding from a deep muscle injection.

  • Contraindications for administration in patients who otherwise meet the eligibility per EUA criteria include:
    • Clinically significant heritable bleeding disorder or bleeding diathesis despite a normal platelet count.
    • Platelet count <20,000/uL.
    • On anticoagulation with warfarin, direct acting oral anticoagulation (DOACs) drug(s), or heparin agents, unless they can be safely held in advance.
    • Dual antiplatelet therapy for stent or other considerations.
  • As experience with this drug expands and as stress on the blood supply lessens, these parameters will be re-evaluated.

EVUSHELD Access

For patients:

Patients who currently qualify for treatment, or who have questions about eligibility or whether to get this drug, should contact their primary care provider. Patients who do not have a primary care provider should contact a healthcare facility (see list below) for further information on how to access EVUSHELD at that healthcare facility. Maine CDC is NOT able to coordinate treatment for individual patients.

For healthcare providers:

Healthcare providers with patients who fit into any of the categories listed above can contact one of the following healthcare systems/facilities in Maine to refer their patient(s) for EVUSHELD treatment:

Healthcare System/Facility Contacts for Healthcare Providers
Healthcare System/Facility Location(s) Point of Contact or Referral Form
Cary Medical Center Caribou Jonathan Anderson (janderson@carymed.org) or call 207-498-1228
Central Maine Medical Center Lewiston Joshua Dwinal (DwinalJo@cmhc.org) or Matthew Cox (coxma3@cmhc.org)
Eastern Maine/Northern Light Hospital Bangor https://northernlighthealth.org/Resources/COVID-19/Get-Treatment
MaineGeneral Augusta Arlene McLean (arlene.mclean@mainegeneral.org) or call 207-621-6118 or 207-621-6148
MaineHealth/Maine Medical Center Portland Brian Marden (MARDEB@mainehealth.org)
Mount Desert Island Hospital Bar Harbor Courtney Graham (courtney.graham@mdihospital.org) or call 207-288-5082 x1351
N.E. Cancer Specialists Multiple https://www.newenglandcancerspecialists.org/nononcology-infusion or call 833-826-6327
Redington Fairview Hospital Skowhegan Lisa Caswell (lcaswell@rfgh.net) or call 207-858-2338
St. Joseph Healthcare Bangor Amanda St. Peter (astpeter@covh.org) or call 207-907-1570
York Hospital York Marian Reilly (mreilly@yorkhospital.com) or call 207-351-2314

For healthcare systems/healthcare facilities:

Healthcare systems/healthcare facilities that would like to start getting their own EVUSHELD supply may contact Andy Finch (andrew.finch@maine.gov) at Maine CDC to request details on how to get an allocation.