Monoclonal antibodies and oral antivirals are authorized for:
Monoclonal antibodies are also authorized for:
Currently, use as post-exposure prophylaxis is on hold due to previously authorized products lack of effectiveness against the omicron variant (REGEN-COV and bamlanivimab with etesevimab).
Monoclonal antibodies and oral antivirals are not a substitute for vaccination in people for whom vaccination is recommended. Recommend COVID-19 vaccination as the best strategy to prevent severe COVID-19 illness, hospitalization and death.
Monoclonal antibodies are made in a laboratory and work as substitute antibodies that can help fight an infection before the body mounts its own immune response. The antibodies are directed against specific targets on the spike protein of SARS-CoV-2, blocking viral entry into cells. They are recommended by the NIH COVID-19 Treatment Guidelines for outpatient treatment of COVID-19 and post-exposure prophylaxis.
Providers should refer all eligible symptomatic patients for monoclonal antibody treatment. Monoclonal antibodies can be given regardless of vaccination status.
If started soon after the onset of symptoms, monoclonal antibody treatment can decrease the risk of hospitalization and death due to COVID-19 and reduce hospital length of stay and emergency department visits.
As pre-exposure prophylaxis, monoclonal antibodies can reduce the risk of developing symptomatic COVID-19 disease by 77%.
Monoclonal Antibodies Eligibility
Monoclonal antibodies are currently only authorized as treatment and pre-exposure prophylaxis for people who have a medical condition or other factors that increase their risk for severe illness. There are currently no authorized monoclonal antibody products for post-exposure prophylaxis.
For treatment, patients must meet all of these criteria:
For pre-exposure prophylaxis, patients must meet all of these conditions:
For additional guidance, see the Evusheld Prescriber Checklist (PDF).
COVID-19 Monoclonal Antibody Products Under FDA EUA
One product is currently authorized for emergency use for treatment in New York State. Sotrovimab is no longer authorized for use due to the prevalence of the BA.2 omicron subvariant and its reduced activity against this variant.
Note: This product is expected to remain effective against the omicron BA.1 and BA.2 omicron variant sublineages (section 12.4, Fact Sheet for Providers).
Note: This product is expected to remain effective against the omicron variant (section 12.4, Fact Sheet for Providers).
Clinical Considerations for Monoclonal Antibodies
To decide if monoclonal antibody is appropriate for a patient, refer to the COVID-19 Decision Support Tool (PDF, December 30, 2021).
Treatment is most effective when given as soon as possible after symptom onset and should be considered for eligible patients, regardless of vaccination status.
Due to limited clinical efficacy data, bebtelovimab is only authorized as a treatment for patients whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. However, based on the scientific evidence (Phase 2 trial and pharmacokinetic data), it is expected that bebtelovimab may be effective for the treatment of patients with mild-to-moderate COVID-19 to reduce the risk of progression to hospitalization or death (Section 14.4, bebtelovimab Fact Sheet For Providers).
For pre-exposure prophylaxis, long-term efficacy data indicate that EVUSHELD can be re-dosed every six months for people who continue to qualify for therapy. Due to limited supplies, EVUSHIELD is only available to select locations serving populations eligible for pre-exposure prophylaxis.
CDC guidelines no longer recommend delaying COVID-19 vaccination after receiving monoclonal antibody therapy.
Referring or Offering Monoclonal Antibody Therapy
Here are some resources to help you find a referral site:
The following website has information for providers interested in offering monoclonal antibody therapy:
The following websites have information for monoclonal antibody treatment providers:
Two options are available in NYC for offering Evusheld to your patients:
When prescribing through Alto:
For more information on prescribing Evusheld, see the Evusheld Prescriber Checklist (PDF). For information on billing and reimbursement for the administration of Evusheld, visit the CMS Monoclonal Antibodies webpage. For details on coding, refer to the Evusheld Coding Resource (PDF, AstraZeneca).
Evusheld will be offered soon at NYC Health + Hospitals. Community providers interested in referring their patients for Evusheld will need to either complete an eFax form or call 212-COVID-19 (212-268-4319). For more information on how to refer, visit NYC Health + Hospitals Evusheld Treatment.
Patient Education on Monoclonal Antibodies
People at increased risk of severe COVID-19 and their caregivers should be advised:
Authorized oral antiviral treatment works by targeting specific proteins on the SARS-CoV-2 virus to prevent virus replication within the host cell.
If started within five days of symptom onset, oral antivirals reduce the risk of hospitalization and death by 88% with Paxlovid and 30% with molnupiravir.
Oral antivirals are not authorized for pre-exposure or post-exposure prophylaxis to prevent COVID-19.
Oral Antiviral Eligibility
Oral antivirals are authorized for people who have tested positive for SARS-CoV-2, regardless of their vaccination status.
Paxlovid is the preferred oral antiviral. Molnupiravir is approved for use in people ages 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate.
Neither product should be used for longer than five consecutive days.
Oral antiviral therapy is authorized for people who meet all of the following conditions:
Co-administration of Paxlovid can alter the plasma concentrations of other drugs, and other drugs may alter the plasma concentrations of Paxlovid. Consider the potential for drug interactions prior to and during Paxlovid therapy and review concomitant medications during Paxlovid therapy.
The following resources are available to assess and manage potential drug-drug interactions:
Therapy is not recommended for patients with severe kidney (eGFR <30 mL/min) or liver (Child-Pugh Class C) impairment. Dosage adjustments are needed for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). Providers should discuss with patients who have kidney or liver problems whether Paxlovid is right for them.
Paxlovid may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors in patients with uncontrolled or undiagnosed HIV-1 infection. Patients on ritonavir- or cobicistat-containing HIV or HCV regimens should continue their treatment as indicated.
Molnupiravir should be prescribed for patients ages 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate.
Molnupiravir is not recommended during pregnancy. Prescribing providers should advise individuals of childbearing potential to use effective contraception correctly and consistently for the duration of treatment and for four days after the last dose of molnupiravir.
Breastfeeding is not recommended during treatment and for four days after the last dose of molnupiravir. A lactating individual may consider interrupting breastfeeding and pumping and discarding breast milk during this time.
Men of reproductive potential who are sexually active with women of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least three months after the last dose.
COVID-19 Oral Antiviral Products Under FDA EUA
Two products have received emergency use authorization.
Clinical Considerations for Oral Antivirals
Treatment must be administered within five days of symptom onset, but it is most effective when given as soon as possible after symptoms begin. High-risk patients who present within six to 10 days of symptoms onset should be referred for monoclonal antibody therapy. Treatment is appropriate for all eligible patients, regardless of vaccination status.
Prior to initiating treatment with molnupiravir, carefully consider the known and potential risks and benefits. See section on eligibility for information on prescribing precautions.
To decide if oral antiviral treatment is appropriate for a patient, providers can refer to the COVID-19 Decision Support Tool (PDF, December 30, 2021).
Prescribing Oral Antiviral Therapy
Paxlovid and molnupiravir are available in several pharmacies in NYC. To check their daily reported supplies on hand, visit the COVID-19 Therapeutics Locator. See below for instructions on how to send a prescription to Alto Pharmacy for free delivery to patients.
Oral antivirals can only be prescribed by a physician, advanced practice registered nurse or physician assistant. For more information on prescribing Paxlovid, see the Paxlovid Checklist Tool for Prescribers (PDF).
Prescriptions placed with Alto Pharmacy will be delivered to the patient’s preferred address at no cost. Once the prescription is placed, patients can schedule their delivery on the Alto mobile app, by text or by phone with Alto pharmacists.
Alto Pharmacy can offer direct support in English and Spanish and support in numerous other languages through language line.
Prescriptions confirmed by 5 p.m. on weekdays or 1 p.m. on weekends will be delivered the same day.
Complete the following steps to prescribe an oral antiviral medication for a patient:
Patient Education on Oral Antivirals
People at increased risk of severe COVID-19 and their caregivers should be advised:
Patient Handout: COVID-19 Treatments Are Available (PDF)