COVID-19: Vaccines and Therapeutics (Provider Information)

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Maine CDC COVID-19 Clinician Informational Sessions

Maine CDC holds monthly webinars for clinician with updates on COVID-19 vaccines and therapeutics.

Future sessions: : July 12, August 9, September 13, October 11, November 8, December 13

  • Maine CDC COVID-19 Clinician Informational Session
  • Held on the 2nd Tuesday of every month at 12pm
  • https://mainestate.zoom.us/j/83384535429
  • Meeting ID: 833 8453 5429
  • One tap mobile
  • +13017158592,,83384535429# US (Washington DC)
  • +13126266799,,83384535429# US (Chicago)

Recent sessions:

Overview of COVID-19 Vaccines and Therapeutics

Summary of Vaccines and Therapeutics

All persons age 5 years and older

COVID-19 vaccines and boosters

US CDC: Use of COVID-19 Vaccines in the United States

Maine CDC: COVID-19 Vaccine Providers Portal

Persons age 5 years and older with moderate or severe immunocompromise

COVID-19 vaccines and boosters

Long-acting antibody for pre-exposure prophylaxis

US CDC: COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised

Maine CDC: COVID-19 Vaccine Providers Portal

COVID-19 Pre-Exposure Prophylaxis (Provider Information)

Persons exposed to COVID-19 who have not tested positive (i.e., post-exposure prophylaxis)

No treatments currently available

Note: monoclonal antibody therapies that were previously available for this purpose are no longer available due to poor effectiveness for current variants

Persons with asymptomatic COVID-19 infection

No treatments currently available

Symptomatic treatment only

Monitor closely for the development of COVID-19 symptoms and treat if high-risk. Ensure readiness to test and access treatment if symptomatic and eligible.

Persons with mild or moderate COVID-19 symptoms and a positive test who are UNDER 40 years old and DO NOT have any underlying medical conditions that place them at high risk for severe disease

No treatments currently available

Symptomatic treatment only

Persons with mild or moderate COVID-19 illness, a positive test (NAAT or antigen), and age 40+ years or one or more underlying conditions

Oral antivirals

IV antivirals

IV monoclonal antibody therapy

See additional treatment information below

For information on pharmacies that can fill a prescription from any doctor, and Test-to-Treat locations where patients can get tested, seen by a provider, and treated, see COVID-19 Treatment in Maine (Patient Information).

Persons with severe or critical COVID-19 symptoms

Advanced care

These persons should be seen urgently. Further treatment information is not covered here.

COVID-19 vaccination remains the best way to prevent COVID-19 infection, hospitalization, and death. Vaccination is recommended for all persons 5 years and older. Booster doses are also recommended and are an essential component of preventing infection and severe disease as COVID-19 continues to evolve. COVID-19 vaccine for persons age 6 months to <5 years is expected to become available in June 2022.

People with immunocompromising conditions or people who take immunosuppressive medications or therapies are at increased risk for severe COVID-19. These individuals are expected to have inadequate immunological response to the standard vaccination schedule; US CDC recommends they get additional vaccine doses to provide stronger protection against COVID-19. After vaccination, these individuals may also get additional pre-exposure prophylaxis to further reduce the risk of infection and severe disease, as recommended by NIH treatment guidelines. For more information on this a long-acting antibody therapy, including which patients can get this therapy, which healthcare systems in Maine offer it, and how to get supplies at your healthcare facility, see COVID-19 Pre-Exposure Prophylaxis (Provider Information).

Infections, hospitalizations, and deaths continue to occur in unvaccinated individuals and in vaccinated individuals. Several medications are available that can reduce the risk of progressing from mild illness to severe disease. Treatment is available for persons who have COVID-19 symptoms, a positive direct test (either NAAT or antigen), and are at high risk for severe disease based on age (40+) or certain conditions.

  • For patients exposed to COVID-19 who do not have symptoms or a positive test, there are no treatments available for post-exposure prophylaxis. (Monoclonal antibody therapies previously available for this purpose are no longer available due to poor effectiveness for current variants.)
  • For patients who have tested positive for COVID-19 infection and do not have COVID-19 symptoms, there are currently no treatments available for asymptomatic infection.
  • Oral and IV antivirals and IV monoclonal antibodies are available for non-hospitalized adults age 40 years and older, and people with certain Underlying Medical Conditions Associated with High Risk for Severe COVID-19 (US CDC) placing them at high risk for severe illness, who have COVID-19 symptoms and a positive test. (Note that, for the purposes of eligibility for these treatments, persons who are hospitalized for a non-COVID reason can be treated similarly to persons who are not hospitalized.)

Encourage patients at high risk for severe disease to test early and treat early, even if symptoms are mild. Many people with COVID-19 are at high risk for severe disease and can receive treatment, yet they do not learn about treatment options in time to access early treatment, or they have difficulty obtaining a drug prescription within the recommended timeframe. To aid in sharing information with patients about the availability of these medicines, we created simple graphics that you can print, post, and give to patients.

To find pharmacies in Maine that can fill a prescription for oral antivirals, and Test-to-Treat locations in Maine where patients can get tested, see a provider, and get treated, go to COVID-19 Treatment in Maine.

COVID-19 Treatment for Non-Hospitalized Patients

The U.S. Food and Drug Administration (FDA) has authorized or approved several COVID-19 therapies for patients who have COVID-19 symptoms, a positive COVID-19 PCR or antigen test, and are at high risk for severe disease (age 40+ or one or more high risk conditions). Eligibility is set by the FDA. Please note that off-label prescribing is not allowed for drugs that are made available under Emergency Use Authorization.

Medicine Eligibility and notes Resources

Paxlovid (nirmatrelvir/ritonavir) (PO)

  • Oral therapy (5 days)
  • Start within 0–5 days after COVID-19 symptoms begin

Individuals 12+ years old at high risk for progression to severe COVID-19.

Treatment of choice for non-hospitalized patients (per NIH treatment guidelines (PDF)).

FDA: Paxlovid EUA Fact Sheet for Healthcare Providers (PDF)

FDA: Paxlovid EUA Fact Sheet for Patients, Parents, and Caregivers (PDF)

PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers

FDA Updates on Paxlovid for Health Care Providers

Veklury (remdesivir) (IV)

  • IV therapy (daily x 3 days)
  • Start within 0–7 days after COVID-19 symptoms begin

Individuals age 28 days and older at high risk for progression to severe COVID-19.

Best option for patients who are unable to get Paxlovid due to drug-drug interaction. However, it requires insurance coverage and is not widely available at this time.

Currently only available at selected facilities in Maine, primarily for patients under 12 years old.

Consider for eligible patients who are hospitalized for a non-COVID-19 cause if Paxlovid is not available in the inpatient setting or if oral access is unavailable.

FDA: Veklury (remdesivir) EUA Fact Sheet for Healthcare Providers (PDF)

FDA: Veklury (remdesivir) Fact Sheet for Parents, and Caregivers (PDF)

Bebtelovimab (IV)

  • IV therapy (single dose)
  • Start within 0–7 days after COVID-19 symptoms begin

Individuals 12+ years old at high risk for progression to severe COVID-19.

Best pick for patients who are unable to get Paxlovid due to drug-drug interaction (or severe kidney or liver disease or other concern) and have access to an IV infusion site.

FDA: bebtelovimab EUA Fact Sheet for Healthcare Providers (PDF)

FDA: bebtelovimab EUA Fact Sheet for Patients, Parents, and Caregivers (PDF)

Lagevrio(molnupiravir) (PO)

  • Oral therapy (5 days)
  • Start within 0–5 days after COVID-19 symptoms begin

Individuals 18+ years old at high risk for progression to severe COVID-19.

Best pick for patients who are unable to get Paxlovid due to drug-drug interaction or severe kidney or liver disease, and who do NOT have access to an IV infusion site. Lower effectiveness than the other three therapies.

FDA: Lagevrio (molnupiravir) EUA Fact Sheet for Healthcare Providers (PDF)

FDA: Lagevrio (molnupiravir) EUA Fact Sheet for Patients, Parents, and Caregivers (PDF)

Paxlovid prescription best practices

Prescribers writing prescriptions for Paxlovid should include the dispense-by date (i.e., within 5 days of the symptom onset date) and are encouraged to include information about the patient’s renal function and a statement that the patient’s medication list has been reviewed/reconciled. For further information, refer to FDA’s PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers (PDF).

Essential elements of a Paxlovid prescription

  • Numeric dose of each active ingredient within PAXLOVID
  • Dispense-by date (i.e., within 5 days of symptom onset)
  • Optional: Renal function
  • Optional: Medication list reviewed/reconciled

Strategies for conserving bebtelovimab supply

NIH COVID-19 treatment guidelines recommend Paxlovid as the first-line therapy for outpatient treatment of COVID-19, with remdesivir as second-line therapy. For patients who cannot get Paxlovid or remdesivir, either bebtelovimab or molnupiravir may be used. Limited clinical trial data suggest that bebtelovimab is as effective as Paxlovid or remdesivir, however it should not be the preferred therapy for most patients.

Additionally, as of June 2022, there is a strong possibility that the supply of monoclonals will end within weeks to months. For this reason, Maine CDC is providing this information describing situations in which bebtelovimab is an appropriate choice for treatment of COVID-19, and also those situations where it has been used in recent weeks in ways that should be avoided if Paxlovid or remdesivir can be used instead.

One best practice in use in many facilities is to employ a bebtelovimab referral form that requires the provider to describe the reason why Paxlovid (or remdesivir) could not be used instead for that patient.

Common situations where bebtelovimab is appropriate for use

  • Patients presenting at 6-7 days after symptom onset
  • Drug-drug interactions that cannot be addressed safely
  • GFR <30 (i.e., renal insufficiency too extreme to dose-adjust Paxlovid)
  • Swallowing issues (including severe throat pain from COVID-19)
  • Concerns over loss to follow-up or inability to complete Paxlovid course

Common situations where bebtelovimab is questionable (and possibly avoidable)

  • Default treatment option for pregnancy
  • Unable to assess renal function for Paxlovid
  • Drug-drug interactions “too complicated” for provider to navigate
  • Patient preference (heard that mAb is better, or prior experience)
  • Provider preference (without medical/behavioral rationale)
  • Patients unwilling to risk side-effects from Paxlovid (rebound/isolation)

Patients at High, Higher, and Highest Risk for Severe Disease

Healthcare providers should offer treatment to older adults and others at high risk for progression to severe disease. Treatment of mild/moderate COVID-19 is the standard of care for eligible patients. The following information, based on analysis of Maine’s COVID-19 cases, hospitalizations, and deaths in early 2022 (the Omicron wave), describes patients at high, higher, and highest risk for severe disease. All of these patients are eligible to receive treatment if they have COVID-19 symptoms and a positive test. This information may be helpful in guiding provider behavior related to patient outreach prior to illness onset.

Category Groups Action

High Risk for Severe Disease

All adults age 40 years and older

People with certain underlying conditions1 placing them at higher risk for severe COVID-19 disease

If mild or moderate COVID-19 symptoms and positive direct test, offer outpatient treatment

Higher Risk for Severe Disease

Unvaccinated2, 65+ years

Vaccinated2, 65+ years, with 1+ risk factors1

Unvaccinated2 or vaccinated2, with 2+ risk factors1

Residing in a congregate facility3

If mild or moderate COVID-19 symptoms and positive direct test, offer outpatient treatment

Highest Risk for Severe Disease

Moderately/Severely Immunocompromised4

Unvaccinated1 or Vaccinated1, 75+ years

Unvaccinated1, 50+ years, with 1+ risk factors2

Unvaccinated1, Pregnant5

If mild or moderate COVID-19 symptoms and positive direct test, offer outpatient treatment

  • 1 Some of the most important Underlying Medical Conditions Associated with High Risk for Severe COVID-19 include cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, immunocompromising conditions or receipt or immunosuppressive medications, obesity (BMI ≥30), pregnancy, sickle cell disease.
  • 2 Unvaccinated refers to someone who has not received 2 doses of an mRNA vaccine or 1 dose of the J&J vaccine. Vaccinated refers to someone who received 2 doses of an mRNA vaccine or 1 dose of the J&J vaccine. Vaccinated individuals who have not received a vaccine booster dose are likely at higher risk for severe disease than those who are boosted.
  • 3 Persons living in nursing homes, assisted living facilities, jails, prisons, and homeless shelters who do not meet higher-level criteria.
  • 4 Moderately or Severely Immunocompromised People include people who have been receiving active cancer treatment for tumors or cancers of the blood, received an organ transplant and are taking medicine to suppress the immune system, received a stem cell transplant within the last 2 years or taking medicine to suppress the immune system, moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome), advanced or untreated HIV infection, or active treatment with high-dose corticosteroids or other drugs that suppress the immune response.
  • 5 COVID-19 patients who are pregnant, or were recently pregnant, are more likely to get very sick from COVID-19 compared to people who are not pregnant.

Locations in Maine that Test, Assess, Dispense, and Treat

Information about how patients can access treatment is available on the COVID Treatment in Maine webpage, including pharmacies that dispense oral drugs and hospitals, clinics, urgent care centers, and pharmacies that test, assess, and treat with oral and IV drugs. Some locations offer telemedicine and/or home delivery services.

Federal Allocation of COVID-19 Treatments to Maine

COVID-19 treatments have been purchased by the U.S. Government and distributed to states.

As of April 11–17, 2022, the amount of each medication allocated to Maine is:

  • Paxlovid (nirmatrelvir/ritonavir): 420 treatment courses
  • Bebtelovimab: 205 treatment courses
  • Lagevrio (molnupiravir): 168 treatment courses

The most recent allocations by state are available from the ASPR website.

Veklury (remdesivir) is also available for outpatient treatment in some healthcare facilities in Maine. It is not supplied by the U.S. Government. As of May 2022, Veklury is only available at Maine Medical Center, Eastern Maine Medical Center, and Lincoln Hospital. (This will be updated with other available locations.)

Clinical Resources for COVID-19 Treatment

CDC provides information about Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19 (Information for Healthcare Professionals) that can be used to determine who is considered at high risk for severe disease, for the purposes of treatment. The following figures highlight the sharp rise in risk of death by age >40 years, and the sharp rise in risk of death with multiple comorbid conditions:

Adapted from Sources:

  • Kompaniyets L, Pennington AF, Goodman AB, Rosenblum HG, Belay B, Ko JY, et al. Underlying Medical Conditions and Severe Illness Among 540,667 Adults Hospitalized With COVID-19, March 2020–March 2021. To learn more, visit the Preventing Chronic Disease article: https://www.cdc.gov/pcd/issues/2021/21_0123.htm
  • Pennington AF, Kompaniyets L, Summers AD, Danielson ML, Goodman AB, Chevinsky JR, Preston LE, Schieber LZ, Namulanda G, Courtney J, Strosnider HM, Boehmer TB, Mac Kenzie WR, Baggs J, Gundlapalli AV, Risk of Clinical Severity by Age and Race/Ethnicity Among Adults Hospitalized for COVID-19—United States, March–September 2020, Open Forum Infectious Diseases, Volume 8, Issue 2, February 2021. To learn more, visit: https://doi.org/10.1093/ofid/ofaa638

Source: Kompaniyets L, Pennington AF, Goodman AB, Rosenblum HG, Belay B, Ko JY, et al. Underlying Medical Conditions and Severe Illness Among 540,667 Adults Hospitalized With COVID-19, March 2020–March 2021. To learn more, visit the Preventing Chronic Disease article: https://www.cdc.gov/pcd/issues/2021/21_0123.htm

NIH COVID-19 treatment guidelines provide the key recommendations regarding treatment options, including the Therapeutic Management of Nonhospitalized Adults With COVID-19.

  • a For a list of risk factors, see the CDC webpage Underlying Medical Conditions Associated With Higher Risk for Severe COVID-19 and the Patient Prioritization for Treatment section below.
  • b Ritonavir-boosted nirmatrelvir has significant drug-drug interactions. Clinicians should carefully review a patient’s concomitant medications and evaluate potential drug-drug interactions.
  • c If a patient requires hospitalization after starting treatment, the full treatment course can be completed at the health care provider’s discretion.
  • d Administration of remdesivir requires 3 consecutive days of IV infusion.
  • e Bebtelovimab is active in vitro against all circulating Omicron subvariants, but there are no clinical efficacy data from placebo-controlled trials that evaluated the use of bebtelovimab in patients who are at high risk of progressing to severe COVID-19. Therefore, bebtelovimab should be used only when the preferred treatment options are not available, feasible to use, or clinically appropriate.
  • f Molnupiravir has lower efficacy than the preferred treatment options. Therefore, it should be used only when the preferred options are not available, feasible to use, or clinically appropriate.
  • g There is currently a lack of safety and efficacy data on the use of this agent in outpatients with COVID-19; using systemic glucocorticoids in this setting may cause harm.
  • h These individuals should receive oximetry monitoring and close follow-up through telehealth, visiting nurse services, or in-person visits.
  • i Provide an advanced level of home care, including supplemental oxygen (whether patients are receiving oxygen for the first time or are increasing their baseline oxygen requirements), pulse oximetry, laboratory monitoring, and close follow-up through telehealth, visiting nurse services, or in-person visits.
  • j See Therapeutic Management of Hospitalized Adults With COVID-19.

Key: AE = adverse event; CDC = Centers for Disease Control and Prevention; ED = emergency department; IV = intravenous; the Panel = the COVID-19 Treatment Guidelines Panel; PO = orally

Click here for the latest NIH materials for outpatient treatment.

HHS/ASPR has developed the following clinical decision aid for selecting from available treatment options.

Outpatient Therapeutics Ages 12+

Click here (PDF) to get the latest version along with clickable links.

Outpatient Therapeutics Pediatric

Click here (PDF) to get the latest version along with clickable links.

Additional Information

Additional information is available in the following Health Advisories sent via the Health Alert Network.

Patient Information

Many people who get infected with COVID-19 and are at high risk for severe disease do not learn about treatment options in time to access early treatment. Additionally, the atypical routes to access these medications and other considerations such as transportation and insurance remain substantial barriers. To aid in sharing information with patients about the availability of these medicines, we created these simple graphics which can be printed, posted, and handed out to patients.

COVID-19 Treat Early
COVID-19 Treat Early Conditions

Download and print Don't Delay: Test Early, Treat Early (PNG) and Don't Delay: Who Is Considered High Risk? (PNG) to post and hand out to patients.