Mpox Resources for Healthcare Providers

Quick Links to Mpox Topics

Last updated: March 3, 2023

Clinical Presentation

Mpox has a classic clinical presentation that has been seen for many years in endemic countries. Mpox cases in the 2022 global outbreak appear somewhat different in terms of the distribution of lesions and the lack of prodrome.

Classic Presentation

  • Fever and other prodromal symptoms (e.g., chills, lymphadenopathy, malaise, myalgias, or headache) can occur before rash but may occur after rash or not be present at all.
    • Respiratory symptoms (e.g., sore throat, nasal congestion, or cough) can occur.
  • Rectal symptoms (e.g., purulent or bloody stools, rectal pain, or rectal bleeding) have been frequently reported in the current outbreak.
  • Lesions:
    • Are firm or rubbery, well-circumscribed, deep-seated, and often develop umbilication (resembles a dot on the top of the lesion).
    • Are often described as painful until the healing phase when they become itchy (crusts).
    • Typically develop simultaneously and evolve together on any part of the body.
    • Progress through four stages (macular, papular, vesicular, pustular) before scabbing over and desquamation.

During the 2022 global outbreak:

  • Lesions:
    • Often occur in the genital and anorectal areas or in the mouth.
    • Are not always disseminated across many sites on the body.
    • May be confined to only a few lesions or only a single lesion.
    • May not always appear on palms and soles.
  • The illness typically lasts 2-4 weeks.

Transmission can occur:

  • Through close, personal, often skin-to-skin contact during sexual activity with one or more mpox lesions on the skin or mucosal surface. This has been the primary mode of transmission during the 2022 U.S. outbreak.
  • From injury with a sharp instrument used to sample skin lesions.
  • During pregnancy from the infected pregnant person to their fetus.
  • From infected animals, either by being scratched or bitten by the animal or by preparing or eating meat or using products from an infected animal.
  • More information is available here.

The incubation period is 3-17 days.

Infectiousness: A person with mpox is infectious when symptomatic until after all the scabs on the skin have fallen off and a fresh layer of intact skin has formed. Additionally, presymptomatic transmission is possible: some people with mpox can infect others 1-4 days prior to symptom onset. There is no evidence of asymptomatic transmission.

Healthcare Infection Control

Please refer to U.S. CDC's Infection Prevention and Control of Mpox in Healthcare Settings.

Testing

Clinicians should take a thorough patient history, including a sexual history. A thorough physical exam should also be performed and should include examination of the skin and all mucous membranes (e.g., oral, genital, anal) for evidence of lesions. Consider testing patients presenting with a new characteristic rash or lesions or if the patient meets epidemiologic criteria and there is a clinical suspicion for mpox.

Epidemiologic criteria refers to a person who, within 21 days of illness onset:

  • Reports having contact with a person or people with a similar appearing rash or who received a diagnosis of confirmed or probable mpox, OR
  • Had close or intimate in-person contact with individuals in a social network experiencing mpox activity, this includes men who have sex with men (MSM) who meet partners through an online website, digital application ("app"), or social event (e.g., a bar or party), OR
  • Traveled outside the U.S. to a country with confirmed cases of mpox or where mpox virus is endemic, OR
  • Had contact with a dead or live wild animal or exotic pet that is an African endemic species or used a product derived from such animals (e.g., game meat, creams, lotions, powders, etc.)

Skin lesion material, including swabs of lesion surface, exudate, or lesion crusts are the recommended specimen types for laboratory testing of mpox virus specimens. Specimens should be obtained from lesions (including those inside the mouth, anus, or vagina), if accessible. Unroofing or aspiration of lesions (or otherwise using sharp instruments for mpox testing) before swabbing is not necessary, nor recommended due to the risk for sharps injury.

Specimen Type

  • Patients can be tested for mpox virus via swabs of lesions including those inside the mouth, anus, or vagina.
  • No saliva or blood tests are available at this time.

Laboratories and Specimen Submission

  • Maine CDC encourages all healthcare providers and facilities to utilize commercial testing.
  • The specimen type and handling instructions vary by laboratory.
  • Personnel who collect specimens should use personal protective equipment (PPE) in accordance with recommendations for healthcare settings.
  • When possible, use a plastic, sterile, leak-proof container rather than glass materials for specimen collection.
  • Specimens can be sent to Maine's Health and Environmental Testing Laboratory (HETL).
  • Maine CDC strongly encourages clinicians evaluating persons for mpox to also evaluate and screen for STIs, including but not limited to, HIV, syphilis, gonorrhea (GC), and chlamydia (CT) per the 2021 CDC STI Treatment Guidelines. Collect samples for GC/CT testing from all anatomical locations where sexual activity has occurred. Additionally, consider offering preventative care, HIV care, HIV PrEP to eligible persons. In a recent study among 1,969 persons with mpox during May 17–July 22, 2022, in eight U.S. jurisdictions, 38% had HIV infection, and 41% had an STI in the preceding year.

Treatment

Who to Treat

Treatment for many patients with mpox includes early initiation of supportive care and for many, pain management. Genital and mucosal lesions can be associated with pain out of proportion to their appearance. Uncontrolled pain in patients with mpox has led to hospitalization; in a multinational report of patients with mpox, 13% of patients were admitted to the hospital, 30% of whom were admitted for pain management.

While there are currently no treatments specifically approved for mpox, therapeutics developed for patients with smallpox have been successfully used during the 2022 U.S. mpox outbreak. The prognosis for patients with mpox depends on multiple factors, such as previous vaccination status, health status, concurrent illnesses, and comorbidities, among others.

Beyond supportive care and pain management (which are appropriate for many patients), consider additional treatment for patients:

  1. With the following clinical manifestations:
    • Severe disease, such as hemorrhagic disease; a large number of lesions; necrotic lesions; severe lymphadenopathy; involvement of multiple organ systems and associated comorbidities (for example, pulmonary involvement with nodular lesions; sepsis; encephalitis; myocarditis; ocular or periorbital infections); or other conditions requiring hospitalization
    • Involvement of anatomic areas which might result in serious sequelae that include scarring or strictures: these include lesions directly involving the pharynx; penile foreskin, vulva, vagina, urethra, or anorectum with the potential for causing strictures or requiring catheterization; anorectal lesions interfering with bowel movements (for example, severe pain); and severe infections (including secondary bacterial skin infections), especially those that require surgical intervention such as debridement.
  2. Who are at high risk of severe disease:
    • People currently experiencing severe immunocompromise due to conditions such as advanced or poorly-controlled human immunodeficiency virus (HIV), leukemia, lymphoma, generalized malignancy, solid organ transplantation, therapy with alkylating agents, antimetabolites, radiation, tumor necrosis factor inhibitors, high-dose corticosteroids, being a recipient of a hematopoietic stem cell transplant <24 months post-transplant or ≥24 months but with graft-versus-host disease or disease relapse, or having autoimmune disease with immunodeficiency as a clinical component. Read more here.
    • Pediatric populations, particularly patients younger than 1 year of age.
    • Pregnant or breastfeeding people.
    • People with a condition affecting skin integrity: conditions such as atopic dermatitis, eczema, burns, impetigo, varicella zoster virus infection, herpes simplex virus infection, severe acne, severe diaper dermatitis with extensive areas of denuded skin, psoriasis, or Darier disease (keratosis follicularis).

Treatments

Tecovirimat (TPOXX) should be considered for patients who have any of the above-mentioned clinical manifestations or who are at high risk of severe disease. TPOXX is an antiviral medication, available as a pill or injections for intravenous (IV) administration, approved for the treatment of smallpox in adults and children. A clinical trial focused on safety in healthy people without mpox virus showed the drug had an acceptable safety profile; the effectiveness of TPOXX was not studied in this trial. Data are not available on the effectiveness of TPOXX in treating mpox infections in people, but studies using a variety of animal species have shown that TPOXX is effective in treating disease caused by orthopoxviruses, like mpox.

How to Obtain TPOXX

Currently there are two methods for obtaining TPOXX, the first one being the preferred method if the patient voluntarily participates:

  1. Through the Study of Tecovirimat for Human Mpox Virus (STOMP) which is a double-blind phase 3 clinical trial sponsored by the National Institutes of Health to evaluate TPOXX for the treatment of human mpox infection. Adults and children with mpox infection in the United States are eligible. Remote enrollment is now available.
  2. Through the U.S. CDC's Expanded Access Investigational New Drug Protocol (EA-IND) (also called compassionate use) process. This allows for the use of stockpiled TPOXX to treat mpox.
    • There are requirements for healthcare providers prescribing TPOXX using the EA-IND, which were updated on October 24, 2022.
      • New providers and affiliated facilities can now register online as participating providers/sites and can submit the required forms. Providers who have returned required IND forms prior to the online registry transition are grandfathered in as participating providers under the EA-IND.
      • Any providers with valid email addresses on record should have received emails providing them access to the electronic Patient Intake and Clinical Outcome forms on October 25, 2022.
      • Any questions about the registry and transition to electronic tecovirimat IND Patient Intake and Clinical Outcome forms can be directed to CDC IMS TPOXX IND (eocevent477@cdc.gov).
      • Healthcare providers will be responsible for completing a number of required and optional forms found here.
    • TPOXX is available at locations across Maine.

Patients can start TPOXX upon receipt of the medication and after providing informed consent. Forms requested under the EA-IND can all be sent to U.S. CDC using the online registry after treatment begins.

A positive mpox test is not needed prior to initiation of TPOXX. TPOXX is provided at no cost by the federal government. Patients should not be charged, but clinicians may bill for the encounter.

Additional Treatments:

Additional treatments can be considered as additive or alternative therapy for treating mpox in persons experiencing certain situations, including, but not limited to:

  • Severe disease at initial presentation to healthcare or at high risk for progression to severe disease.
  • Clinically significant disease progression while receiving TPOXX or who develop recrudescence (initial improvement followed by worsening) of disease after an initial period of improvement on TPOXX.
  • Severe immunocompromise.
  • Those for whom there is concern for the development of resistance to TPOXX.
  • Those who are unable to receive TPOXX.

Brincidofovir (CMX001 or Tambexa)

  • Is an antiviral medication approved by the FDA (PDF) for the treatment of human smallpox disease in adult and pediatric patients, including neonates. It has shown to be effective against orthopoxviruses in in vitro and animal studies. Data are not available on the effectiveness of brincidofovir in treating mpox in people.
  • It can be considered for people with positive mpox test results who:
    • Have severe disease OR are at high risk for progression to severe disease,
    • AND meet either of the following:
      1. Experience clinically significant disease progression while receiving TPOXX or develop recrudescence (initial improvement followed by worsening) of disease after an initial period of improvement on TPOXX, OR
      2. Are otherwise ineligible or have a contraindication for oral or intravenous TPOXX.
    • To obtain brincidofovir, clinicians need to submit an e-IND request to FDA by email (DDI.EIND@fda.hhs.gov) or phone (301-796-3400 or 1-855-543-3784) during normal busienss hours (8 am-4:30 pm ET M-F). During after hours, call the FDA Emergency Coordinator at 1-866-300-4374 or 301-796-8240 or email CDER-EIND@fda.hhs.gov and call the CDER Emergency Coordinator at 301-796-9900.

Vaccinia Immune Globulin Intravenous (VIGIV)

  • VIGIV is licensed by FDA (PDF) for the treatment of complications due to vaccinia vaccination; it is not approved for treatment of mpox.
  • U.S. CDC holds an EA-IND protocol (PDF) that allows the use of stockpiled VIGIV for the treatment of orthopoxviruses (including mpox) in an outbreak.
  • Data are not available on the effectiveness of VIGIV in treating mpox in people. VIGIV can be considered for prophylactic use in an exposed person with severe immunodeficiency in T-cell function for which smallpox or mpox vaccination following exposure to mpox is contraindicated.
  • VIGIV is only available upon request to U.S. CDC on a case-by-case basis. Contact the U.S. CDC Clinical Consultation Team by email (ecoevent482@cdc.gov during business hours, or for urgent clinical situations, contact the CDC Emergency Operations Center (770-488-7100). An informed consent (PDF) must be obtained prior to administration. The remaining VIGIV IND fillable forms will be provided.

Cidofovir (Vistide)

  • Is an antiviral medication approved by the FDA (PDF) for the treatment of cytomegalovirus (CMV) retinitis in patients with Acquired Immunodeficiency Syndrome (AIDS), and is commercially available as an injection.
  • Data are not available on the effectiveness of cidofovir in treatment of mpox in people, but it has shown to be effective against orthopoxviruses in in vitro and animal studies.
  • Brincidofovir, a prodrug of cidofovir, may have an improved safety profile over cidofovir.

If you are interested in using any of these additional treatments, please first contact Maine CDC at 1-800-821-5821.

For more information and updates on treatments, see U.S. CDC's Treatment Information for Healthcare Professionals.

Patient Education

  • Provide information on JYNNEOSTM vaccine
  • Talk with your patients about safer sex practices
  • Provide guidance on isolation to your patients who have mpox. Ideally, people with mpox would remain in isolation for the duration of illness, which typically lasts two to four weeks. However, if a person with mpox is unable to remain fully isolated throughout the illness, U.S. CDC has recommendations on how to reduce transmission

Vaccination

JYNNEOSTM vaccine is the primary vaccine being used in the U.S. during this outbreak; it is approved for the prevention of smallpox and mpox.

  • People can be vaccinated as pre-exposure and post-exposure prophylaxis.
    • For post-exposure prophylaxis, the U.S. CDC recommends initiating vaccination within 4 days following the date of exposure for the best chance to prevent onset of the disease. If initiated between 4-14 days following exposure, vaccination might be less effective (i.e., it could reduce the severity of symptoms but it is not expected to prevent symptom onset). Benefits might still outweigh risks when administering vaccine more than 14 days after exposure in some clinical situations (e.g. for a severely immunosuppressed person with a recent sex partner confirmed to have mpox). Vaccination is not expected to provide benefit if it is given after onset of signs or symptoms of mpox begin.
  • Preliminary JYNNEOSTM vaccine effectiveness estimates against medically attended mpox disease in the U.S. are now available which demonstrate that JYNNEOSTM is effective at reducing the risk of mpox disease, with two doses providing the best protection, regardless of how (intradermal vs. subcutaneous) the vaccine was administered.
  • Limited data on performance of JYNNEOSTM vaccine in the current outbreak are becoming available. Across 32 U.S. jurisdictions, among males aged 18-49 years eligible for JYNNEOSTM vaccination, mpox incidence was 14 times as high among unvaccinated males compared with those who had received a first vaccine dose ≥14 days earlier.
  • Peak immunity is expected to be reached 14 days after the second dose of JYNNEOSTM vaccine, however the duration of immunity is unknown.
  • Current surveillance supports JYNNEOSTM vaccine safety. In a recent study, the vaccine safety profile was found to be consistent with prelicensure studies and the most common adverse events were nonserious and included infection site reactions.

Vaccine Eligibility

Mpox vaccination should be offered to:

  • People who had known or suspected exposure to someone with mpox
  • People who had a sex partner in the past 2 weeks who was diagnosed with mpox
  • Gay, bisexual, and other men who have sex with men, and transgender or nonbinary people (including adolescents who fall into any of the these categories) who, in the past 6 months, have had:
    • A new diagnosis of one or more sexually transmitted diseases (e.g., chlamydia, gonorrhea, syphilis); or
    • More than one sex partner.
  • People who have had any of the following in the past 6 months:
    • Sex at a commercial sex venue; or,
    • Sex in association with a large public event in a geographic area where mpox transmission is occurring.
    • Sex in exchange for money or other items
  • People who are sexual partners of people with the above risks.
  • People who anticipate experiencing any of the above scenarios.
  • People with HIV infection or other causes of immunosuppression who have had recent or anticipate potential mpox exposure.
  • People who work in settings where they may be exposed to mpox:
    • People who work with orthopoxviruses in a laboratory

Contraindications for use of JYNNEOSTM: Individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of JYNNEOSTM should not be vaccinated. Please refer to an allergist-immunologist for assessing risks and benefits of administering a dose. Talk to your healthcare provider if you have a history of an allergic reaction to the antibiotics gentamicin or ciprofloxacin, or chicken or egg protein.

A list of locations offering vaccine is available on Maine CDC's mpox website.

Vaccination is also available to laboratory workers who work with specimens that could contain mpox: Orthopox Vaccine Guidance for Persons at Risk of Occupational Exposure

Vaccine Administration

Dosing intervals:

  • JYNNEOSTM vaccine is licensed as a series of two doses.
  • Recommended interval: The second dose of JYNNEOSTM vaccine should be given 28 days after the first dose and up to 7 days later (i.e., up to 35 days after the first dose).
  • Minimum interval: The vaccine manufacturer advises against giving the second dose early. However, based on ACIP’s general best practices, a dose may be administered a minimum of 24 days after the first dose.
  • Maximum interval: If the second dose is not administered during the recommended interval, it should be administered as soon as possible based on ACIP’s general best practices.

    There is no need to restart or add doses to the series if there is an extended interval between doses.

Dosing regimes:

  • The FDA-approved standard regimen is a 0.5mL dose administered subcutaneously.
  • Under an Emergency Use Authorization, an alternative regimen of 0.1 mL administered intradermally may be used for adults aged ≥18 years. The alternative regimen safely provides a similar immune response against mpox as the approved two-dose subcutaneous regimen. Results from a clinical study showed that the lower intradermal dose was immunologically non-inferior to the standard subcutaneous dose.
  • Healthcare providers can decide whether to offer the intradermal or subcutaneous regimen based on balancing optimal vaccine use and acceptance, feasibility of administration, and available vaccine supply.

Coadministration:

  • There are no data on administering JYNNEOSTM vaccine at the same time as other vaccines. Because JYNNEOSTM is based on a live, attenuated non-replicating orthopoxvirus, JYNNEOSTM typically may be administered without regard to timing of other vaccines. This includes simultaneous administration of JYNNEOSTM and other vaccines on the same day, but at different anatomic sites if possible. However, there are additional considerations if administering a COVID-19 vaccine; see details here.
  • Currently, there are no data on administering JYNNEOSTM vaccine at the same time as the tuberculin skin test (TST). If a delay in the TST would cause substantial burden (e.g., preventing a person from working because of pre-employment screening policies) then the TST should not be delayed. If delays in the TST will not cause substantial burden, a delay of at least 4 weeks after JYNNEOSTM vaccination is preferred. See details here.

JYNNEOSTM Emergency Use Authorization Factsheets:

U.S. CDC JYNNEOSTM Vaccine webpage

Clinician Informational Sessions

PDFs from recent sessions:

Reporting to Maine CDC

Mpox is a reportable condition in the State of Maine.

  • Any confirmed case of mpox is immediately reportable to Maine CDC within 24 hours; and
  • All mpox or non-variola orthopoxvirus test results (positive or negative) are reportable to Maine CDC within 24 hours.

Confirmed cases should be reported immediately to Maine CDC by phone at 800-821-5821.

For more information:

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