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Mpox information for health care providers

What providers need to know about mpox (formerly called monkeypox) clinical guidance and smallpox/mpox vaccine (JYNNEOS™), and Tecoviromat (TPOXX) treatment administration, eligibility, and availability in Massachusetts.
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Clinical guidance

Vaccination

JYNNEOS vaccine administration

The JYNNEOS vaccine is shipped in 100 dose boxes containing 20 vials in each It is assumed that dose will be given intradermally as noted below, thus making each vial a 5-dose multi-dose vial.

Direct shipments of JYNNEOS vaccine are supplied to providers frozen and can be kept in a freezer until the labeled expiration date on the box. Once the JYNNEOS vaccine is thawed it must be refrigerated between 2-8 degrees C and is viable for up to 8 weeks based on information provided by the manufacturer.

On August 9, the U.S. Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) released an Emergency Use Authorization (EUA) allowing an alternative dose vaccination regimen in people 18 years and over and allowing the use of the JYNNEOS vaccine in individuals younger than 18 years.

The original JYNNEOS approval included the use of two 0.5 mL doses administered subcutaneously (under the skin). The alternative regimen allows the use of two lower doses, 0.1 mL of vaccine administered intradermally (into the skin), which is currently the preferred method of administration in attempt to sustain vaccine supply. Providers administering JYNNEOS vaccine began utilizing this alternative dose vaccination regimen as early as August 18, 2022.

Eligibility

As of October 3, 2022, vaccination will be available to individuals who live or work in Massachusetts and meet the CDC’s current eligibility criteria, which have recently expanded to include individuals at potential risk for mpox in addition to those with possible recent exposure to an individual with mpox.

Persons eligible for post-exposure vaccination (PEP) include: 

  • 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

         In addition, CDC now allows for pre-exposure vaccination (PrEP) of persons at risk for mpox which includes:

  • Gay, bisexual, and other men who have sex with men, and transgender or nonbinary people (including adolescents who fall into any of 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

When an individual at risk requests vaccine, they will not be asked which of these criteria applies. It is sufficient to say that they consider themselves to be at risk for mpox.

Additional CDC information:

Availability

Administration of JYNNEOS is available at any one of the designated health care locations listed below. Healthcare providers are responsible to perform exposure assessment to confirm eligibility prior to scheduling an appointment for a vaccine. Vaccination sites designated below may also offer vaccination on a walk-in basis (no appointment required).

Please contact sites first to confirm that walk-in vaccinations are offered.

For a list of mpox vaccine providers and appointment information, visit How to obtain vaccine.

ACAM2000

Please note that CDC has also made available the live replicating smallpox vaccine ACAM2000. This vaccine is available in larger quantities but has a number of characteristics that make it unsuitable for use in the current context, including considerably greater risk to the recipient compared with JYNNEOS. Local health departments and providers are not currently requesting ACAM2000.

Treatment

Tecovirimat (TPOXX)  

Currently there is no treatment approved specifically for monkeypox virus infections. However, antivirals developed for use in patients with smallpox may prove beneficial against monkeypox. 

Tecovirimat (also known as TPOXX or ST-246) is FDA-approved for the treatment of human smallpox disease caused by Variola virus in adults and children. However, its use for other orthopoxvirus infections, including mpox, is not approved by the FDA. CDC holds a non-research expanded access Investigational New Drug (EA-IND) protocol that allows for the use of tecovirimat for primary or early empiric treatment of non-variola orthopoxvirus infections, including mpox, in adults and children of all ages.  Clinicians may obtain and provide TPOXX for their patients by participating in the CDC EA-IND process. 

Many people infected with monkeypox virus have a mild, self-limiting disease course in the absence of specific therapy. However, the prognosis for monkeypox depends on multiple factors, such as previous vaccination status, initial health status, concurrent illnesses, and comorbidities among others. For more information, see the CDC’s Interim Clinical Guidance for the Treatment of Mpox.

Learn more about the CDC’s required EA-IND protocol and requirements on CDC website.

DPH has supplies of TPOXX available for Massachusetts providers, in both oral and intravenous form from the U.S. Department of Health and Human Services’ Strategic National Stockpile. This supply may be used where, after review of CDC clinical criteria, a provider believes it is clinically appropriate to order TPOXX to treat a patient. See further information on the processes for obtaining TPOXX  and reporting TPOXX administration.

JYNNEOS vaccine ordering & compliance

Bavarian Nordic, the manufacturer of the JYNNEOS vaccine, has opened ordering of the vaccine through commercial wholesalers. The commercialization of the JYNNEOS product (NDC: 50632-0001-02) changes how state-supplied doses are ordered and administration eligibility. 

Effective July 1, 2024, state supplied JYNNEOS doses (NDC: 50632-0001-02) may only be administered to the following patient populations:  

  • Individuals who are 18 years of age, irrespective of insurance status, or
  • Adults 19 years of age and older who are uninsured/underinsured. 

This policy applies to both existing state-supplied doses of JYNNEOS vaccine currently in your inventory, and to any JYNNEOS doses ordered from DPH on or after 7/1/2024. In addition, starting on 7/1/2024 only public provider sites can continue ordering doses of vaccine from DPH for the populations noted above.

Place orders for privately purchased JYNNEOS vaccine through your organization’s established private ordering mechanisms (most pharmaceutical distributors carry the vaccine). Providers need to privately purchase JYNNEOS doses for insured adult patients (19 years or older) and begin billing insurance for those insured adult patients receiving JYNNEOS vaccines at their site. The transition to private purchase for insured clients/patients should occur well before the 7/1/24 to ensure there are no gaps in vaccine availability. As a reminder, cost-sharing and out-of-pocket charges to patients for any vaccines including JYNNEOS are not permittable under federal guidelines.

For public provider sites be sure to continue ordering doses form DPH to meet the anticipated need for uninsured/underinsured clients/patients. As a reminder, JYNNEOS doses are not orderable via the MIIS at the current time and must be ordered by contacting the Vaccine Management Unit directly.  

JYNNEOS vaccine administration

The JYNNEOS vaccine is shipped in conditioned boxes containing 20 vials in each. If administered subcutaneously, each vial is considered a single dose vial. If administer intradermally, each vial is considered a five dose multi-dose vial of vaccine.

Direct shipments of JYNNEOS vaccine are supplied to providers frozen and can be kept in a freezer until the labeled expiration date on the box. Once the JYNNEOS vaccine is thawed it must be refrigerated between 2-8 degrees C and is viable for up to 8 weeks based on information provided by the manufacturer.

The standard regimen for JYNNEOS involves a subcutaneous (SQ) route of administration with an injection volume of 0.5mL. An alternative regimen involving intradermal (ID) administration with an injection volume of 0.1mL may be used under an Emergency Use Authorization (EUA) in people 18 years and over.

  • Both the standard (0.5mL SQ) and the alternative (0.1mL ID) regimen have been found to be effective for mpox prevention.
  • There is currently adequate supply of JYNNEOS vaccine. Therefore, clinicians can preferentially administer JYNNEOS via the subcutaneous route. 

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