Mpox Provider and Partner FAQs and Resources

New information about pediatric and intradermal vaccinations (August 11, 2022)

General

Where can I find information about the current MPV outbreak?

See Washington Department of Health updates on the outbreak in Washington state.

See CDC updates on the outbreak in the U.S.

How can I reduce stigma when talking about monkeypox?

Anyone can be infected with MPV, which is a public health issue important to everyone. See CDC guidance on how you can reduce stigma in MPV communication and engagement.

Diagnosis

What are the clinical features of MPV disease (monkeypox)? What does the rash look like? 

See the CDC Clinical Recognition webpage for information on diagnosing MPV disease including photos of rashes.

Is there a lab test to determine if my patient has MPV infection?

Yes, MPV infection is typically diagnosed through a PCR test performed on a swab of a lesion. Testing is available at commercial and academic clinical laboratories as well as the Washington State Public Health Laboratories (WSPHL). Testing by WSPHL requires approval from the patient’s local health jurisdiction.

If I am testing a patient for MPV, what other testing and treatment should I consider?

In this outbreak, most people who receive MPV testing should also be tested for HIV and other STIs (e.g., syphilis, gonorrhea, chlamydia). Many people who receive MPV testing would also benefit from HIV pre-exposure prophylaxis (PrEP).

I diagnosed my patient with another infection (e.g., syphilis, gonorrhea, chlamydia). Can I assume that they don't have MPV infection?

Co-infections with MPV and STIs have been reported, so the presence of an STI does not rule out MPV infection. If the patient’s clinical presentation is compatible with MPV disease, you should still consider MPV testing. See CDC guidance for further information: See CDC clinical FAQs for further information. 

Is MPV infection a notifiable condition?

Yes, MPV infection is a notifiable condition. You will need to report any cases you diagnose to your local health jurisdiction as soon as they are diagnosed. Find information and forms on DOH’s Notifiable Conditions webpage.

Clinical Considerations

When is someone with MPV disease contagious?

A person with MPV disease is contagious from the first symptom until all the scabs have fallen off and a fresh layer of intact skin has formed. It is possible that people with MPV infection might be contagious prior to symptom onset, or even if they have an entirely asymptomatic infection, but transmission from pre-symptomatic or asymptomatic people has not been documented.

Who is at higher risk for severe MPV disease?

According to the CDC, young children (<8 years of age), people who are pregnant and/or breastfeeding, immunocompromised people, and people with a history of atopic dermatitis or eczema may be at especially increased risk for severe outcomes from MPV disease. Providers should strongly consider antiviral treatment for these populations; see CDC treatment guidance for more information. 

What are the clinical considerations for people living with HIV?

According to the CDC, people with HIV-associated immunosuppression or people with HIV who are not virologically suppressed can be at increased risk of severe MPV disease. See CDC clinical considerations for people living with HIV for more information on treatment and prophylaxis for MPV in people living with HIV.

Which medications can be given to treat MPV disease?

The medication most commonly used in the current outbreak is tecovirimat (TPOXX), which is approved for smallpox and is available for treatment of MPV disease under an expanded access new investigational drug protocol. See CDC treatment guidance for more information about tecovirimat and other treatments.

What are the clinical considerations for pain management for people with MPV disease?

The CDC provides detailed information about pain control including treatments for specific symptoms and lesion sites. 

Patient Advice

What should I do if my patient might have been exposed to someone with MPV disease?

Contact your local health jurisdiction, who can help assess the exposure and determine if post-exposure prophylaxis (vaccination) is recommended. CDC recommends post-exposure prophylaxis be given within four (4) days from the date of exposure in order to prevent onset of the disease. If given between 4-14 days after the date of exposure, vaccination may reduce the symptoms of disease, but may not prevent the disease.

If the patient is asymptomatic, counsel the patient about the symptoms of MPV disease, as well as the need to isolate and contact a healthcare provider if symptoms occur. If the patient is symptomatic, evaluate the patient for MPV disease, and consider MPV testing. If you decide to proceed with MPV testing, advise the patient to isolate at home while the test is pending.

What should I tell a patient with MPV disease about the expected course of illness?

The clinical course of MPV disease is variable. Counsel the patient about potential complications and reasons to seek follow-up care. The duration of symptoms and the contagious period also vary; usually the contagious period lasts for two to four weeks. People with MPV disease are no longer contagious when all the scabs on the skin have fallen off and a fresh layer of intact skin has formed underneath. CDC provides more information on the clinical course of illness.

What advice should I give to my patient with MPV disease about reducing the risk of transmission to others?

CDC provides detailed information on reducing the risk of transmission including steps that people with MPV disease can take, how long they need to isolate, and prevention measures for their home. 

Infection Control

What PPE should be used for health care personnel who enter the room of a person with suspected or confirmed MPV infection?

According to the CDC, healthcare personnel should use a gown, gloves, eye protection, and a NIOSH-approved particulate respirator equipped with N95 filters or higher.

Where can I find information on infection control for MPV in health care settings?

CDC provides detailed information on infection control including patient placement, PPE, waste management, environmental infection control steps, and other topics.

Other Information

Where can I find more clinical guidance on MPV?

See these CDC webpages:

Where can I find more information available about MPV and pets?

We are still learning which species of animals can be infected with MPV. However, it is possible that people with MPV infection could transmit to animals. Patients with MPV infection should be advised to avoid contact with mammals. See the Washington State Guidelines on Monkeypox in Animals for more information.

Vaccine Information

Which vaccine is Washington going to have available for those who are exposed and need vaccination for protection against developing MPV?

At present, DOH is using only JYNNEOS vaccine for both post-exposure prophylaxis and prevention of MPV.  

JYNNEOS is safe to administer to people with HIV and eczema or other exfoliative skin conditions.

Pregnancy and breastfeeding are not contraindications to receiving JYNNEOS. While there are no data in people who are pregnant or breastfeeding, animal data do not show evidence of reproductive harm.

Please see the JYNNEOS Special Considerations (CDC) section for guidance on contraindications and precautions and additional clinical considerations for use of JYNNEOS.

How many doses of JYNNEOS vaccine should individuals who need vaccination receive?

JYNNEOS is administered as two doses delivered 28 days apart. DOH recommends prioritizing the administration of first vaccine doses rather than retaining inventory for second doses. People with moderate and severe immunosuppression should get the second dose as close to the 28-day mark as possible.

Who should receive MPV vaccination?

Outreach to and vaccination of individuals who meet the categories below should be prioritized with vaccine supply limitations.

  • Gay and bisexual men and transgender individuals who have had multiple or anonymous gay, male bisexual, or transgender sex partners in the last 3 months. 
  • People who have used methamphetamine in the last 3 months. 
  • People who have exchanged sex for money, drugs, or other purposes in the past 3 months. 
  • People who have been sexually assaulted, regardless of gender or sexual orientation.
  • People who have had sexual contact or prolonged skin-to-skin exposure with people who were exposed to MPV.

In addition, offer vaccine to known contacts of an MPV case who are identified by public health, as well as presumed contacts who either report that a sex partner in the past 14 days was diagnosed with MPV, or who report multiple sex partners in the past 14 days in a jurisdiction with known MPV.

For more information: Guidelines for JYNNEOS Vaccine Use (PDF).

What age group is JYNNEOS authorized for?

On August 9, 2022, the FDA has granted emergency use authorization for JYNNEOS vaccine to be given to children under 18 years. 

JYNNEOS is already authorized in those ages 18 and older. For questions about vaccinations, contact MonkeypoxClinical@doh.wa.gov.

Sample Consent Form for Minor Vaccination of JYNNEOS (PDF)

When should JYNNEOS be given?

CDC recommends that the vaccine be given within 4 days from the date of exposure to prevent onset of the disease. If given between 4 and 14 days after the date of exposure, vaccination may reduce the symptoms of disease, but may not prevent the infection.

When is someone fully protected after vaccination?

They are fully protected two weeks after the second dose is administered People who get vaccinated should continue to take steps to protect themselves from infection by avoiding close, skin-to-skin contact, including intimate contact, with someone who has monkeypox.

Is the vaccine safe?

JYNNEOS is fully licensed by the U.S. Food and Drug Administration (FDA) and recommended by the CDC’s Advisory Committee on Immunization Practices for prevention of MPV. Ongoing safety monitoring occurs even after licensing. 

Adverse reactions after JYNNEOS include injection site reactions such as pain, swelling, and redness. Fatigue, headache, and muscle pain were the most common systemic reactions observed after JYNNEOS in a clinical trial.

Adverse events that occur in a recipient following MPV or smallpox vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS). Reporting is encouraged for any clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. Vaccine administration errors can be reported whether or not associated with an adverse event. Information on how to submit a report to VAERS is available online or by calling 1-800-822-7967.

Can JYNNEOS be given at the same time as other vaccines?

Smallpox/MVP vaccine, JYNNEOS, may be given at the same time as other vaccines. Certain people at increased risk of a condition called myocarditis (swelling of the heart muscle), including adolescents or young adult males, might consider waiting 4 weeks after JYNNEOS vaccination before getting an mRNA COVID-19 vaccine. 

More information can be found here: Considerations for Monkeypox Vaccination (CDC).

Who needs to get JYNNEOS intradermally versus subcutaneously?

JYNNEOS is recommended to be administered intradermally for people 18 years and older and subcutaneously for people under 18 years of age.

Intradermal administration should not be used for those under age 18 or some individuals at risk of keloid scar formation.  

Vaccine dosing schedule for JYNNEOS Monkey pox
The JYNNEOS package insert recommends subcutaneous administration. Why can I administer the vaccine intradermally?

An alternative regimen may be used for people age ≥18 years under an Emergency Use Authorization beginning August 9, 2022. The authorized alternative regimen involves an intradermal (ID) route of administration with an injection volume of 0.1mL. This approach could increase the number of available JYNNEOS vaccine doses by up to five-fold. Results from a clinical study showed that the lower intradermal dose was immunologically non-inferior to the standard subcutaneous dose (Frey SE et al, Vaccine, 2015; 33(39):5225-5234).

What are other site options if the forearm isn’t available for an intradermal administration of JYNNEOS?

If the volar aspect of the forearm is not an option (e.g., strong patient preference), intradermal administration of vaccine may be performed at the upper back below the scapula or at the deltoid.

If a person received a first dose of JYNNEOS 0.5 ml subcutaneously, can they get 0.1ml dose ID for the second dose?

When necessary, a person 18 years or older who received the first JYNNEOS vaccine dose subcutaneously may receive a second dose by the intradermal route to complete the vaccination series. A person whose 18th birthday occurs between their first and second dose may complete the series by the intradermal route.

Are there videos about administering JYNNEOS intradermally and subcutaneously?

Yes, see CDC guidance on JYNNEOS vaccine administration.

Where can I find the EUA for JYNNEOS vaccine?
What if I’m unable to produce a wheal with intradermal administration of JYNNEOS?

Producing a noticeable pale elevation of the skin (wheal) with the intradermal injection is desirable but not required.

What should I do if a patient has reactions on the forearm after the first dose of JYNNEOS?

A patient who presents for their second JYNNEOS vaccine dose who is still experiencing erythema or induration of the forearm should have the second dose administered intradermally in the other forearm. If that is not an option, administer intradermally in the upper back below the scapula, or intradermally at the deltoid.

What if a patient pulled away or JYNNEOS vaccine leaked out of the syringe?

Repeat the intradermal dose immediately (no minimum interval) at least 2 inches away from the site of vaccine leakage. If vaccine leakage occurs with two intradermal vaccinations on the same day, administer 0.5mL subcutaneously.

What if a wheal wasn’t produced with intradermal JYNNEOS administration and there was no vaccine leakage?

Absence of a wheal without vaccine leakage may be counted as valid administration.

Can I place a TB skin test (TST) at the same time as JYNNEOS vaccination?

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 JYNNEOS vaccination is preferred. If the JYNNEOS vaccine and the TST are administered on the same day, the vaccine and the TST should be administered on different forearms, one on the left and one on the right.

What supplies do I need to give an intradermal JYNNEOS vaccine?

Use a tuberculin syringe for ID administration. A 1/4 to 1/2 in., 26 or 27 gauge needle should be used.

Will ancillary kits be shipped with JYNNEOS vaccine?

No, there are no supplies that will be available.

What if a vaccine administration error occurred? Is there a resource to help address the error?

Yes, see CDC guidance on vaccine administration errors and deviations.

What are the precautions and contraindications to JYNNEOS vaccine?

Contraindication:
history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of JYNNEOS

Precautions: 

  • History of severe allergic reaction (e.g., anaphylaxis) following gentamicin or ciprofloxacin
  • History of severe allergic reaction (e.g., anaphylaxis) to chicken or egg protein AND are currently avoiding exposure to all chicken or egg product
  • Moderate or severe acute illness, with or without fever

For more information: JYNNEOS Vaccine (CDC)

What is the observation period post-vaccination?

Vaccine providers, especially when vaccinating adolescents, should consider observing patients (with patients seated or lying down) for 15 minutes after vaccination to decrease the risk for injury in case of fainting. 

Am I required to report adverse events to VAERS?

Providers who are administering JYNNEOS under the EUA are required to report the following adverse events that occur after JYNNEOS vaccination:

  • Vaccine administration errors whether or not associated with an adverse event
  • Serious adverse events (irrespective of attribution to vaccination)
  • Cases of cardiac events including myocarditis and pericarditis
  • Cases of thromboembolic events and neurovascular events
  • Information on how to submit a report to VAERS is available online or by calling 1-800-822-7967.
What storage & handling information do I need to know?

See JYNNEOS package insert.

The vaccine comes in packages of 20 single-dose vials. Store in the original package to protect from light.

Keep frozen at -25°C to -15°C (-13°F to +5°F) until expiration date. DO NOT store on dry ice or below -50°C (-58°F).

Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 8 weeks. Count 8 weeks from when the vial was first thawed and mark this “beyond use” date on the vial label. If the product expiration date on the carton is earlier, write that on the vial instead.

NEVER store vaccine in a “dormitory style” storage unit.

How long does it take to thaw the vaccine?

Allow the vaccine to thaw and reach room temperature immediately before use. A frozen vial will take less than 10 minutes to thaw at room temperature. Do not re-freeze a vial once it has been thawed.

Vaccine Handling Q and A (PDF)

What are the temperature monitoring requirements?

Always use a digital data logger (DDL) to monitor the temperature of vaccines during storage and transport.

Use Monthly Temperature Monitoring Log (PDF)

When positioning a DDL in a permanent vaccine storage unit, place the buffered probe in the center of the unit with the vaccines surrounding it, and attach the temperature display to the outside of the unit.

When packing a DDL in a vaccine transport container:

  • Make sure the buffered probe has been conditioned in the refrigerator or freezer prior to transport.
  • Remember to reset the minimum/maximum temperature display.
  • Place buffered probe as close as possible to vaccines in the transport container.
  • Do not place buffered probe directly next to ice packs or other coolants.
  • Attach temperature display to the outer lid of the transport container whenever possible.
  • Temperature excursions must be reported to the manufacturer to determine vaccine viability. DO NOT use vaccine that has experienced a temperature excursion until viability has been determined. Contact Bavarian Nordic at toll-free phone 1-800-675-9596.
  • More information is available here: MPV Vaccination Off-site Clinic Guidelines
Do I have to document the vaccination in the Immunization Information System (IIS)?

Yes, you are required to enter JYNNEOS administration in the WAIIS. Additionally, doses, lot, and expiration information should be manually entered as inventory in WAIIS upon receipt. This must be done manually since orders are not managed in these systems.

Monkeypox Vaccine Management WAIIS (PDF)

Instructions about adding, editing, and deleting vaccines

IIS Training Materials Portal | Washington State Department of Health

If I am using PrepMod, how do I document JYNNEOS?

The description in the vaccine dropdown does not specify .5 ml or .1 ml. You will need to specify the “route” (intradermal) administered and “volume” (.1) administered at the time of vaccination- based on the patient. It's important to ensure that site and route fields are completed accurately.

For more information: PrepMod: Washington State's Mass Vaccination System

What if I have vaccine that needs to be redistributed?

When redistributing vaccine to other providers, you must follow standard transportation guidance. Ensure continued temperature monitoring via digital data loggers.

Monitor and record temperatures during transport and maintain for your records.

The releasing provider must track date and time of redistribution, receiving provider info, lot number, expiration date, and number of doses redistributed.

Receiving and sending providers should modify their active inventory in the Washington State Immunization Information SYSTEM (WAIIS) (PDF) for improved tracking. MPV Vaccine Management in the WAIIS.

Should health care professionals get vaccinated?

At this time, the CDC does not recommend MPV vaccination for most health care professionals. Transmission in health care settings is rare. CDC recommends pre-exposure vaccination of persons at risk for occupational exposure to orthopoxviruses (such as laboratory workers who perform diagnostic testing to diagnose MPV). Most clinicians in the United States and laboratorians not performing the orthopoxvirus generic test to diagnose orthopoxviruses, including Monkeypox virus, are not advised to receive MPV vaccine PrEP.

See CDC recommendations for infection prevention and control of MPV in health care settings.

Is vaccination recommended for someone who was exposed and developed disease symptoms?

No, currently there is no known benefit for offering vaccination once someone has developed disease symptoms after exposure. If indicated, anti-viral treatment is a more effective clinical approach to support the individual. More information can be found at Monkeypox and Smallpox Vaccine Guidance (CDC).

What type of personal protective equipment should be worn during vaccinations?

Currently CDC recommends health care providers use standard precautions and follow current COVID-19 protocols, include respiratory protection, appropriate facemask, and eye protection. ​​​​​​Infection Control Healthcare Settings (CDC).

While the supply of JYNNEOS vaccine is limited, CDC recommends the following exceptions for a two-dose series:

  • A person who is diagnosed with MPV infection after their first dose of JYNNEOS is not recommended to receive the second dose at this time, because MPV infection likely confers additional immune protection.
  • A person who would be eligible for vaccination but has been diagnosed with MPV infection during this outbreak, which started in the United States on May 17, 2022, is not recommended to be vaccinated at this time because MPV infection likely provides immune protection.
  • An immunocompromised person who is diagnosed with MPV infection after their first dose of JYNNEOS may be eligible to receive the second dose of JYNNEOS on a case-by-case shared decision-making basis based on the clinical judgment of the health care provider.
  • More information: Considerations for Monkeypox Vaccination (CDC).
Can someone who has previously received JYNNEOS or another smallpox or orthopoxvirus vaccination be vaccinated during this current outbreak?

Previous smallpox vaccination does provide protection, but it may not necessarily be lifelong. During the 2003 MPV outbreak and during the current monkeypox outbreak, several people who were infected with MPV had previously been vaccinated.

In the current MPV outbreak response, persons exposed to monkeypox virus and who have not received the smallpox vaccine within the last 3 years should consider getting vaccinated.

Can a Medical Assistant give the JYNNEOS vaccine under Emergency Use Authorization?

The medical assistant-certified (MA-C) and medical assistant-registered (MA-R) can administer vaccines if properly trained and delegated. The MA laws are not specific as to what kind of vaccines are within scope, so the type of vaccine is not limited by rule or statute. The JYNNEOS vaccine is issued under an Emergency Use Authorization (EUA) for intradermal route for adults and subcutaneously for adolescents/children by the Food and Drug Administration (FDA). See the Providers Authorized to Administer and Order Vaccines (PDF) chart for other health care professions that are authorized to administer vaccines.

Can a Medical Assistant (MA) give vaccine from a multidose vaccine vial?

An MA can administer a vaccine that the supervising HCP has drawn up from a multidose vial. Per RCW 18.360.050(f)(i)(A), medications must be “administered only by unit or single dosage, or by a dosage calculated and verified by a health care practitioner. For purposes of this section, a combination or multidose vaccine shall be considered a unit dose.”

Can a Medical Assistant administer JYNNEOS vaccine intradermally?

Both the medical assistant-certified (MA-C) and medical assistant-registered (MA-R) may administer intradermal JYNNEOS vaccine. The MA-C rules are more specific for medication administration and injections. See WAC 246-827-0240.

Tecovirimat (TPOXX) Provider FAQs

What treatments for MPV are available?

Currently there is no treatment approved specifically for MPV disease. However, antivirals developed for use in patients with smallpox may be beneficial against MPV. Tecovirimat (TPOXX), an antiviral medication, is available through the CDC at no cost to treat MPV disease under the Expanded Access Investigational New Drug protocol (EA-IND). Both oral and intravenous formulations are available. Other treatments may also be used in particular situations; see CDC guidance for more information.

Treatment Information for Healthcare Professionals (CDC)

Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Cases (CDC)

 When is antiviral treatment indicated?

Many individuals infected with MPV have a mild, self-limiting disease course without specific therapy. However, antiviral treatment is available for patients at high risk of severe disease Treatment Information for Healthcare Professionals (CDC), and those with infections involving accidental implantation in eyes, mouth, or other anatomic areas where MPV virus infection might constitute a special hazard (e.g., the genitals or anus). 

How much tecovirimat has been allocated to Washington state?

Tecovirimat allocation differs from JYNNEOS vaccine allocation; jurisdictions have not been given designated allocation amounts. Currently, we can order tecovirimat as needed to treat patients in Washington state.

Do I need to be an infectious disease specialist to prescribe tecovirimat? 

No. Any provider can prescribe tecovirimat if they can adhere to the EA-IND protocol. 

Whom do I contact to become a tecovirimat prescriber?

Reach out to your local health jurisdiction to indicate you would like to become a tecovirimat provider. It’s important that your local health jurisdiction know that you are providing tecovirimat so they can direct patients to appropriate providers.

How do I obtain tecovirimat for my patients? 

Tecovirimat is available to local health jurisdictions (LHJs) through the state Department of Health. All health care facilities and providers interested in participating in the IND process should direct tecovirimat medication requests to your local health jurisdiction. 

Can a health care facility or provider maintain an onsite tecovirimat pharmacy or act as a referral site for MPV services?

Providers and facilities interested in participating in the tecovirimat prescribing services should contact their local health jurisdiction for more information.

Where can I find information about the EA-IND process?

Because tecovirimat is FDA-approved only for treatment of smallpox, CDC holds a protocol to allow access to and use of tecovirimat for treatment of non-variola orthopoxvirus infections, including MPV infection. For more information on the EA-IND protocol and associated forms, see CDC guidance: Obtaining and Using TPOXX (Tecovirimat).

Can providers use telemedicine during the IND process?

Yes. All patient visits/encounters can be conducted via telehealth.

What forms do I need to fill out as a tecovirimat IND process investigator?

As an investigator, it is your responsibility to obtain documentation for each patient receiving tecovirimat. The following forms are required as part of the EA-IND documentation: 

  • Informed Consent Form (PDF) – Obtain prior to treatment. Other languages are available on the CDC website for Obtaining and Using TPOXX (Tecovirimat). An Alternative Short Consent Form (PDF) and Written Summary (PDF) are available and can be used to obtain informed consent.
  • Patient Intake Form (PDF) – Baseline assessment.
  • FDA Form 1572 (PDF) – This is a facility and provider enrollment form; it is not required for each patient. Only one form is required for each facility or provider. The form, once submitted, will cover all prescriptions for that provider or providers within a facility. The form can be submitted in advance or after TPOXX prescription and revised at any given time and resubmitted to CDC, but must be submitted within seven (7) calendar days of tecovirimat initiation.
  • Serious Adverse Events: Report life-threatening or serious adverse events associated with tecovirimat by completing a PDF MedWatch Form (PDF) and returning it to CDC via email (regaffairs@cdc.gov) or uploading to ShareFile within 72 hours of awareness or sooner, if possible. The PDF MedWatch Form can also be downloaded from the FDA website. (Note: The MedWatch Form can only be viewed on the Adobe desktop app. Please save or download the form for viewing.)
  • Optional forms (patient diary and clinical outcomes), recommendations for baseline and post-treatment photos, and guidance for testing lesions and plasma through the treatment monitoring process are on the CDC website for Obtaining and Using Tecovirimat.
Is the informed consent form available in other languages?

As of October 14, 2022, the informed consent form is available in Spanish, Arabic, Korean, Russian, Simplified Chinese, Tagalog, and Vietnamese.

I work as part of a large health care system. Do I need to obtain a 1572 for each facility and clinic in my system?

No, you do not. The 1572 is intended to identify a principal investigator that will be accountable for documentation associated with patients receiving tecovirimat. If it works for your health care system to have the principal investigator at the health system level, that’s okay! 

Please note – if your health care system spans multiple local health jurisdictions it is important to notify all local health jurisdictions where tecovirimat prescribers will be located. 

I have a patient that does not neatly fit into the CDC guidance for tecovirimat administration but feel they do need treatment. Can I still prescribe tecovirimat?

Yes, the guidance from CDC is not meant to restrict access to patients that need treatment. Ultimately it is up to the clinician’s discretion to prescribe. If a clinical consult is necessary, please contact your local health jurisdiction. 

Do all hospitalized patients require IV tecovirimat?

No, any patient that can tolerate oral tecovirimat should take the oral formulation. Patients who cannot swallow can receive IV tecovirimat but should be switched to oral preparation as soon as it can be tolerated. This means that one course of IV tecovirimat may be split among different patients depending on when the oral formulation is introduced. 

I have a patient with high clinical suspicion for MPV disease, but test results are pending. Can I prescribe tecovirimat empirically? 

Yes, tecovirimat treatment may be initiated for patients with suspected MPV disease based on known exposure(s) and/or clinical manifestations of disease.

Who should not receive tecovirimat?

Patients who are unwilling to sign informed consent documentation or those with a known allergy to the drug or its components should not receive tecovirimat. Tecovirimat IV preparation is also contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min).

Can tecovirimat be used in pediatric populations?

Yes. Dosing considerations can be found in the EA-IND protocol.

What should I do if I have additional questions about treatment? 

For additional questions, contact your local health jurisdiction (LHJ) or DOH by email. If you're unable to reach your local health jurisdiction and need urgent clinical advice, call 206-418-5500 to be connected with the DOH clinical epidemiologist on call.

End of Public Health Emergency

How does the mpox Public Health Emergency (PHE) expiring impact the process by which JYNNEOS is ordered? Will HPOP continue to be the system the vaccine is ordered through?

The ending of the mpox PHE has no impact on the ordering process. See the ASPR/CDC Mpox Vaccination Operational Planning Guide for the ordering and reporting process.

How did the end of the mpox Public Health Emergency (PHE) change mpox vaccine reporting, including of doses administered?

The expiration of the mpox PHE had no impact on current requirements for vaccine reporting, as outlined in the DUA and as described in the ASPR/CDC Mpox Vaccination Operational Planning Guide, and required under the HHS Mpox Vaccination Program Provider Agreement.  The provider agreement must continue to be shared regularly with every provider that receives mpox vaccine. In some jurisdictions, local regulations may affect the type of data that can be reported to CDC after the expiration of the mpox PHE. Please notify CDC if this applies to your jurisdiction. 

Is the mpox Data Use Agreement (DUA) contingent upon the mpox Public Health Emergency (PHE) or is it contingent on the PREP Act?

The mpox DUA is not contingent upon the mpox PHE, and the DUAs will continue to remain in effect. The DUA is not related to the PREP Act.

With the ending of the mpox Public Health Emergency (PHE), will the PREP Act no longer cover pharmacists to administer JYNNEOS?

The PREP Act Coverage for Countermeasures against Smallpox, Mpox, and other Orthopoxviruses includes liability coverage for countermeasures that are licensed, approved, or authorized for emergency use or investigational use by the FDA. This includes therapeutics, devices, tests, and vaccines against smallpox, mpox virus, and other orthopoxviruses. The PREP Act covers licensed healthcare professionals, including pharmacists, who administer countermeasures that relate to any federal agreement or arrangement (e.g., provider agreements, distribution from the Strategic National Stockpile).  This coverage is independent of the PHE or any emergency declaration, so pharmacists continue to be covered under the PREP Act (along with other licensed healthcare professionals) to administer vaccine even if no emergency declaration is in effect.

In addition, the PREP Act declaration for smallpox, mpox and other orthopoxviruses covers providers who are authorized by a state or local jurisdiction to respond to a declared emergency (such as a provider authorized under a state emergency authority to respond to a state declared emergency).  The PREP Act declaration also authorizes providers who are not otherwise licensed or authorized under state law to administer smallpox, mpox, and orthopoxvirus countermeasures during a declared emergency.  The declared emergency may be a federal, regional, state, or local emergency specific to the need to administer countermeasures and does not have to be a PHE.

Thus, pharmacists and other healthcare providers authorized by a state or authorized by the declaration continue to be covered under the PREP Act as long as an emergency declaration indicating the need to administer countermeasures in a particular area is in effect as long as other conditions stated in the declaration, such as appropriate training, have been met.  

Can JYNNEOS continue to be administered intradermally once the mpox Public Health Emergency (PHE) expires? Do the EUAs permitting intradermal administration and use of JYNNEOS vaccine for individuals under 18 years remain in place?

The end of the Public Health Emergency (PHE) Declaration under Section 319 of the Public Health Service (PHS) Act does not impact EUA declarations under Section 564 of the Food, Drug, and Cosmetic Act that allow FDA to issue EUAs. An EUA can remain in effect after the end of a PHE Declaration under Section 319 of the PHS Act.

Therefore, although the PHE declaration for mpox expired on January 31, 2023, JYNNEOS can continue to be administered intradermally and be given to persons under 18 years in accordance with the EUA. 

How does the end of the mpox Public Health Emergency (PHE) impact the HHS Mpox Vaccination Program Provider Agreement?

The ending of the mpox PHE has no impact on the HHS Mpox Vaccination Program Provider Agreement which remains in effect as long as the jurisdiction continues to administer JYNNEOS vaccines received from the U.S. government. See also the ASPR/CDC Mpox Vaccination Operational Planning Guide.

Will there be any changes to the expectation that we share the Mpox Vaccination Program Provider Agreement with providers once the mpox Public Health Emergency (PHE) ends?

The HHS Mpox Vaccination Program Provider Agreement must continue to be shared regularly with every provider who receives mpox vaccine. As long as the U.S. government continues to be the source of the vaccines, the HHS Mpox Vaccination Program Provider Agreement must continue to be shared with mpox vaccine providers even after the mpox PHE ends. See also the ASPR/CDC Mpox Vaccination Operational Planning Guide.

How will CDC/ASPR determine the allocation of vaccine to states in the future as the cases of mpox continue to decline or stabilize?

See the ASPR/CDC Mpox Vaccination Operational Planning Guide and email on thresholds that was emailed to each jurisdiction on December 15, 2022. ASPR will continue monitoring any changes to mpox cases and update the guidance accordingly.

Will TPOXX continue to be pre-positioned?

As part of the U.S. government’s response to the mpox outbreak, the Strategic National Stockpile has deployed more than 40,000 treatment courses of Tecovirimat (TPOXX) to U.S. jurisdictions; many of these treatment courses were deployed as part of oral TPOXX pre-positioning efforts during periods of high domestic transmission of the mpox virus. Much of this product remains in inventory across the nation. Based on the current outbreak trajectory, ASPR is pausing the pre-positioning of oral TPOXX, effective Monday February 27, 2023.

Remaining supplies of previously pre-positioned TPOXX can continue to be used to treat mpox patients according to the expanded access Investigational New Drug (EA-IND) protocol and in concert with CDC’s Guidance for Tecovirimat Use.

To ensure compliance with FDA requirements and IND regulations, the treating providers are reminded to complete and return the required IND forms to CDC as outlined on Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Mpox website.

Oral TPOXX remains available to treat eligible patients with mpox under the ongoing NIH-supported STOMP trial. Providers are encouraged to inform patients of the availability of TPOXX treatment through STOMP. Interested participants can contact one of the clinical research sites or contact the call center at 1-855-876-9997.

For those who cannot enroll in STOMP due to eligibility criteria and/or accessibility to trial sites (remote consent is available), TPOXX remains available under the CDC-held expanded access Investigational New Drug (EA-IND) protocol. Clinicians with mpox patients requiring oral or intravenous (IV) TPOXX treatment or in urgent clinical situations may reach out for clinical consultation with CDC; requests for consultation can be made by contacting the CDC Emergency Operations Center 770-488-7100.

ASPR will continue monitoring any changes to mpox cases and update the TPOXX Operational Guidance accordingly.

What should jurisdictions do with the remaining supplies of TPOXX?

Remaining supplies of previously pre-positioned TPOXX can continue to be used to treat eligible patients according to the expanded access Investigational New Drug (EA-IND) protocol. To ensure compliance with FDA requirements and IND regulations, the treating providers are reminded to complete and return the required IND forms to CDC as outlined on Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of mpox website.

For clinicians with mpox patients requiring oral or intravenous (IV) TPOXX treatment or in urgent clinical situations for clinical consultation with CDC, requests for consultations can be made by contacting the CDC Emergency Operations Center 770-488-7100.

What should jurisdictions and providers do with excess doses of mpox vaccines and therapeutics?

Once medical countermeasures for mpox are deployed, they cannot be returned to the Strategic National Stockpile. This applies to all product deployed as part of the mpox response, including JYNNEOS, ACAM2000, and TPOXX.

Product Transfer: Jurisdictions may share/transfer excess product that has been stored according to its specifications. Product can be transferred within a jurisdiction or to other jurisdictions, if needed, in accordance to state and local regulations. We request that jurisdictions maintain inventory records regarding any products that are shared in the respective transferring and receiving entities’ documentation.

Product Expiration: Jurisdictions can identify expiration date by lot number for JYNNEOS vaccines and both oral TPOXX and IV TPOXX products at Vaccines and Treatment for Mpox | SNS | HHS/ASPR. We strongly encourage jurisdictions to continue storing excess product that is not expired.

  • At this time, there are no anticipated dating extensions for oral TPOXX, and some lots of oral TPOXX will begin expiring as early as March 2023. Once oral TPOXX is expired, jurisdictions may dispose of the product using their own established protocols for disposal. Information on safe disposal of medicines is available on the FDA website.
  • We request that jurisdictions maintain records of lot numbers and quantities of products that are destroyed. While there are currently no anticipated dating extensions for oral TPOXX, jurisdictions are free to hold expired product in quarantine if they choose to do so. 
  • IV TPOXX may be eligible for expiration extension, and jurisdictions are strongly encouraged to continue storing IV TPOXX even beyond current expiration dates. As more information becomes available, the expiration dates will be updated on the website. These products are important for maintaining preparedness for future mpox, smallpox, and other orthopoxvirus outbreaks or responses.

Resources

Guidelines and Considerations

Standing Orders

Storage and Handling

Testing

Vaccine Administration

Vaccine Information Statement

Reporting

Youth

Additional Resources

For general questions about MPV risk factors, vaccines, testing, or treatment in Washington state: Call 1-833-829-HELP. Language assistance is available in 240 languages.

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