Monkeypox (MPV) Provider FAQs and Resources

New information about pediatric and intradermal vaccinations (8/11/2022)

General

Where can I find information about the outbreak?

For updates on the outbreak in Washington state: Monkeypox | Washington State Department of Health

For updates on the outbreak in the U.S.: U.S. Monkeypox Outbreak 2022: Situation Summary | Monkeypox | Poxvirus | CDC

How can I reduce stigma when talking about monkeypox?

Anyone can get MPV, which is a public health issue important to everyone. For guidance on how you can reduce stigma in MPV communication and engagement: Reducing Stigma in Monkeypox Communication and Community Engagement | Monkeypox | Poxvirus | CDC.

Clinical Information

How is MPV diagnosed?

Use the Clinical Recognition | Monkeypox | Poxvirus | CDC  for information on diagnosing MPV including photos of MPV rashes.

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

Yes, MPV is diagnosed through a PCR test done on a swab of the rash and is available at several clinical and academic laboratories as well as the Washington State Public Health Laboratories (WSPHL). Testing by WSPHL requires approval from the patient’s local health jurisdiction. See DOH guidance on MPV testing including specimen collection and transport instructions.

Is MPV a notifiable condition?

Yes, MPV is a notifiable condition. You will need to report any cases you diagnose. Find information and forms on DOH’s Notifiable Conditions webpage under “monkeypox.”

Where do I find more clinical guidance on MPV?

Visit these CDC’s pages:

Where is more information available about MPV and pets?

Visit: Washington State Guidelines on Monkeypox in Animals.

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 9th 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, please 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 on their website 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 | Monkeypox | Poxvirus | 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, www.cdc.gov/poxvirus/monkeypox/interim-considerations/jynneos-vaccine.html#admin 

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, follow: www.cdc.gov/poxvirus/monkeypox/interim-considerations/errors-deviations.html

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 | Monkeypox | Poxvirus | 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 at https://vaers.hhs.gov or by calling 1-800-822-7967.
What storage & handling information do I need to know?

Package insert (https://www.fda.gov/media/131078/download).

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)

348-715-AddEditDeleteVaccines.pdf (wa.gov)

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 | Washington State Department of Health

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.

Please see CDC recommendations for infection prevention and control of MPV in health care settings:  Infection Control: Healthcare Settings | Monkeypox | Poxvirus | CDC.

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 | Monkeypox | Poxvirus | 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 | Monkeypox | Poxvirus | 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 | Monkeypox | Poxvirus | 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. However, antivirals developed for use in patients with smallpox may prove beneficial against MPV. Tecovirimat (TPOXX), an antiviral medication, is available through the CDC at no cost to treat MPV infection under the Expanded Access Investigational New Drug protocol (EA-IND). Both oral and intravenous formulations are available. 

Treatment Information for Healthcare Professionals | Monkeypox | Poxvirus | CDC 

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

 When is 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 | Monkeypox | Poxvirus | 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 TPOXX has been allocated to Washington state?

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

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

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

Whom do I contact to become a TPOXX prescriber?

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

How do I obtain TPOXX for my patients? 

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

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

We are working with our medical countermeasures team and the CDC to obtain guidance on prepositioning TPOXX in LHJs. Providers and facilities interested in participating in the TPOXX prescribing services should contact their local health jurisdiction for more information.

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

For more information on the EA-IND protocol and associated forms, visit the CDC monkeypox website and search for 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 TPOXX IND process investigator?

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

Is the informed consent form available in other languages?

CDC is working on translations of the informed consent document and once available those versions will be posted on its website

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 TPOXX. 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 TPOXX prescribers will be located. 

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

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 TPOXX?

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

I have a patient that has high risk of MPV, but test results are not in yet. Can I prescribe TPOXX empirically? 

Yes, Tecovirimat treatment may be initiated for patients with laboratory confirmed non-variola orthopoxvirus infection or suspected infection based on known exposure(s) and/or clinical manifestations of disease.

Who should not receive TPOXX?

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

Can TPOXX 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 by email.

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.

Washington 211 call takers are available from 6:00 a.m. to 10:00 p.m. Monday, and 6:00 a.m.to 6 p.m. Tuesday through Sunday and observed state holidays. Call takers will not be able to schedule vaccine appointments.

For people who are deaf, hard of hearing, and TTY users: Use your preferred relay service or dial 711, then 1-833-829-4357 (HELP).