CDC has launched the Mpox Vaccine Equity Pilot Program to demonstrate new, innovative, and non-traditional ways to address vaccination disparities among people who are most affected. VDH is currently accepting applications for this program. For details, visit the VDH Equity in mpox website.
Role of a Healthcare Provider in the Mpox Vaccination Response
Healthcare providers should be aware of the groups of people recommended for mpox vaccination and the currently available vaccines. Providers may refer those eligible for vaccination to their Local Health District for more information on how to receive a vaccination or they may enroll to become an mpox vaccination provider. Steps to take to enroll as an mpox vaccination provider are listed below. Mpox vaccine is not routinely recommended for the general public, and is intended to be used in very specific groups that have a higher risk for exposure.
For more information, please visit CDC What Healthcare Professionals Should Know.
Steps to Enroll as Mpox Provider
If you wish to enroll as an mpox vaccination provider, please review this one page JYNNEOS Information Sheet and follow these steps :
- Review the HHS Provider Agreement to understand requirements of mpox vaccine providers and prepare to attest to these requirements.
- Email the VaxMaX Help Desk at email@example.com to declare intent to order and administer the mpox vaccines in accordance with the HHS Provider Agreement requirements. VaXMaX will provide next steps for attestation.
- Review the following VDH resources that may be adapted to fit your practice site:
Please note the JYNNEOS vaccine is intended to be administered intradermally (ID). Staff must be adequately trained on proper ID administration technique. It is recommended that hands-on training be conducted to ensure adequate technique.
End of Public Health Emergency Declaration
On December 2, 2022, HHS announced that the Public Health Emergency (PHE) declaration for mpox will not be renewed and it expired on January 31, 2023. As a result, VDH will no longer be able to maintain the Mpox Statewide Standing Order authorizing the dispensing and administration of the mpox vaccine. This standing order was revoked on January 31, 2023, following expiration of the mpox PHE. The following CDC standing orders may be used after January 31, 2023
- CDC Standing Order for Subcutaneous Administration
- CDC Standing Order for Intradermal Administration
Following the standing order decommission, pharmacists may continue to order, dispense and administer the JYNNEOS vaccine under their individual National Provider Identifier in accordance with the Public Readiness and Emergency Preparedness (PREP) Act. Pharmacy technicians, pharmacy interns, registered nurses and licensed practical nurses may administer the JYNNEOS vaccine pursuant to an order from a prescriber.
PHE expiration does not affect the EUA for JYNNEOS. JYNNEOS can continue to be administered to people under the age of 18 through the subcutaneous route and to adults through the intradermal route (see Currently Available Vaccines section).
Providers may continue to order JYNNEOS as needed through VaxMax and monthly reporting requirements will continue to be required for all JYNNEOS vaccine providers.
For Healthcare Providers Administering Mpox Vaccines:
- All vaccine providers in Virginia must report any doses administered to the Virginia Immunization Information System (VIIS).
- V-safe can now be used for safety tracking of mpox vaccine. All providers should encourage patients to register with V-safe.
- CDC’s V-safe after vaccination health checker is a smartphone-based system that uses text messaging and web surveys to provide personalized and confidential health check-ins. Participants can tell CDC how they, or their child or dependent, feel after they receive any dose of a COVID-19 vaccine (including an updated bivalent booster) or an mpox vaccine. Participation in V-safe helps CDC monitor the safety of vaccines.
- Vaccine adverse events for mpox vaccines are monitored through Vaccine Adverse Events Reporting System (VAERS) along with CDC vaccine surveillance systems: the Vaccine Safety Datalink (VSD) and the Clinical Immunization Safety Assessment (CISA) team. For more information, visit Vaccine Safety Monitoring | Vaccine Safety | CDC.
- Providers should report any clinically significant adverse event following vaccination to the VAERS.
- For more information visit CDC VAERS.
Two vaccines may be used for the prevention of mpox virus infection:
- JYNNEOS (also known as Imvamune or Imvanex), licensed (or approved) by the U.S. Food and Drug Administration (FDA) for the prevention of mpox virus infection in adults 18 years and older. On August 9, 2022, the FDA issued an Emergency Use Authorization (EUA) for JYNNEOS for individuals under the age of 18 years old.
- ACAM2000, licensed (or approved) by FDA for use against Smallpox virus and made available for use against mpox virus under an Expanded Access Investigational New Drug (IND) application.
- Research on vaccine effectiveness is ongoing, but evidence indicates that JYNNEOS vaccination provides protection against mpox. Initial licensure was supported by animal and clinical studies showing development of antibodies after vaccination.
- A recent CDC MMWR reported among males in the U.S. aged 18–49 years eligible for vaccination, mpox incidence among unvaccinated persons was 9.6 times as high as that among persons who had received 2 vaccine doses and 7.4 times as high as that among persons who had received only the first dose ≥14 days earlier.
- This analysis also suggested no difference in vaccine performance between subcutaneous and intradermal administration.
- Another recent CDC MMWR supports JYNNEOS vaccine safety during the current outbreak.
- During May 22–October 21, 2022, nearly 1 million JYNNEOS doses were administered in the U.S. The vaccine safety profile was consistent with prelicensure studies. The most common adverse health events reported were non-serious and included injection site reactions. Serious adverse events were rare among adults, and no serious adverse events have been identified among persons aged <18 years.
JYNNEOS is an attenuated live virus vaccine which has been approved or authorized for the prevention of mpox.
- Because JYNNEOS is licensed as a two-dose series, CDC continues to recommend two doses of JYNNEOS vaccine to prevent mpox disease, regardless of how or where it is administered. The two doses should be given 28 days apart.
- 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.
- The level of protection provided by only one dose is not known.
- During this outbreak, the alternative regimen (intradermal route) is preferred, but the JYNNEOS vaccine may be administered subcutaneously using the standard regimen (subcutaneous route).
- People of any age with a history of developing keloid scars and individuals younger than 18 years of age should receive the vaccine via the subcutaneous route.
- Patients with concerns about intradermal administration due to potential stigma or other personal reasons should be offered subcutaneous doses.
- CDC recommends that healthcare providers have both subcutaneous and intradermal vaccine administration options available on site so that those unable or unwilling to receive the intradermal regimen, can receive the subcutaneous regimen.
- As a reminder, vaccines should not be administered after the onset of illness. If a patient develops symptoms consistent with mpox illness at the time of vaccination, the patient is no longer eligible to receive the vaccine, regardless of previous eligibility status. Vaccination given after the onset of signs or symptoms of mpox is not expected to provide benefit.
- If a patient has been diagnosed with mpox previously, they are not eligible for vaccination.
- If a patient develops mpox before receiving their second dose, they are no longer eligible to receive the second dose.
- For more information about JYNNEOS, please refer to the Package Insert, as well as CDC JYNNEOS Interim Clinical Considerations.
- For more information and guidance on the EUA for JYNNEOS use for individuals under the age of 18 years old, please refer to the EUA HCP Fact Sheet and the CDC Interim Clinical Considerations .
- Smallpox/Monkeypox Vaccine (JYNNEOS) Vaccine Information Statement.
ACAM2000 contains a live replicating vaccinia virus, licensed by the FDA for immunization in people who are at high risk for smallpox infection. ACAM2000 may be used as an alternative to JYNNEOS vaccine.
Interchangeability of Dosing Regimens
Dosing regimens are interchangeable. For example, a person aged 18 years or older who received one JYNNEOS vaccine dose with the standard subcutaneous regimen may receive a second dose with the alternative intradermal regimen at the recommended interval (i.e., 28 days) to complete the vaccination series. Another example is a person who received the first dose intradermally, had a robust local reaction, and refuses a second dose unless given subcutaneously. In this situation, that second dose can be given subcutaneously.
Coadministration with Other Vaccines
Generally, JYNNEOS may be administered without regard to timing of other vaccines.
Orthopoxvirus vaccination should not be delayed due to recent receipt of a COVID-19 vaccine; no minimum interval between COVID-19 vaccination and orthopoxvirus vaccination is necessary.
People, particularly adolescent or young adult males, might consider waiting 4 weeks after orthopoxvirus vaccination (either JYNNEOS or ACAM2000) before receiving a COVID-19 vaccine, because of the observed risk for myocarditis and/or pericarditis after receipt of ACAM2000 orthopoxvirus vaccine and mRNA (i.e., Moderna and Pfizer-BioNTech) and Novavax COVID-19 vaccines and the unknown risk for myocarditis and/or pericarditis after JYNNEOS administration. For more information, please view CDC Interim Considerations.
Vaccination Strategies to Prevent Mpox
- Those who, within the past 14 days, have had an intermediate to high risk exposure to a known and documented mpox case
- Those with certain risk factors and recent experiences that might make them more likely to have been recently exposed to mpox:
- Person (of any sexual orientation or gender) who has had anonymous or multiple (more than 1) sexual partners in the last 2 weeks
- Person (of any sexual orientation or gender) diagnosed with any sexually transmitted infection in the past three months
- Person (of any sexual orientation or gender) who is living with HIV/AIDS
- Staff (of any sexual orientation or gender) at establishments or events where sexual activity occurs
- Sex workers (of any sexual orientation or gender)
- Those whose jobs may expose them to orthopoxviruses, such as mpox; examples include:
- Healthcare providers who are administering ACAM2000
- Laboratorians handling mpox specimens
²At this time, most clinicians and laboratorians in the United States are not advised to receive the mpox vaccine for pre-exposure prophylaxis. For additional information regarding PrEP, visit CDC Mpox and Smallpox Vaccine Guidance and ASPR/HHS Vaccination Strategies.
Following exposure of a confirmed mpox case, the CDC recommends that the vaccine be given as soon as possible after exposure, preferably within 4 days.
- During days 0-4 after exposure for intermediate- and high-risk contacts to prevent onset of disease. The sooner an exposed person gets the vaccine, the better.
- During days 4-14 after the exposure for high-risk contacts. Vaccination may reduce the symptoms of disease, but may not prevent the disease.
- During days 4-14 after the exposure for intermediate-risk contacts, informed decision making is recommended on an individual basis to determine whether benefits of prophylaxis outweigh the risks.
The VDH no longer requires proof of Virginia residency to receive mpox vaccination.
- AMA Smallpox & Mpox Immunization CPT Codes
- Interim Recommendations for JYNNEOS Vaccine Administration Errors and Deviations (CDC)
- Intradermal JYNNEOS Mpox Vaccine Fast Facts (FDA)
- JYNNEOS Standing Order Template (for 18 years and older) (CDC)
- JYNNEOS Storage and Handling Summary (CDC)
- Package Insert – JYNNEOS
- Smallpox/Mpox Vaccine (JYNNEOS) Vaccine Information Statement (CDC)
- Video on How to Administer Intradermal Vaccine in Forearm, Deltoid, and Scapula (CDC)
- Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Mpox Outbreak (CDC)
- Seven Questions on Mpox Vaccines with Dr. Daskalakis
- Use of JYNNEOS (Smallpox and Mpox Vaccine, Live, Nonreplicating) for Preexposure Vaccination of Persons at Risk for Occupational Exposure to Orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022
Page updated: January 31, 2023
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