Vaccine Guidance

JYNNEOS vaccine is used to prevent smallpox and mpox in people at high risk for infection. During the current mpox outbreak, JYNNEOS is the only vaccine being administered in the U.S. JYNNEOS (also known as Imvamune or Imvanex) is licensed (or approved) by the U.S. Food and Drug Administration (FDA) to prevent mpox in people aged 18 years and older. It is also available under an Emergency Use Authorization (EUA) for the subcutaneous administration in people under the age of 18 years old and the intradermal administration for people aged 18 years and older.

ACAM2000 vaccine may also be used to prevent mpox, but it has not been used in the current mpox response.

Provider Resources 

JYNNEOS Vaccine Information Statement

JYNNEOS Package Insert

CDC Mpox Vaccine Considerations

Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Mpox Outbreak

FDA JYNNEOS EUA Fact Sheet for Providers (8/2022)

FDA JYNNEOS EUA Fact Sheet for Patients and Caregivers (8/2022)

VDH has adopted CDC’s mpox vaccine recommendations. On October 25, 2023, CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended routine vaccination with the 2-dose JYNNEOS vaccine series for persons aged 18 years and older at risk for mpox. This interim recommendation will be revisited in 2–3 years. CDC has updated its immunization schedules based on the new recommendation. The prior ACIP recommendations had been for use of JYNNEOS only during an outbreak.

Note: Persons living with HIV or other immunocompromising conditions may be at higher risk for severe outcomes of mpox and should be a high priority for vaccination.

Individuals may attest to meeting one or more of the eligibility criteria for vaccination, however, should not be required to attest to a specific criterion nor should they be asked details about their eligibility.

Currently, most clinicians and laboratorians in the United States are not advised to receive the mpox vaccine for prophylaxis (vaccination before exposure) unless sexual risk factors are present.

CDC has developed an to help people find a vaccination site near them.

Following exposure to a confirmed mpox case, CDC that the vaccine be given as soon as possible after exposure, preferably within four days.

• Vaccinating during days 0-4 after exposure can prevent onset of the disease. The sooner an exposed person gets the vaccine, the better.
• During days 4-14 after exposure, the vaccine has been shown to be effective and should be offered. After 14 days, clinicians should consider the benefits of receiving the vaccine on a case-by-case basis. Benefits may still outweigh risks when administering vaccine in some clinical situations (e.g., for a severely immunosuppressed person with a recent sex partner confirmed to have mpox).

Exclusions

• Vaccines should not be administered after symptoms begin. If a patient presents with 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.

Provider Resources

VDH What Vaccines Do You Need? infographic – is for patients at risk of mpox and has information about mpox vaccine, as well as flu, COVID-19, and meningococcal vaccines.

CDC Mpox Vaccine webpage

Mpox cases in the United States are becoming increasingly rare, but unvaccinated and under-vaccinated people who could benefit from vaccine may still be at risk. The best protection against mpox occurs two weeks after the second dose, so patients should plan before attending events where they may be at risk and use other strategies to prevent mpox.

• It’s never too late to get a second dose of JYNNEOS vaccine even if someone received their first dose several months or even a year prior.
• People who were already vaccinated with two doses or were previously infected with mpox do not need an additional dose of JYNNEOS vaccine unless they have ongoing risk because of their job.

Dosing

• Because JYNNEOS is licensed as a two-dose series, CDC continues to recommend two doses of JYNNEOS vaccine to prevent mpox, 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 the series or add additional doses to the series if there is an extended interval between doses.
• Peak immunity is expected 14 days after the second dose. The duration of immunity after one or two doses of JYNNEOS is currently unknown.
• Two doses of JYNNEOS provide the best protection against mpox.

Route of administration

• The JYNNEOS vaccine may be administered using the standard FDA-approved regimen (subcutaneous route) OR the alternative EUA-authorized regimen (intradermal 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.
• For people aged 18 years or older, providers may discuss with patients to determine which route of administration each patient prefers.
  • Patients with concerns about intradermal administration due to potential stigma or other personal reasons should be offered subcutaneous doses.
  • CDC 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.

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.
• Mpox vaccination should not be delayed due to recent receipt of a COVID-19 vaccine; no minimum interval between COVID-19 vaccination and mpox vaccination is necessary.
• People (particularly adolescent and young adult males) who are recommended to receive both mpox and COVID-19 vaccines might consider waiting 4 weeks between vaccines. This is due to the observed risk for myocarditis and pericarditis after receipt of ACAM2000 orthopoxvirus vaccine and COVID-19 vaccines; and therefore, the hypothetical risk for myocarditis and pericarditis after JYNNEOS vaccine. However, if a patient’s risk for mpox or severe disease due to COVID-19 is increased, administration of mpox and COVID-19 vaccines should not be delayed.

Provider Resources 

CDC JYNNEOS Interim Guidance

CDC Video: How to Administer Intradermal Vaccine in Forearm, Deltoid, and Scapula

CDC Interim Recommendations for JYNNEOS Vaccine Administration Errors and Deviations

FDA Intradermal JYNNEOS Monkeypox Vaccine Fast Facts

AMA Smallpox & Monkeypox Immunization CPT Codes

HHS Mpox and HIV Resources

CDC and KFF’s We Are Greater Than Mpox Video Series

Recent studies indicate that JYNNEOS vaccination provides real-world protection against mpox. In these reports, vaccine effectiveness was 66–89% with two doses of JYNNEOS vaccine and 36–75% with one dose of JYNNEOS vaccine. Two doses of vaccine provide the best protection. While people who have been vaccinated can still get mpox, vaccination may make illness less severe.

No differences in vaccine effectiveness have been observed between intradermal or subcutaneous routes of administration. While recent data suggest that vaccine effectiveness was higher in immunocompetent people compared with self-reported immunocompromised people, studies are ongoing to explore any differences.

The JYNNEOS vaccine is safe and over 1.25 million doses of JYNNEOS have been administered in the U.S. since May 2022. A 2022 summary found that serious adverse events were rare in adults, and no serious adverse events have been identified in adolescents or children. CDC and FDA continue to monitor vaccine safety.

Provider Resources 

CDC JYNNEOS Vaccine Effectiveness 

It is important that communities most affected by mpox have access to timely, clear, and appropriate information, and a safe and effective mpox vaccine to prevent future outbreaks. In the 2022 mpox outbreak, gay, bisexual, and other men who have sex with men (MSM) make up most of the cases. Within this population, mpox cases are disproportionately higher among Black and Hispanic or Latino MSM and, in smaller numbers, Black and Hispanic or Latina women. Gender minorities, including transgender women and non-binary people, have also been disproportionately affected by mpox. 

Racial and ethnic disparities in mpox vaccination have also been described. A CDC MMWR from April 2023 described higher unmet vaccination need among racial and ethnic minority groups, particularly among Black and Hispanic males.

Provider Resources 

CDC Mpox Vaccine Equity Pilot Program 

VDH What Vaccines Do You Need? (table targeted to MSM and other sexually active people)

Healthcare providers should be aware of the groups of people recommended for mpox vaccination and the currently available vaccines. Providers who serve individuals at higher risk for mpox exposure are encouraged to become mpox vaccination providers. If a provider is unable to vaccinate, they may refer those eligible for vaccination to their local health department for vaccination or the CDC mpox vaccine locator tool to find the location closest to them.

Mpox screening, prevention, and treatment should be incorporated into routine sexual health and HIV care services to ensure all patients are assessed for risk factors, counseled on prevention measures, and assessed for further negative outcomes before the virus spreads. VDH’s Integrating Mpox into Sexual Health and HIV Care resource has more information.

Steps 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 specific groups that have a higher risk for exposure.

The JYNNEOS vaccine has been provided at no cost by the Federal Government since Summer 2022 in response to the mpox outbreak. As of April 2, 2024, JYNNEOS has started transitioning to the commercial market. This means that the vaccine will shift from the Strategic National Stockpile (SNS) to the commercial sector; this process will likely occur over several months.   

Sites may continue to order JYNNEOS through the Health Partner Ordering Portal (HPOP) through April 30, 2024. Ad hoc requests for JYNNEOS may be made until early-to-mid-August 2024 through HPOP and may be approved on a case-by-case basis. Private providers may also start purchasing JYNNEOS through their pharmaceutical wholesaler. Providers are prohibited from billing the cost of the vaccine for Federal Government supplied JYNNEOS, but are able to bill for the cost of administration.     

Local health departments should continue to order JYNNEOS through WebVision until VDH’s Division of Pharmacy Services through routine immunization ordering pathways. For questions, please email pharmacy@vdh.virginia.gov. 

If you wish to enroll as an mpox vaccination provider, please follow these steps : 

1. Review the Mpox Vaccination Program Provider Agreement to understand the requirements of mpox vaccine providers and prepare to attest to these requirements.
2. Providers need to pre-register in VERIP (Virginia Electronic Registration for Immunization Programs). An optional training video is below to provide instructions for how to pre-register. VERIP (Virginia Electronic Registration for Immunization Programs) Training Video 
3.  Email mpxquestions@vdh.virginia.gov to declare intent to order and administer the mpox vaccines in accordance with the Mpox Vaccination Program Provider Agreement requirements. Providers seeking to order mpox vaccines must enroll in the Health Partner Order Portal (HPOP). Steps to enroll in HPOP will be provided by email upon receipt of the declaration of intent to order and administer the mpox vaccines, in accordance with the HHS Provider Agreement requirements.
4. Review the following resources that may be adapted to fit your practice site:
   • VDH Vaccine Guide for Private Providers
   • CDC JYNNEOS Smallpox and Monkeypox Vaccine Preparation and Administration Summary (Intradermal)
   • VDH Vaccine Screening and Consent Form Template
   • CDC Standing Order for Subcutaneous Administration
   • CDC Standing Order for Intradermal Administration
   • CDC Information for Healthcare Professionals
   • CDC JYNNEOS Vaccine Intradermal Administration
   • Video: How To Do an Intradermal Injection
   • Administering Intradermal Injections
   • CDC Guidance for Planning Vaccination Clinics

All vaccine providers in Virginia must report any doses administered to the Virginia Immunization Information System (VIIS).

All vaccine waste must be reported in HPOP. Local Health Departments that do not have access to HPOP must report vaccine waste through the Mpox Vaccine & Medication Wastage (virginia.gov) survey. 

Providers should report any clinically significant adverse event following vaccination to the VAERS.

For VAERS questions, email info@VAERS.org, or call 1-800-822-7967 from Monday through Friday between 9 a.m. to 5 p.m. ET.