The JYNNEOS vaccine has been provided at no cost from the Federal Government since Summer 2022 in response to the mpox outbreak. As of April 1, 2024, JYNNEOS has started transitioning to the commercial market. See the Role of Healthcare Provider in the Mpox Vaccination Response section of this webpage for more information.
Cases of mpox peaked in August 2022, but the outbreak is not over. CDC continues to receive reports of cases that reflect ongoing community transmission in the U.S. and internationally, including multiple jurisdictions in the U.S. In early 2024, Virginia reported an increase in mpox cases.
CDC and VDH are urging clinicians to be on the alert for new cases of mpox (even if someone has been partially or fully vaccinated for mpox) and to encourage vaccination for people at risk.
Although vaccine-induced immunity is not complete, vaccination continues to be one of the most important prevention measures. CDC expects some new cases among previously vaccinated people to occur, but a recent CDC MMWR reported that infections after vaccination have been estimated to have occurred in fewer than 1% of fully vaccinated people. In addition, people who have completed their two-dose JYNNEOS vaccine series and then developed mpox have less severe symptoms and are less likely to be hospitalized than those who have not been vaccinated.
Mpox vaccination, testing, and treatment should be incorporated into routine care, including sexual health and HIV care services. CDC also has guidance to help with planning and implementation of satellite, temporary, and off-site vaccination clinics by public and private vaccination organizations. Resources include:
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
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 mpox vaccine locator 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.
Mpox cases in the United States continue to occur. They are less common than during the peak of the outbreak. 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. However, recent data indicate that immunity is not waning in people who received both vaccine doses. Booster doses are not currently recommended.
- 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 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
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
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
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 vaccine. 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.
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 1, 2024, JYNNEOS has started transitioning to the commercial market. Providers seeking to administer JYNNEOS should order JYNNEOS through their typical vaccine wholesaler.
For existing Mpox Vaccination Providers enrolled in the Health Partner Ordering Portal (HPOP), ad hoc requests for JYNNEOS may be made until July 30, 2024 at 12 p.m. ET through HPOP and may be approved on a case-by-case basis. 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. For questions, please email pharmacy@vdh.virginia.gov.
At this time, JYNNEOS is not available on the CDC contract to be able to purchase for Vaccines For Children (VFC)/Vaccines for Adults (VFA)/317 Vaccine programs. We anticipate the vaccine will be added to the contract in Fall 2024. For questions, please email vvfc@vdh.virginia.gov.
Insurance Coverage and Payment
- Medicare and Medicaid beneficiaries are expected to have full coverage for ACIP recommendations, including JYNNEOS.
- Private insurance beneficiaries are expected to have full coverage for ACIP recommendations. Private insurers have one year after ACIP recommendation to include coverage in plans.
- Individuals without insurance should inquire with their local health department to determine eligibility for JYNNEOS through the VFC/VFA/317 programs.
Resources
- 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
- CDC Guidance for Planning Vaccination Clinics
All vaccine providers in Virginia must record any doses administered into 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 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.
Page updated: July 10, 2024
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