Vaccine for Mpox Prevention in the United States

Overview

People at risk of mpox should ideally be vaccinated prior to exposure to Monkeypox virus (MPXV). People may be vaccinated after exposure to MPXV to help prevent mpox (i.e., post-exposure prophylaxis).

People may be vaccinated after exposure to MPXV to help prevent mpox (i.e., post-exposure prophylaxis).

Two vaccines may be used for the prevention of mpox:

• JYNNEOS vaccine is approved and recommended by CDC and ACIP for the prevention of mpox and smallpox. During the ongoing clade II MPXV outbreak (i.e., outbreak that began in 2022 affecting predominantly gay, bisexual, and other men who have sex with men), JYNNEOS has been the main vaccine used in the United States.

• ACAM2000 vaccine is approved for immunization against smallpox and could be made available for use against mpox under an Expanded Access Investigational New Drug (EA-IND) protocol. In the United States, there is a large supply of ACAM2000, but this vaccine has more known side effects and contraindications. As ACAM2000 has not been used during the ongoing clade II mpox outbreak, resources related to ACAM2000 for the mpox outbreak have been archived. ACAM2000 resources remain available on smallpox webpages.

The standard regimen for JYNNEOS involves a subcutaneous (subcut) route of administration with an injection volume of 0.5mL. An alternative regimen involving intradermal (ID) administration with an injection volume of 0.1mL may be used under an Emergency Use Authorization (EUA).

• Both the standard (0.5mL subcut) and the alternative (0.1mL ID) regimen have been found to be effective for mpox prevention.
• There is adequate supply of JYNNEOS vaccine. Therefore, clinicians can preferentially administer JYNNEOS via the subcutaneous route.

JYNNEOS vaccine is licensed as a series of two doses administered 28 days (4 weeks) apart.

For people with sexual risk factors for mpox who have not been diagnosed with mpox during the ongoing outbreak or have not already received 2 doses of the JYNNEOS vaccine, CDC routinely recommends vaccination.

People who are 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 mpox.

*Research laboratory personnel are those who directly handle cultures or animals contaminated or infected with monkeypox virus (MPXV). Vaccination is not routinely recommended for clinical laboratory personnel who perform routine chemistry, hematology, and urinalysis testing, including for patients with suspected or confirmed MPXV infection, healthcare personnel who care for patients with mpox or administer ACAM2000. Recommended infection prevention and control practices are effective in minimizing transmission. Vaccination can be offered based on site- and activity- specific biosafety risk assessments (e.g., identification of laboratory procedures with a high likelihood of generating aerosols or inadequate PPE availability).

Commercialization

• On April 1, 2024, Bavarian Nordic commercially launched their JYNNEOS vaccine. See the HHS Mpox Vaccine Operational Planning Guide for more information.
• The cost of JYNNEOS vaccine and vaccine administration may be covered by some health insurance plans. Learn more about coverage policies for Medicaid, CHIP, Medicare, VA, TRICARE, and private or commercial insurance.
• Federal agencies are working to incorporate JYNNEOS vaccine into their programs to support broad access to this vaccine, including among people who are uninsured and underinsured.

Resources

• JYNNEOS Package Insert
• JYNNEOS Vaccine Information Statement (VIS)
• JYNNEOS Vaccine Information Statement (VIS) in Spanish
• Vaccine Storage and Handling Toolkit
• JYNNEOS Standing Orders (Standard Regimen)
• Vaccination Operational Planning Guide
• FDA EUA Fact Sheet for Providers
• FDA EUA Fact Sheet for Patients and Caregivers
• FDA EUA Fact Sheet for Patients and Caregivers in Other Languages