About
- Monkeypox vaccines are expected to be protective against Monkeypox virus regardless of clade.
- JYNNEOS vaccine is approved and recommended for the prevention of monkeypox.
- People at risk for monkeypox or who have been exposed to the virus that causes monkeypox are recommended for vaccination.
Overview
People at risk for monkeypox should ideally be vaccinated prior to exposure to Monkeypox virus (MPXV). People may be vaccinated after exposure to MPXV to help prevent monkeypox (i.e., post-exposure prophylaxis).
People may be vaccinated after exposure to MPXV to help prevent monkeypox (i.e., post-exposure prophylaxis).
Two vaccines may be used for the prevention of monkeypox:
- JYNNEOS vaccine is approved and recommended by CDC and ACIP for the prevention of monkeypox 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 monkeypox 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been used during the ongoing clade II monkeypox outbreak, resources related to ACAM2000 for the monkeypox outbreak have been archived.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 monkeypox 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 monkeypox who have not been diagnosed with monkeypox 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 monkeypox.
*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 monkeypox 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).
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)
- 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
- Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC)
- Vaccine approval (licensure) under a Biologics License Application (BLA) or authorization under an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)
- ACIP's General Best Practice Guidelines for Immunization