Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Mpox Outbreak
Table of Contents
- Updated to note that providers may discuss with patients to determine which route of administration each patient prefers
- Updated guidance on Components of the U.S. National Vaccination Strategy Used in the U.S. Mpox Outbreak
- Updated guidance on Intradermal (ID) Administration of the JYNNEOS vaccine (Alternative Regimen)
- Updated guidance in Vaccination Schedule and Dosing Regimens for JYNNEOS Vaccine for people younger than age 18 years
- Updates to Coadministration of JYNNEOS vaccine with tuberculin skin test
- Updated Contraindications and Precautions for Use of ACAM2000 Vaccine (Table 5)
- Updated guidance on JYNNEOS and ACAM2000 Vaccination Administration Considerations for Specific Populations (Table 6)
- Updated Vaccine Administration Errors and Deviations (Table 7)
What You Need to Know
- The U.S. national mpox vaccine strategy was announced on June 28, 2022. Multiple federal agencies, including the Administration for Strategic Preparedness and Response (ASPR), U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and Centers for Disease Control and Prevention (CDC) are coordinating to implement this enhanced vaccination strategy.
- This document provides interim guidance regarding use of JYNNEOS and ACAM2000 vaccines during the mpox outbreak that began in the United States on May 17, 2022. This interim guidance is in addition to standard guidance and recommendations for use of these vaccines from CDC’s Advisory Committee on Immunization Practices (ACIP).
- Two vaccines may be used for the prevention of mpox disease:
- JYNNEOS vaccine is approved for the prevention of mpox and smallpox. During the current outbreak, JYNNEOS is the main vaccine being used in the United States.
- ACAM2000 vaccine is approved for immunization against smallpox and made available for use against mpox under an Expanded Access Investigational New Drug (EA-IND) protocol.
- 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).
- Either the standard (0.5mL SubCut) or the alternative (0.1mL ID) regimen may be used. Providers may discuss with patients to determine which route of administration each patient prefers.
- People may be vaccinated after exposure to mpox virus to help prevent mpox disease (i.e., post-exposure prophylaxis).
- People who are at higher potential for exposure to mpox virus may be offered vaccination to help prevent mpox disease (i.e., pre-exposure prophylaxis).
- No data are currently available on the clinical efficacy or effectiveness of JYNNEOS or ACAM2000 for mpox disease. Limited data on performance of JYNNEOS vaccine in the current outbreak are becoming available. Across 32 U.S. jurisdictions, among males aged 18–49 years eligible for JYNNEOS vaccination, mpox incidence was 14 times as high among unvaccinated males compared with those who had received a first vaccine dose ≥14 days earlier
- Because there are limitations in our knowledge about the effectiveness of these vaccines in the current outbreak, 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.
- In the United States, there is a large supply of ACAM2000, but this vaccine has more known side effects and contraindications.
Purpose and Scope
This document provides interim guidance for healthcare professionals and public health officials regarding use of JYNNEOS and ACAM2000 vaccines during the mpox outbreak that began in the United States on May 17, 2022. Considerations apply only to the use of vaccine products in the United States. This interim guidance is in addition to existing standard guidance and recommendations for use of these vaccines from CDC’s Advisory Committee on Immunization Practices (ACIP).
Considerations presented in this document are interim guidelines, which are developed in response to emergencies, such as outbreaks and natural or manmade disasters. The term “interim” indicates that CDC developed these guidelines using either expert opinion, indirect evidence, or emerging evidence, and these recommendations might change when additional evidence becomes available. This document is informed by data and considerations from U.S. federal agencies including ASPR, FDA, NIH, and CDC, general best practice guidelines for immunization, other data sources, and expert opinion.
- JYNNEOS Package Insert
- JYNNEOS Vaccine Information Statement (VIS) [151 KB, 2 pages]
- JYNNEOS Vaccine Information Statement (VIS) in Spanish [165 KB, 2 pages]
- Vaccine Storage and Handling Toolkit [70 pages]
- JYNNEOS Standing Orders (Standard Regimen) [233 KB, 3 pages]
- JYNNEOS Standing Orders (Alternative Regimen) [243 KB, 3 pages]
- JYNNEOS Preparation and Administration Summary (Standard Regimen) [134 KB, 3 pages]
- JYNNEOS Preparation and Administration Summary (Alternative Regimen) [139 KB, 3 pages]
- Animated Video: How to administer a JYNNEOS vaccine intradermally (no audio)
- Video: Administering JYNNEOS Intradermally
- Images: Administering JYNNEOS Intradermally [ZIP – 32 MB]
- ACAM 2000 Medication Guide
- Vaccination Operational Planning Guide
- FDA EUA Fact Sheet for Providers [900 KB, 16 pages]
- FDA EUA Fact Sheet for Patients and Caregivers [465 KB, 5 pages]
- FDA EUA Fact Sheet for Patients and Caregivers in Other Languages
- Mpox Vaccination Program Provider Agreement
- JYNNEOS Smallpox and Mpox Vaccine: Patient Screening Form [227 KB, 3 pages]