CDC and FDA Update: Interim Clinical Considerations for Monkeypox Vaccination

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the JYNNEOS vaccine. The EUA allows healthcare providers to administer the vaccine by intradermal injection for individuals 18 years of age and older who are at high risk for monkeypox infection, which will result in up to a five-fold increase in the total number of doses available for use. In addition, the Centers for Disease Control and Prevention (CDC) has released Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak that provides guidance for using the alternative (intradermal) regimen, as well as the standard (subcutaneous) regimen for JYNNEOS vaccine.

During this COCA Call, presenters from FDA and CDC will provide updates on FDA’s EUA of the JYNNEOS vaccine and CDC’s Interim Clinical Considerations for using the JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak. Presenters will also provide training on how to administer the vaccines using the interim clinical considerations.

Jennifer McQuiston, DVM, MS
CAPT, U.S. Public Health Service
Incident Manager
2022 Multinational Monkeypox Response
Centers for Disease Control and Prevention

Peter Marks, MD, PhD
Director, Center for Biologics Evaluation and Research
U.S. Food & Drug Administration

Elissa Meites, MD, MPH
CAPT, U.S. Public Health Service
Vaccine Team, Clinical Task Force
2022 Multinational Monkeypox Response
Centers for Disease Control and Prevention

Elisabeth (Liz) Velazquez, RN, BSN, COHN-S
Nurse Educator, Clinical Education Lead
Vaccine Team, Clinical Task Force
2022 Multinational Monkeypox Response
Centers for Disease Control and Prevention