#16,936
Yesterday, in FDA Issues EUA Allowing `Dose-sparing' Intradermal Injection Of JYNNEOS Monkeypox Vaccine, we looked at Tuesday's ruling by the FDA that - in order to increase the number of people who can be vaccinated by the currently limited supply of JYNNEOS vaccine - a dose-sparing intradermal vaccination technique can be used.
Today (Aug 11th) the CDC will hold a COCA call (at a special time 3:00 pm EST) to inform clinicians on this change, and to educate them on this procedure.
The CDC has also published updated guidance on the administration of Monkeypox vaccines (JYNNEOS and ACAM2000), which we'll look at after the COCA Call announcement.
I suspect this will be a heavily attended event.
As always, if you are unable to attend the live presentation, these (and past) webinars are archived and available for later viewing at this LINK.
CDC and FDA Update: Interim Clinical Considerations for Monkeypox Vaccination
“Please note special time of this COCA Call.”
Overview
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.
Presenters
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
Call Materials
Not available at this moment.
Call Details
When:
Thursday, August 11, 2022,
3:00 PM – 4:00 PM Eastern Time (US and Canada)
Webinar Link:
https://www.zoomgov.com/j/1613504249
Passcode: 181119
Telephone:
US: +1 669 254 5252
or +1 646 828 7666
or +1 669 216 1590
or +1 551 285 1373
International numbers
One-tap mobile:
US: +16692545252,,1613504249#,,,,*181119# or +16468287666,,1613504249#,,,,*181119#
Webinar ID: 161 350 4249
H.323/SIP room system:
H.323: 161.199.138.10 (US West) or 161.199.136.10 (US East)
Meeting ID: 161 350 4249
Passcode: 181119
SIP: 1613504249@sip.zoomgov.com
Passcode: 181119
Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak
Updated August 9, 2022
What You Need to Know
- The U.S. national monkeypox 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 monkeypox 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 monkeypox disease:
- JYNNEOS vaccine is approved for the prevention of monkeypox and smallpox disease.
- ACAM2000 vaccine is approved for immunization against smallpox disease and made available for use against monkeypox 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. In the context of the current national Public Health Emergency (PHE), an alternative regimen involving intradermal (ID) administration with an injection volume of 0.1mL may be used under an Emergency Use Authorization (EUA).
- People can be vaccinated after exposure to monkeypox virus to help prevent monkeypox disease (i.e., post-exposure prophylaxis).
- No data are currently available on the clinical efficacy or effectiveness of JYNNEOS or ACAM2000 vaccines in the current outbreak.
- 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 monkeypox.
- Globally and in the United States, supply of JYNNEOS vaccine is currently limited, although more is expected in the coming weeks and months. In the United States, there is a large supply of ACAM2000, but this vaccine has more 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 monkeypox 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 implies 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.
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