mpox Vaccine EUAs
On November 28, 2022, the World Health Organization announced, and the U.S. government supported, renaming monkeypox disease to mpox. In response to this action by the WHO, federal public health agencies will adopt the mpox name in correspondence with the medical community and American public from this point forward.
Effective August 9, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared:
- There is a public health emergency related to monkeypox, or significant potential for a public health emergency, that affects, or has the significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus; and
- On the basis of this determination, circumstances exist justifying the authorization of emergency use of vaccines.
Vaccine EUAs subsequently issued by FDA are listed in the table below.
PREP Act declaration: Effective September 28, 2022, the HHS Secretary amended the declaration first issued on October 10, 2008, and amended and republished effective January 1, 2016 for smallpox countermeasures and countermeasures against other orthopoxviruses pursuant to section 319F-3 of the Public Health Service Act to emphasize that the declaration applies to monkeypox virus, to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses in a declared emergency, and to extend the duration of the declaration. About PREP Act declarations
| Date of First EUA Issuance | Letter of Authorization (PDF) | Authorized Use | Fact Sheets and Manufacturer Instructions/Package Insert (PDF) | Additional Information and Decision Memoranda (PDF) |
|---|---|---|---|---|
| August 9, 2022 | Jynneos (602KB)Letter granting EUA amendment (August 16, 2022) (133KB) | Active immunization by subcutaneous injection for prevention of monkeypox disease in individuals less than 18 years of age determined to be at high risk for monkeypox infection, andActive immunization by intradermal injection for prevention of monkeypox disease in individuals 18 years of age and older determined to be at high risk for monkeypox infection. | Healthcare Providers (343KB) (updated August 16, 2022)Recipients and Caregivers (465KB)中文 (Chinese, Simplified)한국어 (Korean)Español (Spanish)Tagalog (Tagalog)Tiếng Việt (Vietnamese)Dear Healthcare Provider Letter (290KB) | Decision Memorandum (295KB) |
mpox In Vitro Diagnostics EUAs
Effective September 7, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared:
- On the basis of the August 9th determination, the Secretary of HHS has subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. See from HHS: HHS Secretary Becerra Issues 564 Declaration to Expand the Availability of Testing for Monkeypox
Diagnostic EUAs subsequently issued by FDA are listed in the table on this page: Monkeypox Emergency Use Authorizations for Medical Devices.
Additional information for product developers is available at:
- Policy for Monkeypox Tests to Address the Public Health Emergency
- Monkeypox Emergency Use Authorizations for Medical Devices (including EUA templates)
Note that FDA previously cleared real-time polymerase chain reaction (PCR) tests that detect non-variola orthopoxvirus DNA, including the virus that causes mpox. Learn more about these tests: Monkeypox Tests (In Vitro Diagnostic (IVD) Devices). Search:Show 102550100All entries
| Date of First EUA Issuance | Additional Information |
|---|---|
| September 7, 2022 | Monkeypox Emergency Use Authorizations for Medical Devices – Including a list of current medical device EUAs for mpox FAQs on Testing for Monkeypox – Answers to frequently asked questions relating to the development and performance of tests to detect the virus that causes mpox, primarily intended for test developersMonkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing (September 7, 2022) |
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On October 20, 2022, FDA also published lists of certain laboratories that have notified FDA of their laboratory developed monkeypox diagnostic test (LDT), modification to an FDA-cleared or EUA-authorized monkeypox diagnostic test, or laboratory developed monkeypox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox Tests to Address the Public Health Emergency. While FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency.
For additional information about monkeypox (mpox), see: FDA mpox Response and Monkeypox and Medical Devices.
Other Current EUAs
The tables below provide information on current EUAs:
- Anthrax EUAs
- Ebola Virus EUA Information
- Freeze Dried Plasma Information
- H7N9 Influenza EUA Information
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
- Nerve Agent EUA Information
- Zika Virus EUA Information
Information about EUAs that are no longer in effect is available on our EUA archive page.
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