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FDA Mpox Response

FDA's role in mpox preparedness and response, and information about mpox (formerly referred to as monkeypox)

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Image of Monkeypox virus
Note: On November 28, 2022, The World Health Organization announced the name “mpox” is to replace what was previously referred to as “monkeypox.” This site has been updated to reflect this change, while some material created prior to the change may still reflect the old name.

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    FDA’s Role  

    The U.S. Food and Drug Administration plays a critical role in protecting the U.S. from chemical, biological, radiological, nuclear (CBRN) attacks, and emerging infectious disease threats.

    The FDA's roles in mpox preparedness and response include:

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    Latest mpox Information from the FDA

    Date Update Type Topic
    March 17, 2023 The FDA issued an emergency use authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test for use in a point-of-care setting. It is a molecular-based test intended to detect the virus DNA in lesion swab specimens from individuals suspected of mpox by their healthcare provider. Press Release/Public Statement Medical Devices
    February 22, 2023 The FDA approved a shelf-life extension of TPOXX (tecovirimat) Injection, 200 mg, from 24 months to 42 months for some lots of TPOXX injection. TPOXX supplied by the Strategic National Stockpile (SNS) does not have an expiration date printed on its label. To determine the expiration date for product received from the SNS, find the lot number on the product label and refer to this table to identify the corresponding expiration date. Press Release/Public Statement Biologics; Drugs
    February 10, 2023 The FDA issued an emergency use authorization (EUA) for the Cepheid Xpert Mpox test for use in a point-of-care setting. Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program established as a collaboration between the FDA and the NIH. The Xpert Mpox test is a real-time polymerase chain reaction (PCR) test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider. Press Release/Public Statement Medical Devices
    January 31, 2023 The U.S. mpox public health emergency ended. Statement From HHS Secretary Becerra on end of mpox public health emergency. Monkeypox Update Public Information
    January 30, 2023 The FDA issued warning letters to five companies illegally selling products that claim to cure, treat, mitigate, or prevent human mpox infection. Safety Information Warning Letters
    January 20, 2023 The FDA announced the availability of a draft guidance, Mpox: Development of Drugs and Biological Products. The draft guidance provides the FDA’s current thinking regarding nonclinical, virology, and clinical considerations for mpox drug development programs. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of mpox. Comments and suggestions regarding this draft guidance should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Press Release/Public Statement Biologics; Drugs
    January 10, 2023 The FDA issued an Emergency Use Authorization (EUA) to DiaCarta, Inc. for the QuantiVirus MPXV Test Kit for the qualitative detection of DNA from mpox virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Press Release/Public Statement Medical Devices
    December 23, 2022 The FDA issued an Emergency Use Authorization (EUA) to Beckton, Dickinson and Company for the VIASURE Monkeypox [mpox] virus Real Time PCR Reagents for BD MAX System for the qualitative detection of DNA from mpox virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Press Release/Public Statement Medical Devices
    December 13, 2022 The FDA issued an Emergency Use Authorization (EUA) to Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.) for the TaqPath Monkeypox [mpox]/Orthopox Virus DNA Kit for the qualitative detection of DNA from mpox virus and non-variola orthopoxvirus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Press Release/Public Statement Medical Devices
    November 29, 2022

    The FDA posted the following templates with recommendations on what to include in Emergency Use Authorization (EUA) requests or Pre-EUA submissions for mpox antigen tests. The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.

    Press Release/Public Statement Medical Devices
    November 15, 2022 The FDA issued an Emergency Use Authorization (EUA) to Roche Molecular Systems, Inc. for the cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (EUA220459) for the qualitative detection of DNA from mpox virus in human lesion swab specimens from individuals suspected of mpox virus infection by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests. Press Release/Public Statement Medical Devices
    October 31, 2022 The FDA launched a new web-based application for single-patient emergency use IND requests for Tembexa, a therapeutic option for patients with human mpox disease who meet specific eligibility criteria. Additional information about Tembexa is available here. Press Release/Public Statement Biologics; Drugs; Medical Devices
    October 20, 2022

    The FDA updated its mpox and Medical Devices page to provide lists of certain laboratories that have notified FDA of their laboratory developed mpox diagnostic test, modification to an FDA-cleared or EUA-authorized mpox diagnostic test, or laboratory developed mpox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox [mpox] 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.

    Press Release/Public Statement Medical Devices
    October 7, 2022 The FDA issued an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect mpox DNA using lesion swab specimens from individuals suspected of mpox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of mpox. The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests.  Press Release/Public Statement Medical Devices
    September 7, 2022 Monkeypox [mpox] Update: FDA Takes Significant Action to Help Expand Access to Testing Press Release/Public Statement Medical Devices
    September 7, 2022

    The FDA published new web pages about mpox and medical devices, including diagnostic testing, and authorized the first Emergency Use Authorization (EUA) for a mpox in vitro diagnostic. 

    Press Release/Public Statement Medical Devices
    August 9, 2022 Monkeypox [mpox] Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply Press Release/Public Statement Biologics
    August 4, 2022 Biden-Harris Administration Bolsters Monkeypox [mpox] Response; HHS Secretary Becerra Declares Public Health Emergency. Monkeypox Update Public Information
    August 3, 2022 Tecovirimat and the Treatment of Monkeypox [mpox] – Past, Present, and Future Considerations Press Release/Public Statement Drugs
    July 29, 2022 FDA Provides Update on Agency Response to Monkeypox [mpox] Outbreak Monkeypox Update Biologics; Drugs; Medical Devices
    July 26, 2022 The FDA approved a supplement to the biologics license for the JYNNEOS Vaccine, which is approved to prevent smallpox and mpox, to allow for additional manufacturing capabilities at one of the plants where the vaccine is made. After expediting and completing an inspection of the plant earlier this month, the FDA has finished its evaluation of the required information to validate product quality and determined that the vaccine meets its quality standards. Press Release/Public Statement Biologics
    July 15, 2022 The FDA is advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the mpox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for mpox virus testing. Testing samples not taken from a lesion may lead to false test results. Safety Information Medical Devices
    June 24, 2022 The FDA cleared the CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221834) for use in CDC-designated laboratories. Press Release/Public Statement Medical Devices
    June 10, 2022 The FDA cleared the use of additional reagents and automation to increase testing capacity of laboratories using the CDC test. Press Release/Public Statement Medical Devices

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    Fast Facts

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    Vaccines

    The FDA approved JYNNEOS Vaccine in 2019, for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection.

    • This is the only currently FDA-approved vaccine for the prevention of mpox disease. 
    • The vaccine does not contain the viruses that cause smallpox or mpox. 
    • Given the emerging public health need, the FDA and government partners worked to accelerate submission of information needed to make additional U.S. doses of JYNNEOS available much more quickly than scheduled.  
    • The vaccine is part of the Strategic National Stockpile, overseen by the Department of Health and Human Services’ Assistant Secretary for Preparedness and Response, which helps ensure that the vaccine is accessible in the U.S. if needed.

    For more information, see: FDA Fast Facts: JYNNEOS, Korean, Simplified Chinese, Spanish, Tagalog, Vietnamese

    For more information on the intradermal Jynneos vaccine, see: Intradermal JYNNEOS Monkeypox [mpox] VaccineSimplified ChineseKoreanTagalogVietnameseSpanish

    For more information on mpox vaccines available under Emergency Use Authorization, see: mpox Vaccine EUAs

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    Therapeutics  

    There are no FDA-approved treatments for human mpox. However, there are medicines that may potentially treat human mpox, which are only available through clinical trial(s) or under the FDA’s Expanded Access program, often referred to as “compassionate use”.

    TPOXX (tecovirimat) and Tembexa (brincidofovir) are antivirals which were approved to treat smallpox based on the FDA’s Animal Rule regulations, which provide a pathway for approval of certain drugs and biological products when it is not ethical or feasible to conduct efficacy studies in humans, for example, in the case of smallpox where the disease has been eradicated (21 CFR 314.600-650 and 21 CFR 601.90-95). Under the Animal Rule, adequate and well-controlled animal studies can establish the drug or biological product is reasonably likely to produce clinical benefit in humans. The Animal Rule is not a viable regulatory pathway to approve drugs for the treatment of mpox as it has been both feasible and ethical to conduct clinical trials in humans since tecovirimat was first approved as a treatment for smallpox. 

    TPOXX (tecovirimat):

    In 2018, the FDA approved TPOXX for treatment of smallpox in adults and children under the Animal Rule. Approval was based on efficacy data obtained from animal studies, specifically non-human primates infected with mpox virus and rabbits infected with rabbitpox virus. Such studies were relevant since the viruses that cause smallpox, mpox, and rabbitpox are in the same family of viruses called “orthopoxviruses.” Safety data was obtained in healthy human volunteers administered TPOXX. 

    The safety and efficacy of TPOXX for the treatment of human mpox has not been established. Conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with mpox infections is essential. We do not currently know if TPOXX will be beneficial in treating patients with mpox, since drugs that are effective in animal studies are not always effective in humans. 

     

    Tembexa (brincidofovir)

    In 2021, the FDA approved Tembexa for treatment of smallpox in adults and children, including neonates, under the Animal Rule. Approval was based on efficacy data obtained from animal studies, specifically rabbits infected with rabbitpox virus and mice infected with ectromelia virus. These viruses are in the same family of viruses, called “orthopoxviruses,” as smallpox and mpox. Safety data was obtained from clinical trials of Tembexa for a non-smallpox indication, primarily from patients who received bone marrow transplants. 

    The safety and efficacy of Tembexa to treat mpox in humans has not been established. In a trial evaluating Tembexa versus placebo for the prevention of cytomegalovirus infection in bone marrow transplant recipients, an increased risk of death was seen in patients treated with Tembexa for a longer duration than that recommended in the US product labeling for the treatment of smallpox. Other safety issues include liver toxicity, risk of birth defects, risk of cancer, and risk of male infertility. The most common side effects when using Tembexa are diarrhea, nausea, vomiting, and abdominal pain. Please refer to the US prescribing information for Tembexa for additional information on Tembexa’s safety profile. 

    For more information: FDA Fast Facts: TPoxx, Korean, Simplified Chinese, Spanish, Tagalog, Vietnamese 
    Also see: Smallpox therapeutic information from the FDA.

    For FDA Center for Drug Evaluation and Research (CDER) therapeutic product development questions, please contact: CDERPublicHealthEmergencyProductDevelopment@fda.hhs.gov.

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    Mpox and medical devices

    Mpox virus diagnostic tests are used to determine if a person is infected with the virus that causes mpox. They may detect the mpox virus specifically or more generally detect non-variola orthopoxviruses, which includes mpox virus.  

    Information on Emergency Use Authorizations (EUAs) for in vitro diagnostics that the FDA has issued related to mpox to address the public health emergency is available on the mpox EUAs web page. 

    Additional information on mpox devices, including FDA-cleared and EUA-authorized tests, as well as more detailed information for test developers and health care providers, can be found at mpox and Medical Devices and FAQs on Testing for mpox

    If you suspect you had an adverse event or other problem with a medical device, please report it using the FDA’s MedWatch Online Voluntary Reporting Form

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    Fraud and Misinformation 

    Unfortunately, during emergency situations, fraudulent products claiming to prevent, treat or cure conditions associated with the emergency almost always appear for sale. The FDA monitors for fraudulent products and false product claims related to emerging infectious disease threats and takes appropriate action to protect consumers.

    You can report a fraudulent mpox product to the FDA. The page includes options for phone and online reporting in English or en Español.

    You can find a list of fraudulent mpox products at the FDA’s Illegally Sold Mpox Products webpage.

    Moreover, the FDA has taken significant steps to combat misinformation about FDA-regulated products being communicated online, in the news, and by high-profile public officials, celebrities, and other outlets. We continue to look for opportunities to combat misinformation head-on in ways easy for consumers to understand and communicate the potential for real harm. Find trusted health information from the FDA and our government partners. See the resources below.

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    Additional Resources

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    Contact the FDA 

    Consumers and general information: contact FDA
    You may also call 1-888-INFO-FDA / (1-888-463-6332)

    For CDER therapeutic product development questions, please contact: CDERPublicHealthEmergencyProductDevelopment@fda.hhs.gov

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    • 11Due to the conserved nature of VP37, tecovirimat resistance-associated substitutions in one orthopoxvirus are expected to apply to other orthopoxviruses.
     

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