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Colorized scanning electron micrograph of monkeypox virus (orange) on the surface of infected VERO E6 cells (green). (Credit: NIAID)


FDA’s Role | What’s New | Fast Facts | Vaccines | Therapeutics |  Monkeypox and medical devices |  Fraud and Misinformation | Contact the FDA |  Additional Resources

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 monkeypox preparedness and response during this public health emergency include:

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What’s New

  • 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 monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox 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.
  • 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 monkeypox disease who meet specific eligibility criteria. Additional information about Tembexa is available here.
  • October 20, 2022: FDA updated its Monkeypox and Medical Devices page to provide lists of certain laboratories that have notified FDA of their laboratory developed monkeypox diagnostic test, 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.
  • 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 monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox. 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. 
  • September 7, 2022: Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing
  • September 7, 2022: FDA published new web pages about monkeypox and medical devices, including diagnostic testing, and authorized the first Emergency Use Authorization (EUA) for a monkeypox in vitro diagnostic. 
  • August 9, 2022: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply
  • August 3, 2022: Tecovirimat and the Treatment of Monkeypox – Past, Present, and Future Considerations
  • July 29, 2022: FDA Provides Update on Agency Response to Monkeypox Outbreak
  • July 26, 2022: The FDA approved a supplement to the biologics license for the JYNNEOS Vaccine, which is approved to prevent smallpox and monkeypox, 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.
  • July 15, 2022: The FDA is advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. Testing samples not taken from a lesion may lead to false test results.
  • 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.
  • June 10, 2022: The FDA cleared the use of additional reagents and automation to increase testing capacity of laboratories using the CDC test.

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Fast Facts

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

  • This is the only currently FDA-approved vaccine for the prevention of monkeypox disease. 
  • The vaccine does not contain the viruses that cause smallpox or monkeypox. 
  • 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.
  • Get the Fast Facts on the Intradermal JYNNEOS Monkeypox VaccineSimplified ChineseKoreanTagalogVietnameseSpanish

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

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There are no FDA-approved treatments for human monkeypox. However, there are medicines that may potentially treat human monkeypox, 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 monkeypox 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 monkeypox virus and rabbits infected with rabbitpox virus. Such studies were relevant since the viruses that cause smallpox, monkeypox, 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 monkeypox has not been established. Conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential. We do not currently know if TPOXX will be beneficial in treating patients with monkeypox, 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 monkeypox. 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 monkeypox 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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Monkeypox and medical devices

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

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

Additional information on monkeypox 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 Monkeypox and Medical Devices and FAQs on Testing for Monkeypox

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 monkeypox product to the FDA. The page includes options for phone and online reporting in English or en Español.

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

FDA’s Role | What’s New | Fast Facts | Vaccines | Therapeutics |  Diagnostics |  Fraud and Misinformation | Contact the FDA |  Additional Resources


  • 1. 1Due to the conserved nature of VP37, tecovirimat resistance-associated substitutions in one orthopoxvirus are expected to apply to other orthopoxviruses.


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