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:
- The FDA facilitates development and availability of medical products that can be used to diagnose, prevent, or treat mpox.
- The FDA works closely with product sponsors to clarify regulatory and data requirements necessary to rapidly advance development and availability of medical products essential to supporting response efforts.
- The FDA uses appropriate regulatory mechanisms to expedite access to medical products, such as under expanded access when circumstances warrant.
- The FDA also works with product sponsors and the scientific community to design efficient, well controlled trials to support the regulatory evaluation of investigational products.
- The FDA monitors for fraudulent products and false product claims related to CBRN and emerging infectious disease threats and takes appropriate action to protect consumers.
|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|January 20, 2023||The FDA announced the availability of a draft guidance, Mpox: Development of Drugs and Biological Products. The draft guidance provides the FDA’s current thinking regarding nonclinical, virology, and clinical considerations for mpox drug development programs.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 Comments and suggestions regarding this draft guidance should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.||Press Release/Public Statement||Biologics; Drugs|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||Drug|
|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|
mpox is a rare disease that is caused by infection with mpox virus. This virus can spread to anyone through close, personal, often skin-to-skin contact. Currently, a high rate of the known cases in the U.S. are among gay and bisexual men and transgender and non-binary people, but this virus is not limited by sexuality or gender.
Please see the Centers for Disease Control and Prevention’s page 2022 United States Monkeypox [mpox] Response for the latest response information.
At this time, public health authorities have not recommended the general public needs to be vaccinated against mpox. Public health authorities have only recommended select individuals receive vaccination. For example, vaccination is recommended for those who have been exposed to mpox and for individuals with certain risk factors. Refer to the CDC’s recommendations, Considerations for Monkeypox [mpox] Vaccination, for specific information.
Individuals who received a smallpox vaccine may have some protection against mpox. However, there are several factors that could affect whether immunity was actually present, including the “take” (the lesion that develops at the site of inoculation) of the vaccine when administered and the time since vaccination.
Yes. Moreover, since mpox was first detected in the U.S., the FDA is working closely with the CDC, commercial laboratories, and traditional manufacturers to make mpox tests more readily available to patients and providers.
There is only one FDA-cleared test, the CDC’s Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221834), for use in CDC-designated laboratories and it uses swab samples taken directly from a lesion (rash or growth). The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for mpox virus testing.
There are no FDA-approved treatments for mpox. However, the CDC holds an expanded access Investigational New Drug (EA-IND) protocol, sometimes called “compassionate use,” that allows for use of an antiviral medication called TPOXX (tecovirimat) for treatment of mpox. The safety and efficacy of TPOXX to treat mpox in humans has not been established.
Expanded access is a pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or alternative therapy options are available. For more information, please see FDA’s website at: https://www.fda.gov/news-events/public-health-focus/expanded-access.
At this time, the CDC is not aware of any mpox cases in the current outbreak that have been associated with handling or eating food.
In general, you should wash your hands after handling food packaging, after removing food from the packaging, before you prepare food for eating, and before you eat. Consumers can follow the CDC guidelines on frequent hand washing with soap and water for at least 20 seconds; and frequently clean and disinfect surfaces.
- It is always important to follow the four steps of food safety—clean, separate, cook, and chill.
mpox can spread to anyone through close, personal, often skin-to-skin contact, including:
- Direct contact with mpox rash, scabs, or body fluids from a person with mpox.
- Touching objects, fabrics (clothing, bedding, or towels), and surfaces that have been used by someone with mpox.
- Contact with respiratory secretions.
For more information, see: How it Spreads | Monkeypox [mpox] | Poxvirus | CDC
A person with mpox can spread it to others from the time symptoms start until the rash has fully healed and a fresh layer of skin has formed. The illness typically lasts 2-4 weeks. The CDC recommends that people with mpox remain isolated at home or at another location for the duration of illness.
mpox can be spread by touching objects, fabrics (clothing or towels), and surfaces that have been used by someone with mpox.
Anyone handling, preparing and serving food should always follow safe food handling procedures, such as washing hands and surfaces often.
For more information, see: How it Spreads | Monkeypox [mpox] | Poxvirus | CDC
Signs and Symptoms | Monkeypox [mpox] | Poxvirus | CDC
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.
- Get the Fast Facts on the Intradermal JYNNEOS Monkeypox [mpox] Vaccine, Simplified Chinese, Korean, Tagalog, Vietnamese, Spanish
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.
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.
In September 2022, the National Institute of Allergy and Infectious Diseases opened a randomized, controlled clinical trial to assess the safety and efficacy of TPOXX for the treatment of mpox infection. Health care providers should encourage their patients with mpox infection to be evaluated for enrollment in this trial. For patients for whom enrollment in this trial is not feasible (e.g., a clinical trial site is not geographically accessible), use of tecovirimat under CDC’s expanded access protocol (EA-IND) should be consistent with CDC’s guidelines for tecovirimat use. The FDA facilitates development and availability of medical products that can be used to diagnose, prevent, or treat mpox.
Viruses can change over time. Sometimes these changes make antiviral drugs less effective at combating the virus they are targeting, meaning those drugs won’t work as well or might not work at all.
TPOXX works by inhibiting a viral protein, called VP37, that all orthopoxviruses (e.g., smallpox virus, mpox virus, vaccinia virus) share. However, as noted in the drug label, TPOXX has a low barrier to viral resistance. This means small changes to the VP37 protein could have a large impact on the antiviral activity of TPOXX.
CDC scientists are actively monitoring for changes in the mpox virus that could make the virus less susceptible to TPOXX. Because of the potential for the virus to become resistant to TPOXX, it is important the drug be used in a judicious manner.
On September 12, 2022, the FDA released additional information in publicly posted reviews supporting approval of the new drug application for tecovirimat to describe specific changes in the VP37 proteins of orthopoxviruses (e.g., vaccinia virus and mpox virus) that are associated with tecovirimat drug resistance.
As described in the FDA reviews, multiple independent studies characterized tecovirimat resistance development in orthopoxviruses in cell culture studies, in animal studies, and in an anecdotal human case of progressive vaccinia. These studies identified several genetic pathways for orthopoxviruses to become resistant to tecovirimat, which involves the emergence of amino acid substitutions in the viral VP37 drug target (see Table below). Many of the resistance pathways require only a single amino acid change in VP37 to cause a substantial reduction in tecovirimat antiviral activity.
Table: Orthopoxvirus VP37 Amino Acid Substitutions Associated with Tecovirimat Resistance
|Resistance Analysis Study||Amino Acid Substitutions|
|VP37 amino acid substitutions associated with high-level phenotypic resistance to tecovirimat in cell culture (defined as ≥10-fold increase in EC50 value) in vaccinia virus, cowpox virus or camelpox virus
Single amino acid substitutions: H238Q, N267D/S, G277C, D283G/Y, A290V, D294V, A295E, L302P/Q
Combinations of amino acid substitutions: F25V+I372N, L178S+Y258C, N179H+D283G, H194N +303insSVK, N267D+I309T, N267S+I317V, G277C+I372N, D280G+D294G, A290V+L315M, K68N+Y258C+T308S, W2C+D225A+Y258C+D280G
|VP37 amino acid substitutions detected in mpox virus infected, tecovirimat-treated nonhuman primates that succumbed to disease||H238Q, N267del/I/D/S/K, R268G, D280Y, A290V, A295E, L297ins, I372N/ILKIKNRK (mutation of stop codon and extension of reading frame)
|VP37 amino acid substitutions detected in a tecovirimat-treated individual with progressive vaccinia virus infection
|1Due to the conserved nature of VP37, tecovirimat resistance-associated substitutions in one orthopoxvirus are expected to apply to other orthopoxviruses.|
Collectively, these studies indicate tecovirimat has a low barrier to resistance, and this must be considered in the context of the current mpox public health emergency because there is a risk that tecovirimat resistant virus could emerge and possibly spread.
The FDA is releasing this information to aid the scientific community’s genomic sequencing efforts to support national surveillance of the current mpox virus outbreak in the U.S. The FDA believes releasing this additional information will further facilitate the ability to monitor for the development and spread of tecovirimat-resistant virus and therefore is important in promoting public health.
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.
Brincidofovir can be accessed by submitting a single-patient emergency use IND (EIND) request to the FDA. Brincidofovir can be considered for use under an EIND for treatment of human mpox disease in adults and pediatric patients (including neonates) with positive results of human mpox viral testing who:
- have severe disease OR are at high risk for progression to severe disease,
- AND meet either of the following:
- experience clinically significant disease progression while receiving tecovirimat or
- who develop recrudescence (initial improvement followed by worsening) of disease after an initial period of improvement on tecovirimat, OR
- are otherwise ineligible or have a contraindication for oral or intravenous (IV) tecovirimat.
Clinicians with mpox patients for whom brincidofovir may be appropriate need to submit an EIND request to FDA. This can be done multiple ways. An electronic application that can be completed on a phone or computer allows for submission of an EIND to FDA at any time. This eRequest application can be found on the Reagan-Udall Foundation for the FDA website. EIND requests may also be submitted by email (DDI.EIND@fda.hhs.gov) or by phone 301-796-3400 or 1-855-543-3784 during normal business hours (8 am-4:30 pm ET M-F). After 4:30 p.m. ET weekdays and all day on weekends/holidays, call the FDA Emergency Coordinator at 1-866-300-4374 or 301-796-8240 or email CDER-EIND@fda.hhs.gov and call the CDER Emergency Coordinator at 301-796-9900.
For FDA Center for Drug Evaluation and Research (CDER) therapeutic product development questions, please contact: CDERPublicHealthEmergencyProductDevelopment@fda.hhs.gov.
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.
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 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.
- U.S. Monkeypox [mpox] 2022: Situation Summary (CDC)
- Fact sheet: Biden-Harris Administration’s Monkeypox [mpox] Outbreak Response (White House, June 28, 2022)
- JYNNEOS Monkeypox [mpox] Vaccine Distribution by Jurisdiction (HHS/ASPR)
- Information for health care professionals (CDC)
- Information for laboratory personnel (CDC)
- Information for veterinarians (CDC)
- Use of JYNNEOS (Smallpox and Monkeypox [mpox] Vaccine, Live, Nonreplicating) for Preexposure Vaccination of Persons at Risk for Occupational Exposure to Orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022 (CDC MMWR)
- Monkeypox [mpox] (WHO)
- What are Medical Countermeasures (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
- 1. 1Due to the conserved nature of VP37, tecovirimat resistance-associated substitutions in one orthopoxvirus are expected to apply to other orthopoxviruses.