FDA Monkeypox Response
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:
- The FDA facilitates development and availability of medical products that can be used to diagnose, prevent, or treat monkeypox.
- 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.
What’s New
- 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.
- Monkeypox and Medical Devices
- Monkeypox Emergency Use Authorizations for Medical Devices, including new voluntary EUA templates for test developers
- Policy for Monkeypox Tests to Address the Public Health Emergency
- 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.
Fast Facts
Monkeypox is a rare disease that is caused by infection with monkeypox 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 Response for the latest response information
There is an approved vaccine and a cleared diagnostic test that can be used to help address the virus. For more information see: CDC Prevention Steps.
At this time, public health authorities have not recommended the general public needs to be vaccinated against monkeypox. Public health authorities have only recommended select individuals receive vaccination. For example, vaccination is recommended for those who have been exposed to monkeypox and for individuals with certain risk factors. Refer to the CDC’s recommendations, Considerations for Monkeypox Vaccination, for specific information.
Individuals who received a smallpox vaccine may have some protection against monkeypox. 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 monkeypox was first detected in the U.S., the FDA is working closely with the CDC, commercial laboratories, and traditional manufacturers to make monkeypox 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 monkeypox virus testing.
There are no FDA-approved treatments for monkeypox. 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 monkeypox. The safety and efficacy of TPOXX to treat monkeypox 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 monkeypox 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.
Monkeypox can spread to anyone through close, personal, often skin-to-skin contact, including:
- Direct contact with monkeypox rash, scabs, or body fluids from a person with monkeypox.
- Touching objects, fabrics (clothing, bedding, or towels), and surfaces that have been used by someone with monkeypox.
- Contact with respiratory secretions.
For more information, see: How it Spreads | Monkeypox | Poxvirus | CDC
A person with monkeypox 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 monkeypox remain isolated at home or at another location for the duration of illness.
Monkeypox can be spread by touching objects, fabrics (clothing or towels), and surfaces that have been used by someone with monkeypox.
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 | Poxvirus | CDC
Signs and Symptoms | Monkeypox | Poxvirus | CDC
Isolation and Prevention Practices for People with Monkeypox: CDC
Congregate Living Settings | Monkeypox | Poxvirus | CDC
Vaccines
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 Vaccine, Simplified Chinese, Korean, Tagalog, Vietnamese, Spanish
For more information: FDA Fast Facts: Jynneos, Korean, Simplified Chinese, Spanish, Tagalog, Vietnamese
Therapeutics
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.
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 monkeypox infection. Health care providers should encourage their patients with monkeypox 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 monkeypox.
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, monkeypox 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 monkeypox 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 monkeypox 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 monkeypox 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 |
A290V, L315M |
| 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 monkeypox 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 monkeypox 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.
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.
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 monkeypox disease in adults and pediatric patients (including neonates) with positive results of human monkeypox 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 monkeypox 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 ([email protected]) 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 [email protected] and call the CDER Emergency Coordinator at 301-796-9900.
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: [email protected].
Monkeypox and medical devices
For information on medical devices, including monkeypox tests, please see: Monkeypox and Medical Devices.
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.
Additional Resources
- U.S. Monkeypox 2022: Situation Summary (CDC)
- Fact sheet: Biden-Harris Administration’s Monkeypox Outbreak Response (White House, June 28, 2022)
- JYNNEOS Monkeypox 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 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 (WHO)
- What are Medical Countermeasures (FDA)
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: [email protected]
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.