• 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.

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.

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 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

Isolation and Prevention Practices for People with Monkeypox [mpox]: CDC
Congregate Living Settings | Monkeypox [mpox] | Poxvirus | CDC

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

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.

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.