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

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FDA’s Role | What’s New | Fast Facts | Vaccines | Therapeutics |  Diagnostics |  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

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Fast Facts

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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

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

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Therapeutics  

Currently, there is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access, or “compassionate use.”

As background, in 2018, the FDA approved TPOXX for treatment of smallpox in adults and children. Because smallpox has been eradicated globally, TPOXX was approved under the FDA’s “Animal Rule” regulations, as it was neither ethical nor feasible to test the efficacy of the drug in humans. TPOXX was approved for treatment of smallpox 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 without a smallpox or monkeypox infection.

Unlike smallpox, monkeypox was endemic in other parts of the world (e.g., the Democratic Republic of the Congo) at the time of TPOXX’s initial approval. Consequently, it remained both ethical and feasible to conduct clinical trials in humans to study TPOXX for the treatment of monkeypox disease. Therefore, TPOXX for the treatment of monkeypox disease was not eligible for approval under the pathway described in the FDA’s Animal Rule regulations. 

The CDC holds an Expanded Access Investigational New Drug protocol (EA-IND) that allows for the use of TPOXX for treatment of orthopoxvirus infections other than variola (which is the virus that causes smallpox), including monkeypox, in adults and children of all ages. The EA-IND provides an umbrella regulatory coverage, so clinicians and facilities do not need to request and obtain their own INDs. The FDA worked closely with the CDC to streamline the protocol to reduce data collection and reporting requirements. The revised protocol is now available for use.

Importantly, safety and efficacy of TPOXX to treat monkeypox in humans has not been established. Conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential. We don’t currently know if TPOXX will be beneficial, harmful, or have no effect in treating patients with monkeypox, since drugs that are effective in animal studies are not always effective in humans. 

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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Diagnostics

Laboratory diagnostic testing for monkeypox virus is available in designated CDC Laboratory Response Network (LRN) and other CDC-designated laboratories using the CDC’s FDA-cleared orthopoxvirus tests. 

In June 2022, the HHS, through the CDC, began shipping FDA-cleared orthopoxvirus tests to five commercial laboratory companies to quickly increase monkeypox testing capacity and access. 

In addition to clearing the CDC's test for distribution beyond the LRN, the FDA also cleared the use of additional reagents and automation to increase testing capacity of laboratories using the CDC test. And the CDC published testing protocol from its FDA-cleared orthopoxvirus test for qualified laboratories to use to begin testing for monkeypox. 

Cleared orthopoxvirus diagnostic tests

The CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set was first cleared in 2018 for in vitro qualitative presumptive detection of non-variola orthopoxvirus DNA extracted from human pustular or vesicular rash specimens and viral cell culture lysates submitted to a LRN reference laboratory. Additional 510(k)s were cleared on June 10, 2022 (K221658), to clear the use of additional reagents and automation, and June 24, 2022 (K221834), to clear the test for use in CDC-designated laboratories outside the LRN. 

Laboratory Developed Tests 

There may also be laboratory developed tests (LDTs) available for orthopoxvirus or specifically for monkeypox. LDTs are tests designed, manufactured, and used within a single CLIA-certified laboratory that meets the requirement for high complexity testing. 

The FDA generally exercises enforcement discretion with respect to LDTs, including those developed by hospitals or academic laboratories, meaning the FDA generally does not exercise its authority to enforce the regulatory requirements for these devices, although it maintains that authority. 

The general enforcement discretion approach for LDTs is not appropriate in all circumstances, for example, for tests used for declared emergencies under the Federal Food, Drug, and Cosmetic Act. In the case of an emergency involving an outbreak, inaccurate tests can lead to greater spread of the disease and poor management of the outbreak due to false results. The FDA, therefore, generally has expected Emergency Use Authorizations for LDTs during all prior declared emergencies, starting with H1N1 in 2009 and continuing through the COVID-19 emergency. 

The FDA is monitoring the situation with respect to considering appropriate policies, including enforcement discretion policies, for LDTs and other tests for monkeypox, taking into account lessons learned from COVID-19.

Information for test developers

The FDA is actively working with private and public entities to help ensure any potential increased demand for these tests will be met and is open to working with any additional interested entities. The FDA may issue guidance to provide helpful recommendations to test developers.

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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

 

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