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Ebola Preparedness and Response Updates from FDA

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Created by Centers for Disease Control and Prevention (CDC) microbiologist, Cynthia Goldsmith, this digitally-colorized, transmission electron microscopic (TEM) image revealed some of the ultrastructural morphology displayed by an Ebola virus virion.
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Transmission electron micrograph of an Ebola virus virion (image: CDC/Cynthia Goldsmith)

What's new | Fast facts | FDA's role | Medical countermeasures | Guidance for industry | Consumer protection | Historical information | Additional resources | Contact FDA

FDA is working to help expedite the development and availability of medical products – such as treatments, vaccines, diagnostic tests, and personal protective equipment – with the potential to help bring Ebola outbreaks under control as quickly as possible. View the latest updates from FDA here.

What's new

  • December 19, 2019: First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response - FDA announced today the approval (PDF, 57 KB) of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD. Because of the public health importance of a vaccine to prevent EVD, the FDA worked closely with the company and completed its evaluation of the safety and effectiveness of Ervebo in less than six months. Also see: ERVEBO

  • November 14, 2019: FDA awarded a contract in September 2019 to the University of California, Los Angeles (UCLA) School of Public Health, who—in collaboration with the Congolese Institut National de la Recherche Biomédicale (National Institute for Biomedical Research) (INRB)—will expand a biobank of plasma and peripheral blood mononuclear cell (PBMC) samples to help support the development of medical countermeasures against Ebola and Marburg viruses. More FDA Ebola research

  • November 12, 2019: EUA amendment - In response to BioFire Defense LLC’s request, FDA concurred (PDF, 151 KB) with modifications to the authorized Instructions for Use of the FilmArray Biothreat-E test to include new data on analytical exclusivity wet-testing and associated limitations. FDA also concurred with the modifications to the (1) Instructions for Use, including wording in the intended use, to improve the overall clarity and accuracy of the document, and (2) Healthcare Provider and Patient Fact Sheets, that were requested by FDA. For more information, including links to the revised documents, see Emergency Use Authorizations (Devices)

  • November 6, 2019: In addition to supporting ongoing response to Ebola outbreaks in the Democratic Republic of the Congo (DRC), FDA and government partners are conducting studies in West Africa to better understand how Ebola affects patients who have survived, and to learn how to more effectively treat these patients’ chronic health problems. In 2016, FDA awarded a contract to Stanford University to help the global scientific community better understand the course of Ebola virus infection—an important factor in finding new treatments. In September 2019, the project was expanded to apply a new method to the study of Ebola and Zika tissue samples. More FDA Ebola research

  • October 10, 2019: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens - FDA allowed marketing (PDF, 255 KB) of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for Ebola virus disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed. Previously, the test had been authorized only for emergency use under FDA’s EUA authority. With granting of the De Novo request for this test, FDA revoked two EUAs for this test: 1) an EUA for the OraQuick Ebola Rapid Antigen Test for use with whole blood specimens initially issued on July 31, 2015, and 2) the OraQuick Ebola Rapid Antigen Test for use with cadaveric oral fluid initially issued on March 4, 2016. For more information, see Emergency Use Authorization--Archived Information

 

Fast facts

  • Ebola prevention poster (Photo by Kristian Roth, PhD, FDA, taken in Liberia, August 2015)Ebola is the cause of a viral hemorrhagic fever disease (Ebola virus disease, or EVD).

  • Currently, there are no FDA-approved vaccines or drugs to prevent or treat Ebola.

  • Ebola does not pose a significant risk to the U.S. public. The viruses that cause EVD are located mainly in sub-Saharan Africa.

  • Transmission: People can get EVD through direct contact with an infected animal (bat or nonhuman primate) or a sick or dead person infected with Ebola virus. (More, from CDC)

  • Prevention: When living in or traveling to a region where Ebola virus is widespread, learn how to protect yourself and prevent the spread of EVD (info from CDC).

    • Vaccine: On December 19, 2019, FDA announced the approval of Ervebo, the first FDA-approved vaccine for the prevention of EVD, caused by Zaire ebolavirus in individuals 18 years of age and older.

  • Treatment: CDC recommends supportive therapy for patients as the primary treatment for Ebola. This includes balancing the patient’s fluids and electrolytes, maintaining their oxygen status and blood pressure and treating them for any complicating infections.

  • Also see from CDC: 2018 Democratic Republic of the Congo, Bikoro Ebola outbreak, May 2018

Image: Ebola prevention poster. (Photo by Kristian Roth, PhD, FDA, taken in Liberia, August 2015)

FDA's role

FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats.

FDA’s roles in Ebola preparedness and response include:

  • Facilitating the development and availability of medical countermeasures (MCMs) that can be used to diagnose, prevent, or treat Ebola virus disease. Also see Medical countermeasures and Guidance for industry below, and What are medical countermeasures?

  • Working with medical product sponsors to clarify regulatory and data requirements necessary to rapidly advance development of products essential to supporting response efforts.

  • Protecting the safety of the nation’s blood supply and human cells, tissues, and cellular/tissue-based products for transplantation. Also see Guidance for industry below.

  • Enabling access to investigational MCMs—when necessary—through an appropriate mechanism such as under an Emergency Use Authorization (EUA) or under expanded access mechanisms when the clinical circumstances warrant.

  • Protecting consumers against fraudulent products - 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 Ebola virus and other conditions and takes appropriate action to protect consumers. Also see Consumer protection below.  

Medical countermeasures

Vaccines

On December 19, 2019, FDA announced the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Also see: ERVEBO

Learn more about preventing Ebola from CDC.

Therapeutics

Currently, there are no FDA-approved drugs to prevent or treat Ebola.

  • There are experimental Ebola treatments under development; these investigational products have not yet been fully tested for safety or effectiveness.

Learn more about Ebola treatment from CDC.

Diagnostics

Cleared diagnostics

Diagnostic EUAs

Currently, there are 10 Ebola diagnostic tests available for emergency use under FDA’s Emergency Use Authorization (EUA) authority (1 rapid antigen test and 9 molecular tests).

View current Ebola diagnostic EUAs

Learn more about Ebola diagnosis from CDC. 

Guidance for industry

More: Guidance and Other Information of Special Interest to MCM Stakeholders

Consumer protection

Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear. The FDA monitors for fraudulent products and false product claims related to the Ebola virus and takes appropriate action to protect consumers.

  • There are no approved treatments for Ebola available for purchase on the Internet.

  • Experimental Ebola vaccines and treatments are still in development, and have not yet been fully tested for safety or effectiveness. A claim that a product prevents, treats, or cures a disease requires prior approval by FDA.

  • Consumers are warned to beware unapproved products sold online and in retail stores claiming to prevent or treat the Ebola virus and other conditions, such as cancer, autism, Parkinson’s and heart disease. Consumers who have seen these fraudulent products or false claims are encouraged to report them to the FDA.

Fraudulent product updates and warning letters:

  • June 6, 2018: FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens - FDA filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean, the company’s president and chief executive officer, to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus (MRSA), and Ebola. Claims that a hand sanitizer can protect consumers against infection from pathogens are drug claims and therefore, these products are regulated by the FDA as drugs. These products from Innovative BioDefense, Inc. have not been proven to be safe and effective for these uses and are not approved by the FDA.

Historical Ebola response information (West Africa Ebola epidemic 2014-2015)

Additional resources

Contact FDA

Consumers and general information: contact FDA
You may also call 1-888-INFO-FDA / (1-888-463-6332)

Report a fraudulent Ebola product
Includes options for phone and online reporting

Press: contact the Office of Media Affairs
Email fdaoma@fda.hhs.gov or call 301-796-4540

Clinicians: Emergency Investigational New Drug (EIND) Applications for antiviral products
Instructions for physicians. You may also call 301-796-1500 regarding EINDs.

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