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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)

Fast facts | FDA's role | Medical countermeasures | Updates from FDA | Guidance for industry | Consumer protection | Additional resourcesHistorical information | 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.

Fast facts

  • Ebola prevention poster (Photo by Kristian Roth, PhD, FDA, taken in Liberia, August 2015)Ebola Virus Disease (EVD) is a rare and deadly disease in people and nonhuman primates.

  • Ebola does not pose a significant risk to the U.S. public. The viruses that cause EVD are located mainly in sub-Saharan Africa. Ebola is caused by an infection with a group of viruses within the genus Ebolavirus. (Also see Note on terminology below)

  • 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. (Also see Vaccines below)

  • Treatment: There are currently two treatments approved by FDA to treat EVD caused by Zaire ebolavirus in adults and children. (Also see Therapeutics below)

  • Also see from CDC: Current and Recent Outbreaks

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

A note on terminology: Sudan virus (Sudan ebolavirus) is one of six members of the genus Ebolavirus (genus name is a shortened version of the term Ebola-like viruses). The term Ebola virus was for years used to describe a collection of filoviruses that produce a common disease state referred-to as Ebola Virus Disease (EVD). Updates to the taxonomy of these viruses led to the establishment of the genus Ebolavirus with six distinct viruses currently as member species. The term Ebola virus more precisely refers to one member of this genus: Zaire ebolavirus. EVD now refers to the disease state caused by Zaire ebolavirus. Sudan virus is no longer referred to as Ebola Sudan. The disease state caused by Sudan ebolavirus is now referred to specifically as Sudan Virus Disease (SVD).    

Medical countermeasures approved or authorized for EVD caused by Zaire ebolavirus cannot be directly applied to Sudan ebolavirus outbreaks, or outbreaks caused by other Ebolaviruses, because these viruses are different species that cannot be assumed to respond in the same way to the same 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

On December 21, 2020, FDA approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebola virus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell.The most common symptoms experienced while receiving Ebanga include: fever, tachycardia (fast heart rate), diarrhea, vomiting, hypotension (low blood pressure), tachypnea (fast breathing) and chills; however, these are also common symptoms of Ebolavirus infection. Hypersensitivity, including infusion-related events, can occur in patients taking Ebanga, and treatment should be discontinued in the event of a hypersensitivity reaction.Patients who receive Ebanga should avoid the concurrent administration of a live virus vaccine against Ebolavirus. There is the potential for Ebanga to inhibit replication of a live vaccine virus and possibly reduce the efficacy of this vaccine. For more information, see the label (PDF, 555 KB), and Drug Trials Snapshot: EBANGA.

On October 14, 2020, FDA announced the approval of Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. The most common symptoms experienced while receiving Inmazeb included: fever, chills, tachycardia (fast heart rate), tachypnea (fast breathing), and vomiting; however, these are also common symptoms of Ebola virus infection. Patients who receive Inmazeb should avoid the concurrent administration of a live vaccine due to the treatment’s potential to inhibit replication of a live vaccine virus indicated for prevention of Ebola virus infection and possibly reduce the vaccine’s efficacy. Hypersensitivity, including infusion-related events, can occur in patients taking Inmazeb, and treatment should be discontinued in the event of a hypersensitivity reaction. For more information, see the label (PDF, 638 KB) and Drug Trials Snapshots: INMAZEB.

Learn more about Ebola treatment from CDC, including information for clinicians.

Diagnostics

Cleared diagnostics

Diagnostic EUAs

Several Ebola diagnostic tests have been available for emergency use under FDA’s Emergency Use Authorization (EUA) authority to detect Zaire ebolavirus since 2014. 

View current Ebola diagnostic EUAs

Learn more about Ebola diagnosis from CDC. 

Updates from FDA

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.

  • 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.

Additional resources

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

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

 

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