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          Ebola Preparedness and Response Updates from FDAMCM Issues 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.


  Caption
        
      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 resources | Historical 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 approvalof 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 approvalof **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 approvalof **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

On October 10, 2019, 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.*Also see the FDA news release: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens*
	In 2017, FDA cleared a test that can be used in designated laboratories for the detection of Ebola.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

**December 21, 2020:**FDA Approves Treatment for Ebola Virus- 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. *Also see the label(PDF, 555 KB), and Drug Trials Snapshot (published January 13, 2021).*
	**October 14, 2020:**FDA Approves First Treatment for Ebola Virus- FDA approved 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. *Also see the label(PDF, 638 KB), Drug Trials Snapshot*,* and from HHS,**HHS Secretary Azar Statement on First FDA Approval of Ebola Therapeutic*
	**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*Additional updates (2018-2019)
	**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*
	**October 8, 2019:** EUA amendments - In response to CDC’s request, FDA concurred with modifications to the Healthcare Provider and Patient Fact Sheets for the CDC Ebola Virus NP Real-time RT-PCR Assay (PDF, 136 KB) and for theCDC Ebola Virus VP40 Real-time RT-PCR Assay (PDF,135 KB) to reflect changes to the CDC testing algorithm and updated epidemiological information concerning Ebola virus disease. *For more information including links to the revised fact sheets, see**Emergency Use Authorizations**(Devices)*
	**April 2, 2019:** EUA amendment - In response to Chembio Diagnostic Systems, Inc.'s request, FDA concurred (PDF, 88 KB) with the modifications to the authorizedInstructions for Use (PDF, 2 MB) for the DPP Ebola Antigen System to update 1) the cross-reactivity performance for *Plasmodium malariae*and *Streptococcus pneumoniae*in whole blood, and 2) the endogenous interference data for Rheumatoid Factor, Glucose, unconjugated bilirubin, cholesterol and HAMA. *For more information, see**Emergency Use Authorizations**(Devices)*
	**February 4, 2019:** New MCM regulatory science research profile: A new approach for understanding Ebola virus pathogenesis - In late 2018,  FDA awarded a contract to the Broad Institute to conduct the largest Ebola virus and host gene expression study to date. Researchers will use the latest sequencing technologies to assess how Ebola virus evolves and spreads within the body. This work will help fill significant gaps in the scientific community’s understanding of how Ebola virus disease progresses at the molecular level, which will help identify biological pathways and mechanisms that could be useful biomarkers to assess the efficacy of Ebola medical countermeasures, or advance development of potential therapeutics.
	**January 30, 2019 and February 1, 2019:** EUA amendments - In response to OraSure Technologies, Inc.’s request, FDA concurred with modifications to the Emergency Use Authorizations (EUAs) for the OraQuick Ebola Rapid Antigen Tests for use with whole blood and cadaveric oral fluid, respectively.  *For more information, see Emergency Use Authorizations (Devices)*
	**November 9, 2018:** FDA authorizes emergency use of first Ebola fingerstick test with portable reader- FDA issued an Emergency Use Authorization (EUA) for a rapid, single-use test for the detection of Ebola virus (*Zaire ebolavirus*). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. *Also see: Emergency Use Authorization*
	**September 14, 2018:**DoD and FDA collaborate to help speed potential countermeasures for Ebola and other viruses - new Medical Countermeasures Initiative Regulatory Science Program collaboration
	**August 13, 2018:**A Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks - FDA Center for Drug Evaluation and Research (CDER) statisticians and their collaborators at NIH and in West Africa faced the challenge of designing a trial to assess treatments for the deadly Ebola virus that could be conducted in a medical emergency. In their design, they used a Bayesian approach that include options for adaptations of the trial due to rapidly changing events on the ground and newly acquired information about the disease.
	**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.
	**May 30, 2018:**Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo*Additional historical Ebola response information from FDA*

Guidance for industry

January 2017: Guidance - Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus - notifies blood establishments that FDA has determined Ebola virus to be a transfusion-transmitted infection (TTI) and provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission is declared in at least one country. The guidance document applies to Ebola virus (species Zaire ebolavirus). The recommendations apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. (Federal Register notice)
	December 2015: FDA issued a final guidance, replacing the draft issued in June 2015 - Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings (Federal Register notice) *Read more about medical gowns**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

Ebola information from CDC (includes information on current outbreaks, symptoms, transmission, prevention, diagnosis, treatment, and preparedness)
	About Emergency Use Authorization
	Ebola virus disease, from the World Health Organization
	The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
	Information for Clinicians from CDC (includes information on U.S. healthcare settings, diagnosis/testing, and protecting healthcare workers)
	MCM-related cooperative arrangements, including Ebola-related agreements
	MCM regulatory science research, including Ebola-related projects
	Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks, from FDA CDERHistorical Ebola response information (West Africa Ebola epidemic 2014-2015)

Ebola Response Updates from FDA (ARCHIVED)
	2014-15 Ebola Outbreak - FDA Updates by Date (ARCHIVED)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 reportingPress: contact the Office of Media Affairs
Email fdaoma@fda.hhs.gov or call 301-796-4540Clinicians: Emergency Investigational New Drug (EIND) Applications for antiviral products
Instructions for physicians

                                                                                  Content current as of:
      05/03/2023
              
              
Topic(s)
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				    				       				    				       BiologicalHealth Topic(s)
			  Infectious Disease Treatment
			    			       			    			       EbolaMCM Issues

          
                        Advanced Manufacturing
          Antimicrobial Resistance Information from FDA
          Ebola Preparedness and Response Updates from FDA
          FDA/DoD Collaborations
          FDA Mpox Response
          Medical Countermeasure Monitoring and Assessment
          Pediatric Medical Countermeasures
          Preparedness Information for Consumers
          Radiological and Nuclear Emergency Preparedness Information from FDA
          Smallpox Preparedness and Response Updates from FDA
          Zika Virus Response Updates from FDA
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