Ebola Preparedness and Response Updates from 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.
April 2, 2019: EUA amendment - In response to Chembio Diagnostic Systems, Inc.'s request, FDA concurred (PDF, 88 KB) with the modifications to the authorized Instructions 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 17, 2018: From the World Health Organization (WHO) - Notes for the record: Consultation on Monitored Emergency Use of Unregistered and Investigational Interventions for Ebola Virus Disease (EVD) (PDF, 118 KB) - Report from a group of independent scientific experts convened by the WHO for the purpose of evaluating investigational therapeutics for EVD during the current outbreak. The group was chaired by Dr. Edward Cox, Director of the Office of Antimicrobial Products, Center for Drug Evaluation and Research, FDA.
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 fromCDC).
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 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.
Currently, there are no FDA-approved vaccines to prevent Ebola.
- There are experimental Ebola vaccines under development; these investigational products have not yet been fully tested for safety or effectiveness.
Learn more about preventing Ebola from CDC.
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.
Currently, there are 11 Ebola diagnostic tests available for emergency use under FDA’s Emergency Use Authorization (EUA) authority (2 rapid antigen tests and 9 molecular tests). FDA has also cleared one test for the detection of Ebola that can be used in designated laboratories.
Learn more about Ebola diagnosis from CDC.
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
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.
- 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 CDER
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 email@example.com 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.