Ebola
The European Medicines Agency (EMA) contributes to the global response to Ebola outbreaks by supporting the development and approval of vaccines and treatments for Ebola.
HumanRegulatory and procedural guidanceMedicines
The Ebola virus disease (formerly known as Ebola haemorrhagic fever) is a rare but severe, often fatal illness caused by the Ebola virus.
This virus is a member of the filovirus family.
Death rates in humans have varied from 25% to 90% in past outbreaks.
EMA supports the development and approval of vaccines and treatments for Ebola. It does so together with other regulators in the European Union (EU) and worldwide. This is in line with EMA's plan for managing emerging health threats.
For more information on Ebola virus disease, see the World Health Organization's (WHO) website.
To find out more about EMA's work on addressing public health threats, see:
EMA and other EU bodies are closely monitoring the ongoing Ebola disease outbreak caused by the Bundibugyo virus in the Democratic Republic of the Congo (DRC).
There are currently no authorised vaccines or treatments for Bundibugyo virus disease, unlike for the Ebola-Zaire strains.
EMA's Emergency Task Force (ETF) stands ready to support the development and regulatory evaluation of vaccines and therapeutics.
EMA is exchanging information with the European Centre for Disease Prevention and Control (ECDC), the European Commission, and the European medicines regulatory network.
The risk to people living in the EU / EEA is currently considered very low, based on an assessment published by the ECDC.
The WHO declared the outbreak caused by the Bundibugyo virus strain a public health emergency of international concern (PHEIC) on 17 May 2026.
For more information, see:
EMA works with WHO and regulatory authorities worldwide to advise on potential pathways for the development, evaluation and approval of Ebola medicines.
The Ebola vaccine Ervebo obtained a EU-wide conditional marketing authorisation in November 2019, following a positive recommendation from EMA. The EU granted this authorisation against the Ebola-Zaire strains.
EMA supported the development of this vaccine via the PRIME scheme.
Following Ervebo's EU approval, WHO has prequalified the vaccine, which means that it meets WHO's quality, safety and efficacy standards and is expected to speed up authorisation, access and roll-out in high-risk countries. Ervebo has been used in the DRC as part of WHO's 'ring vaccination programme'.
This vaccine is recommended by WHO's Strategic Advisory Group of Experts on Immunization (SAGE) for use in Ebola outbreaks.
Through close contact with developers of investigational treatments and with national regulators in the Member States, EMA has identified four treatments that could potentially be made available to patients, if required:
These medicines are being trialled in the DRC. In August 2019, the trial sponsor released important information on the progress of these trials and the implications for the medicines being tested.
EMA maintains close contact with developers of potential vaccines and treatments for Ebola, with a view to supporting the public health objectives of the EU and WHO.
EMA encourages developers of potential Ebola treatments and vaccines to use EMA's regulatory mechanisms to speed up development and approval, such as scientific advice, the accelerated assessment and conditional marketing authorisation procedures.
EMA has established an ad-hoc task force of European assessors with specialised knowledge in vaccines, infectious diseases and clinical trial design, to assist EMA's scientific committees in early scientific discussions and product assessments.
For more information, see:
The EU contributes to the global response to Ebola by providing expert and financial support to partners to deliver humanitarian support in affected areas and facilitate the development of vaccines and treatments for use in those areas.
The European Commission monitors events closely in cooperation with the European Centre for Disease Prevention and Control (ECDC) and WHO during an outbreak. ECDC produces a series of risk assessments, epidemiological updates and other information.
EMA supports the Commission in facilitating information exchange between EU Member States and coordinating approaches to preventing and preparing for potential Ebola outbreaks.
In 2014, the Innovative Medicines Initiative (IMI), a partnership between the EU and the European pharmaceutical industry, launched Ebola+. As part of this multi-million euro research programme on Ebola and related diseases, pharmaceutical companies, academics, regulators and others work together to tackle challenges in Ebola research.
For more information on the EU's response to Ebola and the current outbreak in the DRC, see:
Select the expandable panels below to find out about Ebola outbreaks from 2018-19 and 2014-16:
In 2018, the Democratic Republic of Congo (DRC) declared its ninth and tenth Ebola outbreaks.
The latest outbreak occurred 2019. It was the largest outbreak ever reported in the DRC and the second largest known outbreak in world history, after that affecting Guinea, Liberia and Sierra Leone in 2014 to 2016.
In July 2019, the WHO officially declared the latest outbreak in the DRC a public health emergency of international concern. WHO published a weekly situation report.
EMA activated level two of its plan for emerging health threats. The plan describes how EMA responds to and communicates on serious health threats.
According to the ECDC, there was a very low risk of spread to the EU via infected travellers.
For more information, see:
The 2014 outbreak of Ebola in West Africa was the largest and most complex Ebola outbreak in world history. It was unprecedented in terms of scale and geographical spread, mainly affecting the three West African countries of Guinea, Liberia and Sierra Leone.
The WHO declared the end of the outbreak in January 2016, with all known chains of transmission having stopped.
EMA established an ad-hoc group of European experts with specialised knowledge in vaccines, infectious diseases and clinical trial design to contribute to the global response.
EMA put in place an accelerated scientific advice procedure, which allowed developers of Ebola medicines and vaccines to request rapid advice for example on clinical trial design, manufacturing-related questions such as scaling-up production or batch release as well as post-authorisation safety monitoring of medicines.
EMA conducted a review of information on various experimental Ebola treatments under development during the outbreak, to provide an overview of the current state of knowledge to support decision-making by health authorities. EMA published an interim report and a final assessment report in February 2018.
For information about the timeline of the 2014-2016 Ebola outbreak, see below:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in May 2026.
18 May 2026