The March 2014 outbreak of Ebola virus disease in West Africa was the largest and most complex Ebola outbreak to date. It was unprecedented in terms of scale and geographical spread of the disease. The European Medicines Agency (EMA) contributed to the global response against the Ebola outbreak.
The Ebola outbreak affected the three West African countries of Guinea, Liberia and Sierra Leone the most and lasted several months. On 4 January 2016, the World Health Organization (WHO) declared the end of the outbreak in the last of the countries affected, Liberia, with all known chains of transmission stopped in West Africa.
There are no approved medicines to protect people from Ebola or to treat the disease, however, medicines against this disease are under development. Some experimental treatments against Ebola have reportedly shown encouraging results in the laboratory or in animals, but they have not yet been fully studied in people.
Role of EMA
The Agency has been working together with regulatory authorities around the world to support WHO and to advise on possible pathways for the development, evaluation and approval of vaccines and medicines to fight Ebola.
In Europe, the Agency supports the work of the European Commission to facilitate information exchange between European Union (EU) Member States and to coordinate approaches on prevention of and preparation for Ebola outbreaks.
The Agency 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 against Ebola.
Facilitating development of Ebola medicines
EMA has been in close contact with developers of treatments and vaccines against Ebola, to encourage the development of medicines and vaccines through existing regulatory mechanisms such as scientific advice or orphan designation.
The Agency put in place an accelerated scientific advice procedure for developers of Ebola medicines and vaccines. Through rapid scientific advice, developers were able to request 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. As the epidemic is now under control, the scientific advice procedure follows the regular timetable.
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Orphan designation provides incentives to developers to stimulate development and facilitate placing on the market of medicines for diseases that occur in less than 5 in 10,000 people in the EU.
EMA has been collaborating very closely with the United States Food and Drug Administration (FDA) on orphan medicines for many years. The Agencies exchange information on the applications received and their assessment, to facilitate understanding of data requirements for the relevant applications. Developers of Ebola medicines were encouraged to submit applications for orphan designation to EMA and FDA in parallel, to help speed up the development process for these medicines globally.
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Rolling review of data
During the Ebola crisis, the Agency established a type of rolling review to allow experts to continuously assess the data on new medicines as they became available. Through this process, the Agency was able to develop increasingly robust scientific opinions based on additional data provided during the assessment process.
The initial review and subsequent updates were shared with healthcare decision-makers in concerned countries. This enabled them to take informed decisions on whether and how they wanted to use vaccines and medicines during the latest outbreak, taking into account their specific situation.
Reviewing information on Ebola experimental treatments
In September 2014, EMA started to review available information on the various experimental Ebola treatments under development. The goal was to provide an overview of the current state of knowledge to support decision-making by health authorities.
In February 2016, EMA published an assessment report on experimental medicines for treating patients infected with Ebola. An interim report was published in November 2014 while the outbreak was ongoing:
- Final assessment report on medicinal products under development for the treatment of Ebola
- Interim assessment report on medicinal products under development for the treatment of Ebola
Initiatives in the EU
During the Ebola outbreak, the European Commission's Health & Consumers Directorate-General monitored events closely in cooperation with the European Centre for Disease Prevention and Control (ECDC) and the WHO during the outbreak. ECDC produced a series of risk assessments, epidemiological updates and other information.
On 6 November 2014, the Innovative Medicines Initiative (IMI), a partnership between the European Union and the European pharmaceutical industry, launched Ebola+. As part of this multi-million euro research programme on Ebola and related diseases such as Marburg haemorrhagic fever, pharmaceutical companies collaborate with each other as well as experts from universities, regulators and others to tackle challenges in Ebola research.
- Experimental Ebola treatments still at early stage of development (16/12/2014)
- EMA advises on development plan for GSK Ebola vaccine (29/10/2014)
- EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available (22/10/2014)
- Speeding up development of Ebola treatments and vaccines (20/10/2014)
- Ebola outbreak: EMA to review experimental medicines to support treatment decisions (26/09/2014)
- Medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks (04/09/2014)