Today (July 1), the European Commission adopted the decision granting marketing authorisations to the company Janssen, a Johnson & Johnson company, for a vaccine against Ebola. The authorisation was granted in one month, reducing the decision-making process timing in half, further demonstrating the Commission’s commitment in placing the protection of public health as a priority. The new Ebola vaccine, which consists of two components, called Zabdeno and Mvabea, had been in development with the support of the Commission. This decision follows a recommendation from the European Medicines Agency (EMA), which has assessed the benefits and risks of the vaccine.
As explained by EMA when it recommended the approval last February, the ability of the immune system to respond to the virus after vaccination with Zabdeno and Mvabea was studied in a total of 3,367 adults, adolescents and children who participated in five clinical studies conducted in Europe, Africa and the US.
The development of the vaccine is the result of rigorous work by several projects funded with just over €130 million through the Innovative Medicines Initiative (IMI), which is partly supported by the EU’s research and innovation programme, Horizon 2020. Following a comprehensive approach, the EBOVAC 1, 2 & 3, projects assessed the safety and tolerability of the Ebola vaccine regimen through clinical trials in Europe and Africa. The EBODAC project developed a communication strategy and tools to promote the acceptance and uptake of new Ebola vaccines. Finally, the EBOMAN project focused on accelerating the development and manufacture of the vaccine.
Source: The Commission
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