Vaccine against Ebola: Commission grants new market authorisations
The European Commission yesterday 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.
Stella Kyriakides, Commissioner in charge of Health and Food Safety, yesterday said:
“This is the second Ebola vaccine that the Commission authorises in less than a year and confirms once again that the EU remains at the forefront of the global effort to save lives from this virus. We know very well from the coronavirus crisis that viruses do not respect borders – protecting the health of others protects the health of all.”
Mariya Gabriel, Commissioner in charge of Research, yesterday said:
“Today, we can be glad to have supported the development of the Ebola vaccine with EU funding, in partnership with the European pharmaceutical sector under the Innovative Medicines Initiative. The investment from the EU's research programme Horizon 2020 into several Innovative Medicines Initiative Ebola projects is now bearing fruit. This demonstrates, yet again, the power of collaboration and European R&I leadership to tackle global health threats.“
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.
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