Brussels — Today, 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.
Stella Kyriakides, Commissioner in charge of Health and Food Safety, 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, 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.
The authorisation of a medicine under the centralised procedure is a two-stage process, involving the European Medicines Agency (EMA) and the Commission. EMA assesses the benefits and risks of medicines and makes recommendations to the Commission, which then takes a final legally binding decision on whether or not the medicine can be marketed in the EU.
This decision is issued normally within the legal deadline of 67 days of the scientific opinion of EMA (for Zabdeno and Mvabea the date was 28 May). This phase includes, among other things, the translation of the product guidelines in all EU languages and a consultation with Member States. In view of the public health interest, the Commission has accelerated this process and authorised the medicine in around a month, in other words reducing the time taken for the decision-making process in half.
The assessment report for the vaccines will be published on EMA's website.
IMI funds large-scale collaborative research projects bringing together academic and industrial partners, as well as patients and other stakeholders.
In November 2014, IMI responded very rapidly to the West Africa outbreak of Ebola by allocating €280 million to a comprehensive call for proposals to tackle a wide range of challenges in Ebola research, including vaccines development, clinical trials, storage and transport, as well as diagnostics. The first projects under the IMI Ebola+ programme started as early as January 2015 and several focused on the development of the Janssen vaccine regimen. Since 2014, IMI has funded 12 projects on Ebola and related diseases with a total combined budget of over EUR 300 million.
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SOURCE European Commission