EBOMAN

Manufacturing and development for rapid access Ebola vaccine

FACTS & FIGURES

Start Date
End Date
Call
IMI2 - Call 2
Grant agreement number
115850

Contributions
IMI Funding
1 023 325
EFPIA in kind
35 989 493
Other
3 175 411
Total Cost40 188 229

Summary

The focus of the EBOMAN project is on accelerating the development and manufacturing of a ‘prime-boost’ Ebola vaccine regimen. In the short term, this will ensure the delivery of sufficient quantities of the vaccine regimen to support the two EBOVAC projects to perform the clinical trials. In parallel, this project will create additional vaccine production capacity to allow for the rapid preparation of large quantities of vaccines.

Vaccine manufacture capability

Ebola vaccines can only be manufactured in facilities with an appropriate biosafety rating. Relatively few manufacturers have the biosafety rating required for the manufacture of Ebola vaccines, and this is slowing down the production of vaccine candidates.

The focus of the EBOMAN project is on accelerating the development and manufacturing of a ‘prime-boost’ Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. In the short term, this will ensure the delivery of sufficient quantities of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen to support the two EBOVAC projects to perform the clinical trials. In parallel, this project will create additional vaccine production capacity to allow for the rapid preparation of large quantities of vaccines.

A part of the Ebola+ Programme

The IMI Ebola+ programme was launched in response to the Ebola virus disease (EVD) outbreak that started in western Africa in 2014. The comprehensive programme contributes to efforts to tackle a wide range of challenges in Ebola research, including vaccines development, clinical trials, and transport, as well as diagnostics. The programme complements work being carried out with the support of other funding bodies. In addition to Ebola, the programme will also address related diseases, such as Marburg.

About Ebola and related diseases

Ebola virus disease (EVD), previously known as Ebola haemorrhagic fever, is a rare and deadly disease caused by infection with one of the Ebola virus strains. The virus spreads in the human population through direct human-to-human contact with the bodily fluids of infected patients who are showing symptoms. It has an incubation period of 2-21 days, and it usually begins with flu-like symptoms, but rapidly progresses to multiple organ failure and blood-clotting abnormalities which manifest as internal and external haemorrhages (bleeding). It is fatal in between 25% and 90% of cases. There is currently no licensed treatment against EVD, and the development of treatments and preventive measures such as vaccines is hampered by challenges including manufacturing-related hurdles, the stability of vaccines during transport and storage, vaccine deployment, and the time taken to diagnose cases of EVD.

Ebola is a member of the filovirus family of viruses, which also includes Marburg virus. Like Ebola, Marburg causes cause severe, often fatal haemorrhagic fever in humans and other primates (monkeys, gorillas and chimpanzees), and like Ebola, it is transmitted directly from one person to another. (In contrast, other viruses that cause haemorrhagic fevers are spread via intermediate hosts - for example, dengue fever is transmitted by mosquitoes.) There is no specific treatment or vaccine against Marburg haemorrhagic fever.

The 2014-15 Ebola epidemic was unprecedented in its scale and geographical distribution. By the middle of 2015, World Health Organization (WHO) statistics recorded over 27 000 cases and 11 000 deaths from the disease, most of them in Guinea, Liberia, and Sierra Leone. The epidemic highlighted the need for research into better vaccines, diagnostics and treatments to stop future epidemics in their tracks.

Achievements & News

"This was a highly valuable experience for us" – meet the SME in IMI’s EBOMAN project
May 2017

Vibalogics, a small-to-medium sized enterprise (SME) from Germany, is the managing entity of IMI’s EBOMAN project. Although the company had no prior experience with IMI or Horizon 2020 (H2020) projects, they prepared their submission for EBOMAN in only four weeks and won the grant.### Two years later, they achieved a big milestone: the building of a new, state-of-the art filling line to speed up the production of live vaccines for clinical trials.The IMI programme office interviewed Stefan Beyer, managing director of Vibalogics, about his company's experiences of setting up and running an IMI project. "This was a highly valuable experience for us’, he said . ‘Firstly, we have been very proud to have been selected for this grant – this honours all the work we have done in the past to establish our company in this niche. Participating in IMI triggered and accelerated the expansion of our business and it brought us more customers. It also helped us to establish new partnerships and increased our visibility on a global level. All taken together, it has been very beneficial for us."

Participants Show participants on map

EFPIA companies
  • Janssen Vaccines & Prevention B.V, Leiden, Netherlands
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Vibalogics GmbH, Cuxhaven, Germany
Non EFPIA companies
  • Bavarian Nordic, Kvistgaard, Denmark

CONTACT

Project coordinator
Olaf Stuhldreier
Vibalogics GmbH
++49 4721 565-570
Olaf.Stuhldreier[at]vibalogics.com
EFPIA lead
Tjeerdsma, Peter
Janssen Vaccines & Prevention B.V
Leiden, Netherlands
PTjeerds[at]its.jnj.com