Influenza remains one of the most persistent pandemic threats, with new variants continuing to emerge and challenge existing prevention strategies. Strengthening preparedness therefore requires both innovative new vaccine technologies and the ability to evaluate promising vaccine approaches rigorously and early in clinical development.
As a result of a competitive procedure managed by the European Health and Digital Executive Agency (HaDEA) and funded through the EU4Health programme, NOFLU is one of just three contract awardees selected as part of a broader EU initiative to explore multiple vaccine strategies in parallel. Coordinated by NIVI Development, the vaccine development arm of NIVI, the consortium comprises seven partners from four EU countries.
The programme will generate early clinical evidence on feasibility, safety and immune response for a vaccine concept designed to induce mucosal immunity in the airways, the primary entry point for respiratory infections like influenza. If the clinical results are favourable and the project progresses through subsequent clinical phases, it could ultimately lead to the development of a new vaccine to help protect against future influenza pandemics.
“We are delighted to contribute to the EU’s efforts to strengthen influenza pandemic preparedness through an innovative Phase 1 programme,” says Else Marie Agger, CEO of NIVI Development. “The selection of the consortium reflects confidence in our innovative approach to induce an immune response in the airways combined with an ambitious early-stage clinical development plan.”
Clinical evaluation of a mucosal vaccine strategy
Respiratory viruses establish infection in the airways, yet almost all existing vaccines primarily induce systemic immune responses. The NOFLU novel vaccine concept is designed to stimulate mucosal immunity at the site of entry, in the respiratory tract. Strengthening mucosal immune protection is a central scientific priority of NIVI and could help limit infection and transmission of airborne pandemics.
The Phase 1 programme will evaluate an mRNA-based vaccine candidate targeting H5N8 influenza, a virus subtype with known pandemic potential. The clinical study will assess safety, feasibility and immunological responses, including a comparative evaluation of intramuscular and intranasal administration routes, and will be conducted at Gentofte Hospital in Copenhagen.
Building on complementary consortium expertise, including Statens Serum Institut (SSI), and mRNA technology from Ethris, the programme aims to translate a novel mucosal vaccine concept into early-stage clinical evaluation.
Carsten Rudolph, Ph.D., Founder and Chief Executive Officer of Ethris, added “The mRNA vaccine we are evaluating as part of the NOFLU consortium is a new approach. It is designed to trigger a robust immune response at the site of influenza entry and uses a stabilized, non-immunogenic RNA formulation to ensure safety and optimize performance. Building on previous clinical proof-of-concept, we are excited about its potential to generate local immunity and reduce transmission, which could have meaningful implications for containing influenza pandemics.”
The programme is part of a broader EU initiative to explore multiple vaccine strategies in parallel through early-stage clinical evaluation. The current contract covers Phase 1 only, with progression to later phases subject to further review and evaluation within the EU framework. With approximately EUR 13 million awarded for Phase 1, the programme could potentially secure up to EUR 35 million for Phase 2 and EUR 100 million for Phase 3 – in total up to EUR 148 million.
About the NOFLU consortium
The NOFLU consortium is established as a response to the HaDEA tender for development of next generation vaccines against influenza. The partners have a bold ambition to advance clinical implementation in an integrated setup, reflecting a shared commitment to scientific rigour, operational excellence, and public health impact of a novel vaccine concept.
The collaboration brings together complementary expertise spanning mRNA platform, formulation and delivery, preclinical research, clinical trial execution, and immunological assessment.
The consortium comprises seven organisations: NIVI Development, Statens Serum Institut, and Bavarian Nordic (Denmark); Ethris and Evonik (Germany); Ecraid (the Netherlands); and VisMederi (Italy).
