EU Selects Vaccine Consortium with Danish Participation

Influenza remains one of the most significant global pandemic threats, and emerging virus variants continue to challenge existing vaccines. Through the EU4Health programme, the European Union is therefore investing in the development of next-generation influenza vaccines.

Statens Serum Institut is part of the NOFLU consortium, which is coordinated by NIVI Development and brings together seven partners across four EU countries. The consortium has been selected by the European Health and Digital Executive Agency (HaDEA) as one of three initiatives that will explore new vaccine technologies in parallel through early-stage clinical development.

At SSI, researchers will contribute expertise in immune responses to vaccination and experience from conducting clinical studies.

“It is essential that we test new vaccine approaches early and thoroughly if we are to be better prepared for future pandemics. At Statens Serum Institut, we have extensive experience in evaluating vaccine safety and effectiveness. We are bringing that expertise to this project as a consortium partner,” says Henrik Ullum, Chief Executive Officer of Statens Serum Institut.

A New Approach to Strengthening Immunity in the Airways

In the Phase 1 trial, the vaccine will be tested in humans for the first time. An mRNA-based vaccine candidate targeting H5N8 influenza will be evaluated for safety and immunogenicity in a study conducted at Gentofte Hospital.

Most existing influenza vaccines primarily induce systemic immunity. The NOFLU project is investigating a novel approach designed to stimulate mucosal immunity directly in the airways, where respiratory viruses such as influenza first establish infection.

If the results are promising, the project could form the basis for further clinical development and, ultimately, contribute to improved protection against future influenza pandemics.

FACTS

• The project is coordinated by NIVI Development, the clinical development unit within the Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI), a partnership between the University of Copenhagen and the Novo Nordisk Foundation. The consortium also includes Statens Serum Institut and Bavarian Nordic (Denmark), Ethris and Evonik (Germany), Ecraid (the Netherlands), and VisMederi (Italy).
  
  
• The NOFLU consortium will conduct a Phase 1 clinical trial of a novel mRNA-based influenza vaccine designed to stimulate immunity directly in the airways.
  
  
• The consortium was selected under the EU4Health programme following a competitive procedure managed by the European Health and Digital Executive Agency (HaDEA).
  
  
• The Phase 1 trial is funded with approximately EUR 13 million, with the possibility of additional funding in subsequent clinical phases.