Towards a next generation influenza vaccine to protect citizens worldwide – an EU-India collaboration

Proposals should further the advancement of next generation influenza vaccine candidate(s) with improved efficacy and safety, duration of immunity, and reactivity against an increased breadth of influenza strains. Proposals should make use of new knowledge of, for example, structural biology, immunology, genetics and genomics, influenza transmission modelling, vaccine production, formulation and delivery methods.

Proposals should cover at least pre-clinical and/or early clinical research, selecting promising vaccine candidate(s), supporting their proof of concept, showcasing new pre-clinical or clinical knowledge.

The approach taken should include validation of one or more candidate vaccine(s) in a human challenge model[[Human Challenge Trials for Vaccine Development, World Health Organization: www.who.int/biologicals/expert_committee/Human_challenge_Trials_IK_final.pdf]] of influenza, and/or work to improve the influenza human challenge model itself. This latter work could include comparative testing of potential human challenge strains, and the responses they elicit in volunteers.

The suitability of the interventions to be developed should be addressed and assessed for different population groups, as should the suitability of the candidate(s) to low- or middle-income settings. The downstream constraints for the uptake of the intervention by national health systems should be taken into account.

Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least three participants from India. For more information, interested entities in India shall consult the website of the Department of Biotechnology (DBT) http://www.dbtindia.nic.in/funding-mechanism/call/# , where DBT will indicate the eligibility conditions to Indian applicants. Proposals should include participants from a variety of different disciplines.

The Commission considers that proposals requesting a contribution from the EU of between EUR 6 and 10 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Seasonal influenza is a major health burden, with an estimated 500,000 deaths around the world each year.[[World Health Organization seasonal influenza factsheet: http://www.who.int/mediacentre/factsheets/fs211/en/]] A further threat from influenza is the non-seasonal emergence of new strains, which have the potential to result in major influenza pandemics.

Despite the large danger posed by both seasonal and pandemic influenza, vaccines against flu are only moderately effective.[[ECDC, Influenza vaccination: https://ecdc.europa.eu/en/seasonal-influenza/prevention-and-control/influenza-vaccination]] In addition, current influenza vaccines need to be developed every year, as they only work against a narrow range of the hugely variable influenza subtypes, and are also highly vulnerable to strain mutations after an annual vaccine has been developed. Improved influenza vaccines would simultaneously ease a significant global health burden, and help the international community to better prepare in the event of an influenza pandemic.

The burden of seasonal influenza, and the ever-present threat of a new influenza pandemic, is a high priority for both Europe and India. In recent years, significant progress has been made by teams in India and Europe on influenza vaccination. To build on this shared recognition of the importance of influenza, as well as significant expertise available in both regions, a renewed effort by India and Europe towards the development of a next generation influenza vaccine is needed. Furthermore, utilisation of the human challenge model of influenza, or work to improve the model itself, may be an important step to progress this essential field.

• Further the development of a vaccine that could be effective against an increased breadth of seasonal strains and/or from the outset of a large-scale influenza pandemic.
• Utilisation of and/or further improvement of the human challenge model of influenza as a tool for candidate vaccine(s) assessment.
• Contribute to the reduction of the burden of influenza outbreaks worldwide, particularly in Europe and India. Contribute to the achievement of Sustainable Development Goal 3, to ensure health and well-being for all, at every stage of life.
• Specific to India, boost initiatives like the National Health Mission[[National Health Mission, Government of India: http://www.nhm.gov.in/nhm.html]] and Biopharma Mission [Innovate in India (I³)][[Innovate in India (i3), Government of India: http://www.dbtindia.nic.in/press-release-for-launch-of-national-biopharma-mission/]] of the Government of India by developing affordable biopharmaceuticals, including vaccines, for citizens the world over.