Longer description of your proposed project

Pandemic Influenza A remains an ongoing threat to human health. Currently, there is no proactive generation of pre-immunity to pandemic influenza strains. This proposal aims to increase resilience against pandemic influenza through increasing pre-immunity. Initially, this was via inclusion of a pandemic influenza strain in the seasonal quadrivalent influenza vaccine recommended by WHO. Now pivoting to address this problem through a universal priming vaccine against all influenza subtypes.

Seasonal influenza strains currently are either trivalent or quadrivalent vaccines that include 3 or 4 strains of Influenza A or B (2 strains of Influenza A and 1 or 2 strains of Influenza B). Since 2020, most likely due to indirect effects on human transmission caused by non-pharmacological interventions to counter the COVID-19 epidemic, it appears that only one strain of Influenza B now circulates. The current WHO response to this fortunate occurrence is to recommend manufacturing trivalent seasonal influenza vaccines in future. My alternative suggestion was to take advantage of the vacant quadrivalent strain slot to add in an additional pandemic strain of Influenza A. This would improve population pre-immunity against potential future Influenza A pandemics.

I used this funding to attend academic and medical conferences and WHO activities in Australia and overseas. This grant funded a collaboration with a University of Melbourne academic group to generate modelling data that showed pre-immunity would reduce deaths in a future pandemic. This modelling was presented as posters at the "OPTIONS for the control of Influenza XII" conference, and academic journal manuscripts are expected.

Stakeholder feedback on the inclusion of a pandemic influenza strain in a quadrivalent vaccine was negative. The potential harm of this change in increasing vaccine hesitancy and decreasing vaccine uptake, the difficulty of selecting a pre-pandemic influenza strain, and the uncertain amount of protective benefit from the vaccine means that e.g. the FDA would be unlikely to approve this product.

However, pre-immunity through improved influenza vaccines providing Pandemic Prevention on Day 1 is an area of interest to BARDA, and funding proposals for work in this area are currently being advertised (see supporting document link). I am pivoting to explore this area and encourage development of these products.

I can't see a way that I will financially benefit if this proposal is taken up, and I do not work for a company that produces vaccines.

Describe why you think you're qualified to work on this

I have a PhD in Biochemistry and have worked in the pharmaceutical industry for 25 years in various regulatory affairs and product commercialisation roles. I have a good understanding of the influenza vaccine strain selection process, however my in-person experience is of the Australia process only.

From my roles, I know how to talk to and convince medical specialists, pharmaceutical regulators, and academic researchers.

Other ways I can learn about you

LinkedIn profile: www.linkedin.com/in/duncanpurvisau

How much money do you need?

USD $30,000 (granted as ACX grant).

Links to any supporting documents or information

https://cdn.who.int/media/docs/default-source/influenza/who-influenza-recommendations/vcm-southern-hemisphere-recommendation-2024/202309_recommendation.pdf includes information on lack of circulating Influenza B (Yamagata-like) strains since March 2020, and recommends deletion of this strain from future vaccines.

Microsoft Word - BAA DRIVe Special Instructions_4.9.19_Final - CLEAN.docx (hhs.gov)

US agency document setting out areas for future influenza vaccine innovation, specifically Pandemic Protection on Day 1.

Estimate your probability of succeeding if you get the amount of money you asked for

I think it is more likely than not that one or more academic publication results from this idea. I think it is 20-50% that this idea is seriously considered as part of future WHO deliberations on the seasonal influenza vaccine composition. I think it is <20% that WHO changes their recommendation, but I'm hoping to at least shift the Overton window of their discussions and deliberations, so inclusion of a pandemic influenza strain is debated as a serious option.

From not being discussed at all as part of Australian Influenza Vaccine Committee discussions in 2023, the issue of transitioning to trivalent influenza vaccines was an agenda topic in 2024, and discussion of the need to maintain quadrivalent influenza licences, and what types of fourth influenza strain might need to be included in future, was openly discussed (including the idea of a pre-pandemic strain). I consider the Overton window to have shifted.