Evaluation will be informed by the Desired Product Attributes, which describe product requirements and target nonclinical metrics aligned with approved two-dose pandemic influenza vaccines.
Evaluation criteria
Product requirements
Submissions from eligible entrants that meet the following product specifications will be considered for evaluation.
The proposed vaccine candidate:
- Must be either an inactivated virus vaccine, or a recombinant hemagglutinin (rHA) protein vaccine. Entrants need not have access to an existing approved influenza product themselves; they need only submit a candidate built on one of these two in-scope platforms.
- Must only be administered by the following methods: intramuscular, intradermal, transdermal, subcutaneous.
- Must be targeted toward pandemic influenza A(H5N1). The vaccine candidate may target other influenza A subtypes (e.g., influenza A(H3N2)) concurrently, as long as pandemic influenza A(H5N1) is included.
- Must be administered in a single healthcare visit or single self-administration event. The vaccine’s active components may be released over time (for example, via slow release or pulsatile release mechanisms). Strategies that rely on the simultaneous administration of separate doses or on a combination of different routes of administration at a single timepoint will not be considered for this prize competition.
- Should include a formulation and/or delivery technology intended to enhance antigen persistence, magnitude, and durability of immune response or controlled antigen/adjuvant release following a single administration.
- Should be an adjuvanted vaccine where the adjuvant is either co-formulated or ad-mixed (bed-side mixing) with the antigen for co-administration/co-delivery.
See the rules, terms, and conditions for entrant eligibility details.
Concept stage evaluation criteria
The degree to which the submission presents an innovative yet feasible single-administration vaccine approach aligned with the Desired Product Attributes and clearly describes how the proposed formulation, adjuvant, and delivery approach is expected to enhance the magnitude, quality, and durability of the immune response to the target antigen(s) following a single administration.
The degree to which the submission presents an achievable nonclinical development strategy aligned with the Desired Product Attributes, including formulation optimization, relevant in vitro characterization, and appropriately designed animal studies to evaluate immunogenicity, durability, and protective efficacy. The proposed studies should include clearly defined success criteria and demonstrate how the formulation will be evaluated throughout development.
The degree to which the submission demonstrates a credible regulatory and manufacturing strategy that supports future clinical translation and is aligned with FDA expectations for IND-enabling development, scalable manufacturing, quality, and CMC development. Prior regulatory experience, where applicable, and a realistic plan for regulatory engagement should be described.
The degree to which the submission demonstrates that the Primary Entrant and any included partners possess and/or have access to the scientific, technical, manufacturing, and operational expertise required to successfully execute the proposed work. The submission should identify key technical and development risks and practical mitigation plans/strategies to address them across the product lifecycle.
Stage 1 evaluation criteria
Submissions will be evaluated against requirements set out in the Desired Product Attributes. Further details will be published prior to the launch of Stage 1.
Stage 2 evaluation criteria
Submissions will be evaluated against requirements set out in the Desired Product Attributes. Further details will be published prior to the launch of Stage 2.
