Advancing effective single-administration pandemic influenza A(H5N1) vaccines is a strategic investment that addresses a specific, high-consequence threat while potentially yielding innovative platforms applicable to other diseases.
FAQs & resources
Program overview and rationale
What are the main goals of the Single Shield Prize?
The Single Shield Prize is a competition to advance single-administration vaccine platforms for pandemic influenza A(H5N1). The prize calls for innovative solutions enabling the development of vaccines that could provide protection in only one visit. By supporting promising technologies through nonclinical studies, the Single Shield Prize aims to accelerate the development of effective single-administration pandemic influenza A(H5N1) vaccines that can be rapidly deployed during an influenza pandemic. Read more about the prize background.
Why is BARDA using a prize competition structure to support innovative single-administration vaccine development?
To advance development of a single-administration vaccine that will protect against pandemic influenza A(H5N1), vaccine developers will need to demonstrate immunogenicity, efficacy, and safety in nonclinical studies while developing scalable manufacturing processes. Doing so will require collaboration across different fields of expertise, technological innovation, and strategic planning. The prize competition model encourages participation from both traditional and non-traditional innovators and supports collaboration, expanding the pool of creative and feasible solutions. Read more about the prize structure and program stages.
Scientific scope
What specific types of vaccines are allowed?
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.
What methods of administration are allowed?
The proposed vaccine candidate must only be administered by the following methods: intramuscular, intradermal, transdermal, subcutaneous.
What vaccine targets are allowed?
The proposed vaccine candidate 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.
Does the vaccine candidate absolutely have to be single-administration? Can an entrant focus on other approaches such as simultaneous administration?
The proposed vaccine candidate 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.
Eligibility and participation rules
Who is eligible to apply?
The Primary Entrant must be a U.S.-based Concern at the time the Declaration of Intent is submitted and remain a U.S.-based Concern through the issuance of prize awards.
“U.S.-based Concern” means: (i) incorporated in the United States (including a U.S.-incorporated subsidiary even if the parent is foreign based), or (ii) unincorporated with its principal place of business in the United States. Principal place of business is defined as the primary location where management directs, controls, or coordinates the entity’s activities.
Components of the work may be performed by a team consisting of subcontractors, consultants, CROs, or partner organizations, however, the Primary Entrant must retain responsibility for substantively leading the technical effort.
Does an applicant need to be at a certain stage of development to be eligible for the Concept Stage?
There is no minimum readiness or stage of development requirement for entrants or their proposed vaccine candidate. Operational readiness is included in the Concept Stage evaluation criteria on which submissions will be assessed.
Is participation in a prior stage(s) required to be eligible for entry into a subsequent stage?
Stage 1 is open to winners of the Concept Stage (Stage 0) and to new entrants who meet the eligibility requirements.
Only Stage 1 winners will be eligible to progress to Stage 2.
If an entrant applies to — but does not receive the prize for — a given stage, are they eligible to apply for a subsequent stage?
An entrant may enter or re-enter the prize competition at Stage 1, provided they meet the eligibility criteria. For Stages 0 and 1, entrants must submit and receive approval of a Declaration of Intent to be eligible for prize awards.
For Stage 2, only Stage 1 winners are eligible for prize awards.
Will entrants be notified of approval to proceed following submission of a Declaration of intent for the Concept Stage?
Entrants will be notified whether they have received approval to submit a concept paper within 5 business days of submitting a Declaration of Intent. No additional details or feedback will be provided to entrants who do not receive approval.
Can an entrant submit more than one submission for the same stage?
Entrants may submit more than one entry to each stage, however, each Primary Entrant or entrant team may only be selected for one award per stage.
What are the evaluation criteria?
Evaluation criteria will be published at the opening of each stage. View the criteria for the Concept Stage.
Will unsuccessful entrants receive feedback on their submissions?
Notifications to unsuccessful entrants will be made via email after the notification to the winner(s). No additional details or feedback will be provided to unsuccessful entrants.
Do I need a SAM.gov registration?
No.
Are federal government (USG) employees and USG support contractors eligible to participate in submissions?
No. USG employees and support contractors are not eligible to be part of a submission in any capacity – whether as Primary Entrants, team members, collaborators, advisors, or any other role, and whether paid or unpaid.
An entrant shall not be deemed ineligible because the entrant used federal facilities or consulted with federal employees during the prize if the facilities and employees are made available to all entrants participating in the prize on an equitable basis.
Are foreign subcontracts/collaborators permitted?
The Primary Entrant must be a U.S.-based Concern at the time the Declaration of Intent is submitted. Foreign subcontractors and teaming partners may be included, provided they comply with the eligibility requirements. See the official rules, terms, and conditions for complete information on eligibility.
Does an applicant already need to be a U.S.-based entity at the time of submitting the Concept Stage application?
The Primary Entrant must be a U.S.-based Concern at the time the Declaration of Intent is submitted and remain a U.S.-based Concern through the issuance of prize awards. See the official rules, terms, and conditions for complete information on eligibility.
Are the Single Shield Prize awards intended to cover all project costs, or only direct costs?
The stage awards are paid to entrants who are selected as winners under the prize rules, terms, and conditions. Unlike a grant or contract, a prize is not a cost-reimbursement mechanism and is not based on direct, indirect, proposed, or incurred costs. It is expected that winners will use the prize funds to support further development and participation in subsequent stages of the prize, or toward execution of a Phase 1 clinical trial in the case of Stage 2 winner(s).
Desired Product Attributes
Evaluation will be informed by the Desired Product Attributes (DPA), which describe product requirements and target nonclinical metrics aligned with approved two-dose pandemic influenza vaccines.
Evaluation criteria
Submissions will be evaluated based on the evaluation criteria for each stage. View the evaluation criteria.
Still have questions?
Contact us at Hello@SingleShieldPrize.com.
