The Patch Forward Prize, part of Project NextGen, is a $50 million competition to advance microneedle patch-based RNA vaccines for COVID-19, seasonal influenza, and pandemic influenza. The Biomedical Advanced Research and Development Authority (BARDA) calls on vaccine developers and patch makers to partner and accelerate new vaccine technologies.
About the prize
The need
When it comes to vaccines, America needs options.
The modern syringe has existed for more than 170 years, and to this day, is the dominant vaccine administration method. However, there are multiple reasons to look beyond the needle.
To begin with, the fear of needles contributes to vaccine hesitancy. Prefilled syringes and vials also require complex cold chain storage and transport, limiting access and requiring administration by trained healthcare providers. Beyond patient fears and logistical challenges, administering vaccines via intramuscular injection may not be the most efficient method of eliciting protective and durable immunity against infection.
The opportunity
Now is the time for vaccine innovation.
Intradermal vaccination using patches may help address a number of limitations associated with existing vaccines and immunization programs. Microneedle patches, also known as microarray patches, are applied to the skin like a small adhesive disc or bandage. These patches have microscopic projections that penetrate the skin’s surface, delivering vaccines into the top layers of the skin. The skin is the body’s natural barrier to external harms, and it is enriched with a multitude of immune cells that respond potently to vaccination. These strong immune responses lead to durable protection, which may make patch-based vaccines more cost-effective and dose-sparing at scale, as they might require less of the active ingredient.
Patch-based vaccines could simplify the process of formulation, storage, transport, and administration. A patch-based vaccine may have improved stability, reducing the need for refrigeration or freezing prior to administration. Patch-based vaccines are designed to be self-contained products, eliminating the need for liquid reconstitution in glass vials and reducing supply chain disruption risks. Patch-based vaccines also have the potential for administration by non-healthcare personnel, or even self-administration, which could improve access and increase immunization coverage, especially during public health emergencies.
The COVID-19 pandemic ushered in a new era of vaccine development, with the first two messenger RNA (mRNA) vaccines granted authorization and full licensure by the U.S. Food and Drug Administration. Traditional vaccines work by delivering the immune system an antigen, which can be a part of the disease-causing pathogen, or the whole pathogen treated so that it cannot cause disease. Rather than introducing the body to the antigen itself, RNA vaccines deliver a set of genetic instructions, giving cells the ability to produce antigens that stimulate an immune response.
RNA vaccines allow for rapid design, production, and deployment, which is critical when responding to novel infectious diseases. Innovation in the field of RNA vaccines and alternative routes of vaccine administration can address existing limitations.
The vision
There will be another pandemic, and we want to be ready for it.
Scientists estimate the risk of another COVID-like pandemic is increasing. Microneedle patches have potential to reshape how vaccines are administered: Novel methods of vaccine administration will provide individuals with optionality, while addressing logistical challenges. This new strategy of developing patch-based RNA vaccine combination products has the potential to increase vaccine equity, maximize immunization coverage, and reduce the risk of morbidity and mortality due to infectious diseases.
Ensuring the compatibility of RNA with patches for vaccine administration presents technical challenges; to date, no patch-based vaccine combination product has gained regulatory approval. In addition to technical hurdles, there is also a significant structural challenge to overcome: Bringing these combination products to market will require new partnerships between RNA vaccine developers and patch makers.
The Patch Forward Prize is a unique funding mechanism to foster industry collaboration and support the advancement of patch-based vaccine candidates toward the completion of Phase I clinical trials. By demonstrating the safety and immunogenicity of patch-based RNA vaccines in humans, the prize will accelerate breakthroughs in vaccine technology. This is a unique moment in time. Vaccine developers and patch makers have an opportunity to advance novel strategies that will better protect the nation against future pandemic threats.
Patch Forward Prize stages
Overview
The Patch Forward Prize will foster collaboration and provide resources to support the first effective demonstrations of patch-based RNA vaccines through Phase I clinical trials.
Concept Stage: Development plans
The Concept Stage of the prize called on all eligible entrants — namely RNA vaccine developers and patch makers engaging in strategic partnerships — to submit concept papers detailing their respective technologies, proposed product, plans for development, and functional testing. The concept papers were expected to address key considerations for product development and formulation, regulatory review and approval, preclinical and clinical evaluation, and manufacturing processes to advance a safe, tolerable, and immunogenic patch-based RNA vaccine. The vaccine product must have included at least one of the following indications: COVID-19, trivalent or quadrivalent seasonal influenza, and/or pandemic influenza A/H5N1. The vaccine product may also target any other indications concurrently, as long as it included at least one of the required indications listed above.
- Entrants submitted concept papers of no more than 10 pages.
- Submissions needed to describe the proposed product, including any supporting evidence from development and evaluation efforts to date.
- Entrants could submit more than one concept paper, as long as each concept paper described a unique combination product.
- The proposed product needed to be a single patch intended for intradermal RNA vaccine administration. For the purposes of the prize, a patch is a vaccine delivery system that is applied to the body like a small adhesive disc or bandage, and consists of microscopic projections that penetrate the skin surface.
- Entrants needed to demonstrate as part of their submission that they had access to the required intellectual property for both the RNA vaccine and patch technology platforms, or a documented pathway to acquire that access.
- Submissions needed to include an ambitious but achievable development plan. Entrants were required to define their functional immune assay(s) and criteria for success, with a brief rationale behind the criteria for success for each assay. Submissions needed to include a detailed approach to all required preclinical and clinical activities, including:
- Preclinical toxicology and immunogenicity study plans.
- Phase I clinical trial design synopsis, and an overall plan for advancing the proposed combination product through completion of a Phase I clinical study that demonstrates safety, tolerability, and immunogenicity in humans.
- Approach to establishing Chemistry, Manufacturing and Controls (CMC), and Good Manufacturing Practice (GMP) for manufacturing consistency of the combination patch-based RNA vaccine that will enable testing in humans.
An expert judging panel evaluated and scored submissions according to Concept Stage evaluation criteria. Based on this evaluation, the judging panel will recommend up to four Concept Stage winners, each of whom will receive a $2 million award from the $8 million Concept Stage prize pool.
At the end of the Concept Stage, winners may be invited to showcase their proposed product to the judging panel and other stakeholders at a Demo Day event.
Preclinical Stage: Investigational New Drug (IND) application enabling studies
Innovative RNA vaccine developers and patch makers that have developed preclinical study plans are invited to participate in the Preclinical Stage. Entrants are not required to compete in the Concept Stage to be eligible to enter the Preclinical Stage of the prize.
Declarations of intent
Prospective entrants must declare their intent to compete in the prize by providing their preclinical study plans to the Patch Forward Prize. Based on review of this declaration, the prize will accept qualifying entrants into the Preclinical Stage.
Preclinical Stage technical papers
Once accepted, Preclinical Stage entrants should submit technical papers detailing outcomes of preclinical activities required for clinical development of a patch-based RNA vaccine. The vaccine product must include at least one of the following indications: COVID-19, trivalent or quadrivalent seasonal influenza, and/or pandemic influenza A/H5N1. The vaccine product may also target any other indications concurrently, as long as it includes at least one of the required indications listed above.
- Entrants should submit a technical paper of no more than 25 pages.
- Preclinical Stage submissions should provide a data package describing the outcomes of completed IND-enabling preclinical activities, containing evidence that entrants met their defined functional immune assay success criteria. Submissions should also provide a detailed outline of regulatory engagement activities, including pre-IND meeting(s) and evidence of favorable FDA responses to preclinical activities and results, as well as clinical study plans.
- Entrants must demonstrate as part of their submission that they have continued access to the required intellectual property for both RNA and patch technology platforms.
- Prospective entrants may have access to technical assistance that will support their completion of these activities.
Eligible submissions will be evaluated in the order they are received. An expert judging panel will assess submissions according to Preclinical Stage evaluation criteria. The judging panel will recommend the first three submissions that meet the evaluation criteria for Preclinical Stage awards. Up to three Preclinical Stage winners will each receive a $7 million Preclinical Stage award.
Preclinical Stage details are subject to change based on the results of Concept Stage. Any changes will be announced prior to the launch of Preclinical Stage.
Clinical Stage: Phase I clinical trials
Innovative RNA vaccine developers and patch makers that are planning to initiate Phase I clinical trials for a qualifying patch-based RNA vaccine are invited to participate in the Clinical Stage. Entrants should be ready to submit an Investigational New Drug (IND) authorization for a clinical protocol that has not previously been filed with the FDA. Entrants are not required to participate in the Concept Stage or the Preclinical Stage to be eligible to enter the Clinical Stage of the prize.
Declarations of intent
Prospective entrants who will submit for an Investigational New Drug (IND) authorization for use of their proposed product in human trials must declare their intent to compete in the prize by providing their clinical study plans and an entrant-defined target product profile (TPP) to the Patch Forward Prize. Based on review of this declaration, the prize will accept qualifying entrants into the Clinical Stage.
Clinical Stage technical papers
Once accepted, Clinical Stage entrants should submit technical papers detailing outcomes of their Phase I clinical trial for a patch-based RNA vaccine. The vaccine product must include at least one of the following indications: COVID-19, trivalent or quadrivalent seasonal influenza, and/or pandemic influenza A/H5N1. The vaccine product may also target any other indications concurrently, as long as it includes at least one of the required indications listed above.
- Entrants should submit a technical paper of no more than 25 pages.
- Clinical Stage submissions should provide evidence that entrants met success criteria for their defined functional immune assay.
- Clinical Stage submissions should supply a data package consisting of results from completed Phase I studies, including a complete Clinical Study Report (CSR) synopsis outlining the safety, tolerability, and immunogenicity findings from analysis of final data sets. Submissions should also provide data on established manufacturing processes that demonstrates manufacturing consistency during the Phase I clinical study.
- Clinical Stage submissions should include any evidence of progress made by the proposed product to meet the criteria from the entrant-defined TPP.
- Prospective entrants may have access to technical assistance that will support their completion of these activities.
Eligible submissions will be evaluated in the order they are received. An expert judging panel will assess submissions according to Clinical Stage evaluation criteria. Multiple evaluation periods will be opened and closed during the Clinical Stage; specific dates will be published prior to the Clinical Stage launch. The judging panel will recommend the first two submissions that meet the evaluation criteria for Clinical Stage awards. Up to two Clinical Stage winners will each receive a $10.5 million Clinical Stage award.
Clinical Stage details are subject to change based on the results of the Concept Stage and Preclinical Stage. Any changes will be announced prior to the launch of the Clinical Stage.