What the FY2027 request buys
Verbatim from the R-2A exhibit for project PT3 of PE 0603384BP. This is the budget justification's own description of work that has not happened yet — the one thing no other level of the budget carries.
- Transition broad spectrum vaccine to advanced development for Phase 1 clinical trial. - Complete nonclinical studies for two multivalent vaccine platforms using representative pathogens. - Continue development of oral, broad spectrum mRNA vaccine. - Continue preclinical development of marine toxin antibody cocktail for transition to advanced development. - Continue development of broad spectrum platform that protects against neurotoxins and nerve agents. - Initiate testing of commercial alternative testing platforms for ability to predict effectiveness of vaccines. - Continue development of multiple threat agnostic prophylactic products both as stand alone and in conjunction with other medical countermeasures in a layered approach.
Decrease reduces the number of pre-clinical and Good Manufacturing Practice (GMP) manufacturing medical countermeasure candidates and focuses on sequential development of protective medical countermeasures.
FY2025–FY2026: what came before
Prior-year accomplishments and current-year plans from the same exhibit. Context for the FY2027 plan, not a series — an activity partitions its project exactly in the request year, but can under-cover it in earlier years.
- Complete preclinical studies and manufacturing for multivalent vaccine. - Complete the non-clinical safety studies and manufacturing process development for the Nipah Viral Replicon Particles (VRP) vaccine and transition it to Project PT4/Protect (Advanced Component Development & Prototypes) Vaccine Acceleration by Modular Progression (VAMP) Program. - Continue preclinical development of multiple broad spectrum and multivalent vaccine platforms and toxin monoclonal antibodies (mAbs). - Development of artificial intelligence (AI)/ machine learning (ML) predictive model using data from studies evaluating novel vaccine platforms. - Continue to improve manufacturing process development and scale up for toxin antibodies and multiple prophylactic platform technologies. - Initiate testing and evaluation of vaccines on novel prophylactic platforms.
- Completed Phase 1 clinical trial for a nucleic acid vaccine candidate that will transition to advanced development. - Completed GMP manufacturing process development and continued preclinical studies for a pan-Alphavirus vaccine using a modernized inactivation platform for eventual transition to advanced development. - Continued nonclinical development of multiple broad spectrum and multivalent vaccine platforms and toxin monoclonal antibodies (mAb) for transition to advanced development. - Data from preclinical studies was transitioned into the vaccine predictive tool to enhance computational predictions of how to use these platforms in rapid response scenarios. - Continued development and establishment of safety/efficacy models for Food and Drug Administration (FDA) approval.
Three years, and no five-year plan
An R-2A activity publishes the prior year, the current year and the budget year. The FYDP outyears exist at project and program-element level and are deliberately absent here rather than inferred. Estimate types are colored and never summed into one figure.
| Fiscal Year | Estimate Type | Amount ($M) |
|---|---|---|
| FY2025 | Actual | 23.8 |
| FY2026 | Enacted | 27.9 |
| FY2027 | Request | 23.6 |
This activity is 41% of project PT3's FY2027 request and 7.6% of PE 0603384BP's. In the request year the activities under a project sum to it exactly; in the current year they under-cover it in about 9% of cases, so an activity's delta can legitimately exceed its parent's and the two must not be compared row to row.
10 activities in project PT3
Every R-2A line of this project, largest FY2027 request first. Linked where the activity has enough of its own narrative to carry a page; the rest are shown in full on the project page.