New Vaccine Platforms (NVP) Program
Special Notice Posted
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Place of performance
- Washington, District of Columbia, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response has published a Special Notice for the New Vaccine Platforms (NVP) Program. This program seeks to identify and advance innovative vaccine platform technologies for the BARDA medical countermeasure portfolio. The initiative targets vaccine platforms that demonstrate safety, effectiveness against multiple infectious disease threats from different pathogen families, and efficient development and manufacturing capabilities. In-scope technologies include protein, viral vector, and bacterial vector-based approaches that have already demonstrated manufacturing capability for Phase 1 clinical trial material. No set-aside has been designated for this opportunity, and the Request for Project Proposals is expected to be open to both individual organizations with complete technology solutions and two-part teams combining complementary capabilities.
The primary objective of the NVP Program is to conduct staged capability demonstrations across at least two emerging infectious disease threats to validate vaccine platform technologies. Eligible offerors may submit as either a single organization offering a full technology solution or as a two-part team consisting of an antigen expression capability provider (Capability A) and a vaccine carrier/formulation capability provider (Capability B). The program encompasses three demonstration stages: CD-1 focusing on manufacturing through Phase 1 clinical trial material production, CD-2 addressing nonclinical activities supporting Phase 1 IND applications, and CD-3 conducting Phase 1 clinical trials. Initial demonstration threats include Lassa virus, Nipah virus, chikungunya virus, and West Nile virus, with additional opportunities for demonstration against pandemic influenza targets and other infectious disease threats aligned with BARDA's Chemical, Biological, Radiological, and Nuclear Defense Division mission.
Notice text
The New Vaccine Platforms (NVP) Program aims to identify new vaccine platforms for the BARDA medical countermeasure (MCM) portfolio and advance them through a staged capability demonstration to identify technologies that (1) are safe; (2) are effective across multiple infectious disease threats from different pathogen families; and (3) enable efficient development and manufacturing.
In-scope platform technologies notionally include protein, viral vector, and bacterial vector-based approaches that have demonstrated manufacturing of Phase 1 clinical trial material (CTM). The Request for Project Proposals is expected to be open to Offerors that are either (1) a single organization with a full technology solution or (2) a two-part team that together offer a full technology solution comprised of an antigen expression capability (Capability A) and a vaccine carrier/formulation capability (Capability B).
The objective of the NVP Program is to conduct a staged capability demonstration (CD) across at least two (2) emerging infectious disease (EID) threats. CD stages include: (CD-1) manufacturing demonstration (all work from start to Phase 1 CTM); (CD-2) nonclinical demonstration (all critical path activities to support a Phase 1 IND; e.g., safety, immunogenicity, efficacy); and (CD-3) clinical demonstration (Phase 1 trial). Threat options are informed by the BARDA mission and the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) priority biological threats, which includes select Emerging Infectious Diseases (EID) families or groups. Options for initial demonstration across two (2) EID threats notionally include: Lassa virus; Nipah virus; chikungunya virus; or West Nile virus. Additional options for further demonstration may include a to-be-determined (TBD) pandemic influenza target and a TBD infectious disease threat aligned to the BARDA CBRN Division mission.
Advancing vaccine platforms that are safe, broadly protective across multiple infectious disease threats, and enable streamlined development and manufacturing will help ensure the U.S. MCM portfolio is optimally positioned to respond efficiently and effectively to national health security incidents.
Similar open opportunities
| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA) | Office of the Assistant Secretary for Preparedness and Response | No set-aside |
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