NEW VACCINE PLATFORMS (NVP) PROGRAM

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.