RPP # | Requirement Topic | Description | Requiring Office | Submission Due Date |
---|---|---|---|---|
Q3FY24 RPP | Project NextGen: On Demand Manufacturing | Slides from the On Demand Manufacturing Virtual Industry Day (1/16/2024) Available Here | TBD | |
Q3FY24-Q4FY24 | Oral Formulation Vaccine | Early development of oral formulation COVID-19 vaccines in a proof-of-concept Phase 1 study under the US FDA and potentially IND-enabling studies to support the Phase 1. The investigational vaccine should demonstrate, at minimum, non-inferior immunogenicity compared to vaccine(s) administered via the traditional needle/syringe route. Oral COVID-19 vaccines using any of the following platforms will be considered: mRNA; recombinant protein; virus-like particle; or viral vector. | TBD | |
Q3-Q4FY24 | mRNA Vaccine Platform Production Capability for Rapid Pandemic and Priority Threat Response | The requirements for mRNA Vaccine Platform Production Capability for Rapid Pandemic and Priority Threat Response are being redefined. As we redefine the requirements, we will actively communicate updates. | IEID | TBD |
RPP # (Date) | Requirement Topic | Closed Date |
---|---|---|
RPP-24-07-CentralIEIDLab (06/14/2024) | Central Influenza and Emerging Infectious Diseases Vaccine Immunogenicity Laboratory Services | 07/15/2024 |
RPP-24-06-DxR2 (3/27/2024) | Biothreat Diagnostic Rapid Response | 5/17/2024 |
RPP-24-03-Treatment (02/21/2024) | Project NextGen: Therapeutics | 5/13/2024 |
RPP-24-05-NGClinMfg (01/16/2024) | Project NextGen: Innovation in Clinical Manufacturing of COVID-19 Vaccines | 04/19/2024 |
RPP-24-04-NGVxStats (2/23/2024) | NextGen Vaccines: Statistical Support, Correlates of Protection, and Meta-analysis | 03/27/2024 |
RPP-24-04-NGVxAssays (2/15/2024) | NextGen Vaccines: Immune Assays | 3/22/2024 |
RPP-24-02-Retail (2/2/2024) | Enabling Technology – Decentralized Clinical Trial – Retail/Pharmacy Focus | 03/20/2024 |
RPP-24-03-PrEP (11/30/2023) | COVID-19 Monoclonal Antibody Therapeutics for PrEP | 01/19/2024 |
RPP-24-02-HomeFocus (11/30/2023) | Enabling Technology – Decentralized Clinical Trial – Home Focus | 01/19/2024 |
RPP-24-04-NGVx (11/30/2023) | NextGen Vaccinations: Phase 2B Clinical Trial Execution | 01/10/2024 |
RPP-24-01-mRNA | Accelerating Near-Term Availability of mRNA-based Pandemic Influenza Vaccine | 12/4/2023 |