Extension for BARDA EZ BAA: Temporary AOI#14 (COVID-19)
BARDA is extending the expiration date for its temporary AOI #4: COVID-19 as part of its EZ-BAA to 31 October 2020
AOI #4.1-D: Remote Patient Monitoring/Remote Diagnostic Tools
BARDA is looking for diagnostic technologies with near-term impact to improve efficiency and effectiveness of the health infrastructure in the US during the current outbreak. These include technologies that empower patients through self-monitoring, or providers through remote monitoring or evaluation and diagnostic capability throughout the continuum of care. There is also a need to rapidly assess and diagnose illness severity so patients can be triaged for care. These technologies may include smartphone applications, wearables, non (or minimally) invasive sensors to measure/monitor host-signature or diagnose response to infection, telehealth, EHR-based tools, algorithms that can predict, identify or prognosticate risk trajectories, clinical decision support software, or continuous monitoring devices.
These technologies should be in advanced development and ready for clinical validation and capable of capturing and quantifying a broad range of host biological, immunological, biometric, clinical, laboratory, and/or physiological data. In addition, technologies that incorporate novel informatics approaches to data collection, reporting, and analysis are of interest.
Please note! Pathogen-targeted, serology diagnostics, and bench-top diagnostics, are not of interest for this topic at this time.
Respondents should have a need to assess clinical validation through conducting a pilot study that meets the following requirements:
- Total period of performance should have impact for this current COVID-19 outbreak. After clinical validation, technology should have the ability to be rapidly scaled and deployed under an accelerated timeline of less than 90 days
- Software tools should be able to be integrated into EHRs or deployed in less than 30 days
- Significant preliminary COVID-19 data to support utility of technology for COVID-19
- Requires minimal infrastructure or training to deploy and support
- Achieved FDA regulatory clearance/approval or have identified a clear regulatory path for deployment, if applicable to technology
- Demonstrates a clear commercialization strategy
**Priority will be given to products manufactured in the United States.
AOI #4.3: Alternative Routes of Administration (AROA) for Vaccines
Vaccination is the single most effective public health intervention for preventing the spread of infectious diseases. Traditional vaccinations using needles and syringes are the primary intervention for prevention of infection. An identified risk during a pandemic response, including SARS-CoV-2, is the availability of needles and syringes and the availability of qualified personnel for vaccine administration. A successful alternative technology for vaccine administration would reduce the demand qualified personnel to administer vaccine.
BARDA is seeking abstracts for the development of alternative routes of administration for vaccines (including oral, transdermal) against CBRN threats, Influenza (seasonal/pandemic), SARS-CoV1 / 2, or MERS-CoV. Ideal attributes for vaccines delivered via alternative routes of administration would be single dose, room temperature stable, unadjuvanted and indicated for all populations. Vaccines delivered via alternate routes of administration would have similar or superior performance characteristics as traditional parenterally administered vaccines (i.e. safety and efficacy).
Although the technology for alternate routes of administration of vaccines are not expected to adhere to TRLs, it is expected that the respondent obtains and submits an Investigational New Drug (IND) application upon completion of BARDA DRIVe funding for this project or the respondent shall make the vaccine available for potential toxicology and efficacy assessments under separate USG mechanisms.
All submissions must include:
- A vaccine candidate against CBRN threats, Influenza (seasonal/pandemic), SARSCoV-1 / 2, MERS-CoV, or partnership with an antigen developer to be administered by an alternate route of administration.
- Plans for IND enabling pre-clinical studies or provide existing data.
- Product development plan.
- Any regulatory communication with US FDA (pre-IND/IND).
- Any pre-clinical or clinical data using this platform.
**Priority will be given to products manufactured in the United States