![]() Vaccines delivered via alternate routes of administration would have similar or superior performance characteristics as traditional parenterally administered vaccines (i.e. Ideal attributes for vaccines delivered via alternative routes of administration would be single dose, room temperature stable, unadjuvanted and indicated for all populations. 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.īARDA 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. Traditional vaccinations using needles and syringes are the primary intervention for prevention of infection. Vaccination is the single most effective public health intervention for preventing the spread of infectious diseases. **Priority will be given to products manufactured in the United States.ĪOI #4.3: Alternative Routes of Administration (AROA) for Vaccines Demonstrates a clear commercialization strategy.Achieved FDA regulatory clearance/approval or have identified a clear regulatory path for deployment, if applicable to technology.Requires minimal infrastructure or training to deploy and support.Significant preliminary COVID-19 data to support utility of technology for COVID-19.Software tools should be able to be integrated into EHRs or deployed in less than 30 days.After clinical validation, technology should have the ability to be rapidly scaled and deployed under an accelerated timeline of less than 90 days Total period of performance should have impact for this current COVID-19 outbreak.Respondents should have a need to assess clinical validation through conducting a pilot study that meets the following requirements: Please note! Pathogen-targeted, serology diagnostics, and bench-top diagnostics, are not of interest for this topic at this time. In addition, technologies that incorporate novel informatics approaches to data collection, reporting, and analysis are of interest. 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. 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. There is also a need to rapidly assess and diagnose illness severity so patients can be triaged for care. ![]() These include technologies that empower patients through self-monitoring, or providers through remote monitoring or evaluation and diagnostic capability throughout the continuum of care. BARDA is extending the expiration date for its temporary AOI #4: COVID-19 as part of its EZ-BAA to 31 October 2020ĪOI #4.1-D: Remote Patient Monitoring/Remote Diagnostic ToolsīARDA 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.
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