Expanding the Coronavirus Disease 2019 (COVID-19) Response through Diagnostic Development

In the latest World Health Organization daily situation report, as of March 11, 2020, the WHO reported 118,326 COVID-19 cases confirmed and 4,292 deaths worldwide, and the U.S. Centers for Disease Control and Prevention (CDC) reported 938 cases and 29 deaths in the United States.  The same day, WHO characterized COVID-19 as the first global pandemic sparked by a coronavirus.  Additionally, the Secretary of the U.S. Department of Health and Human Services (HHS), issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to provide liability immunity for entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of covered medical countermeasures (MCMs).  Prioritized pathways are now available to expedite review of new, responsive technology proposals for MCMs from diagnostics to therapeutics.

In a previous post, we announced the Biomedical Advanced Research and Development Authority (BARDA)’s launch of an Easy Broad Agency Announcement (EZ-BAA) particularly created for the COVID-19 response.  Since then, BARDA has expanded the EZ-BAA’s scope to seek new diagnostic submissions.  In addition, BARDA narrowed the scope of a pre-existing BAA to prioritize areas of interest that support the novel coronavirus response.  Both submission opportunities are described in further detail below.

BARDA, under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in HHS, continues to be the sole federal agency point of entry to expedite review and approval of COVID-19 proposal submissions.  In that capacity, BARDA continues to solicit market research packages and encourages interested stakeholders to submit their research on COVID-19 MCMs.  BARDA emphasizes that SARS-CoV-2, the virus that causes COVID-19, is the third coronavirus in less than 20 years, prompting the need for rapid development of responsive solutions.

We continue to monitor the legal, regulatory and commercial implications of COVID-19, and Covington has launched the COVID-19 Legal and Business Toolkit to help clients keep apprised of key developments.

Expanded EZ-BAA to Include Diagnostics

In February, BARDA announced new public-private partnerships to develop MCMs for COVID-19, including vaccine candidates and therapeutics for those already infected with SARS-CoV-2.  BARDA is continuing to seek submissions to create new public-private partnerships and has also broadened the possible responsive technologies to include “abstracts for nonclinical assays and models to support the development of multiple medical countermeasures.”  In addition to MCMs, BARDA is also prioritizing accurate, timely diagnostics.  To support that priority, a streamlined EZ-BAA for COVID-19 for molecular diagnostics is now available.  Key requirements include that diagnostic submissions must leverage FDA-cleared platforms and have a viable plan to meet requirements for the FDA to consider Emergency Use Authorization within 12 weeks of an award.

The EZ-BAA will be open for submissions until March 18, 2020 at 5:00 PM EDT, unless otherwise extended.  Available awards are expected to be less than $750,000 per project.

Focused Areas of Interest for COVID-19 and SARS-CoV-2 Infection Response

On March 9, 2020, BARDA also adapted its pre-existing BAA to prioritize proposal submissions for COVID-19 response.  BARDA is focusing on the following areas of interest:

  • AOI 7.7.1 Diagnostic assay for human coronavirus using existing FDA-cleared platforms
  • AOI 7.7.2 Point-of-care diagnostic assay for detection of SARS-CoV-2 virus
  • AOI 7.7.3 Diagnostic assay for detection of COVID-19 disease (SARS-CoV-2 infection)
  • AOI 8.3 COVID-19 Vaccine
  • AOI 9.2 COVID-19 Therapeutics
  • AOI 9.3 Immunomodulators or therapeutics targeting lung repair
  • AOI 9.5 Pre-exposure and post-exposure prophylaxis
  • AOI 10 Respiratory Protective Devices
  • AOI 11 Ventilators
  • AOI 17 Advanced Manufacturing Technologies

All other proposals for areas of interest unrelated to COVID-19 will be placed in a queue for later review.  The BAA is open to all responsible offerors, which include single entities or teams from private organizations, Government laboratories, and academic institutions.  Multiple awards of various values are anticipated dependent upon the program’s priorities and available funds, and BARDA may award any appropriate contract type under the FAR or Other Transactions Authority (OTA).  BAA Submission occurs in two stages:  Stage 1 requires submitting a Quad Chart and White Paper; Stage 2 requires submitting a Full Proposal.  For more information about the BARDA BAA submission process please visit ASPR’s website or the System for Award Management.  The submission deadline under this BAA is October 31, 2020.

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