As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States. The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than 2,000 to 3,000 new cases each day.
Due to the lack of approved therapeutics, vaccines, and diagnostics for this threat, developing new products and testing products already approved for other uses is a high priority for the U.S. interagency response effort—the Medical Countermeasure (MCM) Task Force. The Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), is leading this Task Force in partnership with U.S. Department of Defense, Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health.
BARDA is currently looking at the effectiveness of existing countermeasures for similar viruses, as well as potential new responsive technologies, including vaccines, diagnostics, therapeutics, and medical supplies. BARDA is serving as the sole point of entry for product and technology submissions to ensure there is an expedited process for receipt and review of proposed solutions for 2019-nCoV. In this capacity, BARDA has released two opportunities to submit potential solutions for the 2019-nCoV response discussed below: (1) the EZ-BAA for 2019-nCoV diagnostics and (2) market research packages for any and all potential products and supplies. Covington encourages those with technology that could be potentially useful to respond.
HHS Easy Broad Agency Announcement (EZ-BAA)
An EZ-BAA is now open for abstract submissions for development of an in vitro diagnostic for the detection of 2019-nCoV in clinical specimens. The diagnostic must be developed for use with an existing FDA-cleared molecular platform that is currently widely placed in U.S. healthcare settings, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization within 12 weeks of an award. The number of available awards is unlimited, and any awards are expected to be less than $750,000. Additional details and requirements for submissions are available here, and HHS’ statement on the EZ-BAA is available here. Abstract submissions are due by March 18, 2020 at 5:00 PM EDT.
Market Research Package Submission for Medical Countermeasures (MCMs)
BARDA also created a portal for submission of products or technology for MCM research and development in an effort to cast a wide net for possible responsive technology to 2019-CoV. The interagency response to support domestic preparedness includes four key prongs: (1) MCM development; (2) healthcare system preparedness; (3) supply chain resilience; and (4) medical surge. BARDA is interested in submissions that help the Task Force meet these strategic efforts. Although a non-exhaustive list, BARDA provides in the submission portal that the ideal technologies and products could include the following characteristics:
- Relevant to the U.S. government 2019-nCoV medical countermeasure research and development efforts and/or Emerging Infectious Disease rapid response capabilities
- Utilize an already-approved platform, have non-clinical data suggesting efficacy, and/or have significant manufacturing capability
- Fully owned or licensed by your organization (you have full IP rights and/or freedom to operate)
Categories for submission include vaccines, diagnostics, therapeutics, as well as a broad catch-all category. The Task Force is looking for submissions to encompass a wide variety of MCM approaches, including approaches that allow for an expedited product development pathway that would lead to earlier recognition and isolation of new cases. No deadline is included in the MCM portal, however, potential stakeholders are encouraged to submit as soon as possible.