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BAA for COVID-19 Diagnostics, Vaccines and Therapeutics

As part of the government-wide effort to mitigate the spread of COVID-19 in U.S. communities, the U.S. Department of Health and Human Services (HHS) has updated a broad agency announcement (BAA) to focus specifically on products to diagnose, prevent or treat novel coronavirus infections.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), issued the BAA-18-100-SOL-00003-Amendment 13 to solicit proposals for advanced development and licensure of COVID-19 diagnostics, vaccines, or medicines such as therapeutics or antivirals.

BARDA will provide funding as well as expertise and core services to support development projects selected through this BAA. These products include diagnostic tests (assays); vaccines; therapeutics; medications to help regulate or normalize the immune system (immunomodulators); therapeutics targeting lung repair; medicines that prevent infections either before or after exposure to the virus (pre-exposure or post-exposure prophylaxis); respiratory protective devices; and ventilators.

COVID-19 response related Areas of Interest includes:

  • 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

BARDA will only accept submissions related to the SARS-CoV-2 virus or the COVID-19 disease until further notice.

The final white paper submission deadline is October 31, 2020. The final full proposal submission deadline is October 31, 2020 or as specified in the invitation letter.

Offers Due: Apr 30, 2020 04:30 pm EDT. The final full proposal submission deadline is October 31, 2020 or as specified in the invitation letter.

To obtain information about any potential products in development in the private sector that could be used in responding to the novel coronavirus outbreak, the U.S. government launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies being developed for COVID-19.

To shorten the time to apply for product licensure and to reduce the spread of COVID-19, federal agencies are particularly interested in identifying products and technologies that have progressed beyond non-clinical studies, have established domestic large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, and have utilized a platform used to manufacture a product already approved by the FDA.

In addition, BARDA opened an easy broad agency announcement, an EZ-BAA, seeking diagnostics that utilize platforms already cleared by the FDA, with a viable plan to meet requirements for the FDA to consider emergency use authorization within 12 weeks.

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