March 6, 2020
HHS Solicits Proposals for Development of Medical Products for Novel Coronavirus
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 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, 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.
“Amid the expanding global outbreak of COVID-19, Americans need diagnostics, vaccines, and medicines to mitigate the potential impact of this virus”, said BARDA Director Rick Bright, Ph.D. “To accelerate the availability of these lifesaving tools, BARDA took an important step today to request proposals for development of COVID-19 diagnostics, vaccines, or therapeutics, many of which will be developed using existing platform technologies to permit rapid development.”
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.
There are currently no approved diagnostics, vaccines or treatments for COVID-19 infections. However, the U.S. Food and Drug Administration (FDA) issued two emergency use authorization of diagnostic tests from the Centers for Disease Control and Prevention (CDC) and other authorized public health laboratories, and for use of New York State’s Wadsworth diagnostics test. In addition, FDA also issued a new policy Feb. 29 to help expedite the availability of diagnostics.
HHS continues to work across the U.S. government, including with the Department of Defense, to review potential products from public and private sectors to identify promising candidates that could detect or protect against or treat COVID-19 for development and licensure. HHS divisions, including the National Institutes of Health (NIH) and ASPR, have begun supporting development of multiple vaccines and treatments for COVID-19.
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.
About HHS, ASPR, and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance.