BARDA’s Actions on the Virus

The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) https://www.phe/gov is working with Sanofi Pasteur, the vaccines global business unit of Sanofi https://www.sanofi.com.

The Biomedical Advanced Research and Development Authority (BARDA)  https://phe.gov/about/barda/pages/default.aspx, a component of ASPR, will provide expertise and reallocated funds to support the 2019 coronavirus vaccine’s development.

BARDA is also working with counterparts across the government within HHS and the Department of Defense https://www.defense.gov to review potential vaccines, treatments, and diagnostics across public and private sectors.

The Federal agencies are particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, and/or have utilized a platform already approved by FDA.

To obtain information about potential products in development in the private sector that could be used to respond to the novel coronavirus outbreak, the U.S government has launched a single point-of-entry website for innovators and product developers. They will be able to submit brief descriptions of their diagnostics, therapeutics, vaccines, and another products or technologies relevant to this new virus.

BARDA has also opened an “Easy Broad Agency Announcement” (EZ-BAA) specific to diagnostics that utilize platforms already cleared by FDA with a viable plan to meet requirements for FDA to consider “Emergency Use Authorization” (EUA) within 12 weeks of an award.

Companies can submit their abstracts if the company has an innovative coronavirus diagnostic or nonclinical assays underway. Go to https://drive.hhs.gov/partner.html#ncov to find out more information on how to submit an abstract.