Type: Sources Sought To: Prospective Partners & Interested Parties The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from current and potential biopharmaceutical partners. Information collected from this RFI will serve as continued market research for a possible program where BARDA would partner with multiple organizations to achieve the pandemic preparedness goals set forth by the U.S. Government (USG). Background: Within the USG, HHS/ASPR/BARDA is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear threat agents, and natural exposure(s) to pandemic influenza and emerging infectious diseases, including SARS-CoV-2 and the resulting COVID-19 disease. An outbreak of COVID-19 respiratory disease caused by a novel coronavirus was first detected in late 2019 and has since spread worldwide. The 2019 novel coronavirus, also known as Severe Acute Respiratory Disease Coronavirus-2 (SARS-CoV-2) has caused a significant number of deaths as well as substantial disease burden, both nationally and internationally. On January 31, 2020, HHS declared a Public Health Emergency for the United States to aid the nation’s healthcare community in responding to COVID-19. Starting with BARDA’s earliest COVID-19-related awards in February 2020, the BARDA COVID-19 medical countermeasure portfolio has quickly grown as new partnerships and products have been added to respond to the pandemic. The subject of this Sources Sought is current clinical stage development programs of one or more next-generation COVID-19 vaccines. Description: BARDA is issuing this RFI to assist in understanding the advanced developmental landscape of next-generation COVID-19 vaccines. BARDA is particularly interested in novel vaccine candidates with a development plan, clinical data, and demonstrated cGMP manufacturing level/capability to allow submission of an EUA and/or BLA by December 2022. Commercial scale manufacturing of product should be available in that same time frame. Vaccines that have the above attributes, improve efficacy, durability and/or coverage against potential variants, and have planned manufacturing capability of 50-100M doses/month are of particular interest. Respondents are asked to provide the following information: High level integrated development plan to regulatory approval, including use of the product as a primary vaccine or a boost Clinical stage of development - if product has entered clinical trials, summary data on safety, immunogenicity, and/or efficacy Clinical immunogenicity data - data to indicate durability, mucosal immunity, correlates of protection, and prevention of transmission Indication if the developer is willing to provide samples to USG for testing in centralized assays Description of the clinical operations (number of doses, route of administration, route of delivery) Breadth of protection (clinical or nonclinical data): Data on neutralization against variants of concern Data on T cell responses that may improve breadth Information on manufacturing status and potential capability Current scale of manufacturing (including all in process and release tests) and validation status Manufacturing scale up timelines and planned scale, including how much capacity has already been reserved At full scale, expected doses/month Planned final container presentation (single v. multidose) - for multidose vials and plans for inclusion (or not) of preservative Estimated per dose cost Any FDA feedback on the planned clinical development and/or manufacturing approach Information on the storage/stability data of the product Responses should be limited to 10 pages (or less) and shall be sent electronically to
[email protected]. Responses are due no later than February 2, 2022 by 3PM US EDT. THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY. Please note that contractors performing advisory and assistance services that support BARDA will have access to any submission under this RFI. Please do not include proprietary information in response to this RFI. HHS BARDA POC: Daniel Wolfe (
[email protected]; (202) 205-8968) and Jonathan Seals (
[email protected]; (202) 260-1010). Closing Date: February 2, 2022