The Department of Health and Human Services, Office of the Secretary of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority has a requirement to provide advanced development, licensure, and procurement of vaccines against Marburg virus (MARV) and Sudan ebolavirus (SUDV).

This request for proposals (RFP) is for the advanced development, licensure, and procurement of monovalent vaccines against Marburg virus (MARV) and Sudan virus (SUDV) respectively. Furthermore, this RFP will also support late-stage development and Phase 4 Post-Marketing commitments/requirements required by the Food and Drug Administration (FDA) for products approved under the traditional, animal rule, or accelerated pathways. Filoviruses are known to cause severe health consequences, including death, in humans. Infections with Ebola virus (EBOV), Sudan virus (SUDV), and Marburg virus (MARV) can lead to case fatality rates of up to 90%. The West Africa outbreak of EBOV during 2014-2015 resulted in 28,646 confirmed, probable, and suspected cases, with 11,323 reported deaths. Several individuals were transported back to the US for treatment, and four confirmed cases were treated in the US, underscoring the urgent need for MCMs for filoviruses to be developed, manufactured, and procured to protect the US population. While there is a licensed vaccine against EBOV, there are currently no FDA-licensed vaccines or therapeutics for SUDV and MARV. The immediate need for MARV and SUDV vaccines has been emphasized by recent outbreaks, including the SUDV outbreak in 2022 that resulted in 141 confirmed cases and 55 deaths. Additionally, a MARV outbreak in 2024 led to 66 confirmed cases and 15 deaths. In 2006, the Department of Homeland Security (DHS) determined that Ebola viruses and MARV are material threats to national health security. The threat of filovirus agents being used as biological/bioterror weapons led the DHS to issue a Material Threat Determination (MTD) based on its Material Threat Assessment (MTA) for Ebola viruses and MARV. In July 2014, Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) issued the “Product-Specific Requirements for Medical Countermeasures for Marburg and Ebola Virus Diseases”. The document defines the product requirements for both post-exposure prophylaxis (PEP) and therapeutic treatment of infections caused by an intentional large-scale release of an Ebola virus or MARV. The resulting product(s) produced would be procured using Project BioShield (PBS) funds. In the event of a declared emergency prior to licensure of the vaccine by the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Review (CBER), it is anticipated that the investigational product(s) may be administered under an Emergency Use Authorization (EUA) held by the CDC or BARDA. The United States Government (USG) desires vaccines that can meet the PHEMCE product requirements for MCM against MARV and SUDV exposure. This RFP will also support the necessary late-stage development to achieve licensure of the product(s) being procured.

• The USG is seeking to support the advanced development and licensure of a monovalent MARV and a monovalent SUDV vaccine respectively. Additionally, USG is seeking to procure and maintain up to 500,000 licensed regimens of monovalent vaccines against MARV and SUDV respectively. Additionally, USG may procure up to 300,000 doses prelicensure of MARV and SUDV monovalent vaccines. The vaccines shall either be delivered to the Strategic National Stockpile (SNS) or maintained as vendor-managed inventory (VMI) storage through the end of the contract as determined by BARDA and the Contracting Officer. The regimen shall be provided as Final Drug Product (FDP). The USG is seeking vaccines held by the SNS or VMI storage that may be administered under an Emergency Use Authorization (EUA) if an emergency is declared in response to a future outbreak.
• The Contractor shall provide, as part of the Contract, a VMI storage program for the specified product in which the Contractor shall monitor and maintain, as specified in an inventory management plan, required inventory levels and product shelf-life. The Contractor shall provide availability of shipments 24 hours a day, 7 days a week, 365 days a year and shall be able to deploy as requested pursuant to the Contract. The VMI storage provided by the Contractor shall include a plan to provide the USG with an accurate inventory of the product as well as Contractor storage location(s) should the USG have an immediate need for the product to be released from VMI storage in an emergency situation. The Contractor’s plan to provide access to the product as needed by the USG and the Quality Agreement with the Administration for Strategic Preparedness and Response (ASPR) shall align with the USG’s specific product use during a mass casualty incident. In order to meet the above objectives, the Contractor shall have evidence that the labeling, storage, distribution and transport programs are secure and controlled.