Marburg virus (MARV) and Sudan virus (SUDV) Vaccines 75A50125R00006

Synopsis This pre-solicitation notice serves as the intent to announce a Request for Proposal (RFP) at a later date for the advanced development, licensure, and procurement of vaccines against Marburg virus (MARV) and Sudan ebolavirus (SUDV). Furthermore, the intended 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 animal rule. The Filovirus family, which includes Marburg virus (MARV) and the ebolaviruses Ebola virus (EBOV) and Sudan virus (SUDV), are known to cause severe health consequences, including death, in humans. Infections with EBOV, SUDV, and MARV can lead to case fatality rates of up to 90%. The West Africa outbreak of EBOV during 2014-2016 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 medical countermeasures (MCMs) for filoviruses to be developed, manufactured, and stockpiled 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 virus 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 virus and MARV. Based on an assessment by DHS and medical consequence monitoring by the Department of Health and Human Services (HHS), the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) determined in 2014 that 1,130,000 doses of post exposure prophylaxis would be needed for ebolavirus vaccines. Additionally, 2,900,000 doses of post exposure prophylaxis would be needed for Marburg virus vaccines. While we do have a licensed vaccine, ERVEBO, for the prevention of EBOV, this vaccine is not indicated for use in SUDV or MARV. Therefore, there is an ongoing need for the development, licensure, and acquisition of vaccines for both MARV and SUDV. Pre-Solicitation Notice Objective This Pre-solicitation Notice is issued pursuant to FAR Subpart 5.2. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Pre-solicitation Notice does not commit the Government to contract for any supply or service whatsoever. Updates to the details provided could arise based on information and insight gained in the interim. Furthermore, BARDA is not at this time seeking proposals, and will not accept unsolicited proposals. Any contract(s) awarded from the RFP solicitation will have both cost-plus-fixed-fee and firm-fixed- price line items and will be awarded in or around September 2025. The anticipated period of performance for any resultant contract(s) will be up to 120 months with an initial base period of 60 months. Additional details and requirements will be described in the solicitation. Furthermore, all respondents must be registered in the System for Award Management (SAM): https://www.sam.gov.

The 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies Ebola virus and Marburg virus as high-priority threats as determined by the Department of Homeland Security to present a material threat to national security. Strategies to mitigate the threat of Ebola virus and Marburg virus include the development of vaccines suitable for protection against Ebola and Marburg virus disease respectively. BARDA is seeking vaccines that can be safely and effectively used for the U.S. civilian population in individuals with an elevated risk of exposure to Sudan virus (SUDV) and Marburg virus (MARV). This acquisition will allow BARDA to invest Project BioShield funds for the advanced development, US Food and Drug Administration (FDA) licensure, procurement, shipping, and vendor managed inventory (VMI) storage of MARV and SUDV monovalent vaccines.

The 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies Ebola virus and Marburg virus as high-priority threats as determined by the Department of Homeland Security to present a material threat to national security. Strategies to mitigate the threat of Ebola virus and Marburg virus include the development of vaccines suitable for protection against Ebola and Marburg virus disease respectively. BARDA is seeking vaccines that can be safely and effectively used for the U.S. civilian population in individuals with an elevated risk of exposure to Sudan virus (SUDV) and Marburg virus (MARV). This acquisition will allow BARDA to invest Project BioShield funds for the advanced development, US Food and Drug Administration (FDA) licensure, procurement, shipping, and vendor managed inventory (VMI) storage of MARV and SUDV monovalent vaccines.