Preparing for the Next Biological Threat: BARDA’s Vaccine Initiative for MARV and SUDV
The Biomedical Advanced Research and Development Authority (BARDA), operating under the U.S. Department of Health and Human Services (HHS), has issued a pre-solicitation notice signaling its intent to launch a major Request for Proposal (RFP) later this year. This effort, managed by the Administration for Strategic Preparedness and Response (ASPR), seeks to advance the development, licensure, and procurement of urgently needed vaccines for Marburg virus (MARV) and Sudan ebolavirus (SUDV). With a long-standing recognition of these filoviruses as material threats to national health security, BARDA’s initiative is a decisive step toward closing a dangerous medical countermeasure gap.
The overarching goal of this future RFP is to establish a pipeline of FDA-licensed vaccines to protect the U.S. population against MARV and SUDV, both of which have caused deadly outbreaks in recent years. While a vaccine exists for Ebola virus (ERVEBO), it is not approved for use against its Sudanese counterpart or Marburg virus, which carry similarly high case fatality rates. The planned initiative reflects a proactive, threat-informed approach to biological preparedness, leveraging both late-stage development and FDA-required post-marketing activities to ensure long-term vaccine availability and stockpiling.
The Solicitation at a Glance: Scope and Objectives
BARDA’s forthcoming RFP will support the late-stage development and licensure of MARV and SUDV vaccines, including fulfillment of FDA post-marketing requirements under the Animal Rule, an approval pathway used when human efficacy studies are not ethical or feasible. The contract is also expected to encompass procurement of licensed vaccines to build national stockpiles.
This effort is rooted in a broader assessment from the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which identified the need for 2.9 million post-exposure prophylaxis doses for MARV and 1.13 million for ebolaviruses. The absence of any FDA-approved vaccines for MARV and SUDV, despite recent outbreaks in 2022 and 2024 respectively, has elevated the urgency for a coordinated and fully resourced development initiative.
Key Dates to Watch
While this is not yet a formal Request for Proposal, the pre-solicitation outlines a projected timeline and critical steps:
- RFP Release (Anticipated): Mid-to-late 2025
- Award Date: On or around September 2025
- Contract Structure: Will include both cost-plus-fixed-fee and firm-fixed-price line items
- Period of Performance: Up to 120 months (10 years), with a 60-month base period
Prospective applicants must ensure active registration in the System for Award Management (SAM.gov) before proposal submission.
Funding and Award Details
Although precise funding levels will be clarified in the RFP, BARDA anticipates awarding one or more contracts to support the development and acquisition of MARV and SUDV vaccines. The long performance period reflects the need for comprehensive development timelines, phased FDA engagement, and eventual procurement. BARDA is expected to fund both advanced development and procurement components, suggesting significant financial support for selected awardees.
Why This Work Matters
With fatality rates approaching 90%, and recent MARV and SUDV outbreaks reaffirming their pandemic potential, the absence of licensed vaccines for these threats is a glaring vulnerability in the U.S. biodefense strategy. BARDA’s forthcoming RFP addresses this head-on, aiming to deliver safe, effective, and licensable vaccines that can be rapidly deployed in the event of an outbreak—whether naturally occurring or as a result of bioterrorism.
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