HHS awards $19.5M for OSIVAX influenza vaccine R&D, aiming for pandemic protection

Contract Overview

Contract Amount: $19,485,392 ($19.5M)

Contractor: Osivax

Awarding Agency: Department of Health and Human Services

Start Date: 2025-07-25

End Date: 2028-07-24

Contract Duration: 1,095 days

Daily Burn Rate: $17.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST SHARING

Sector: R&D

Official Description: OSIVAX - CLINICAL PROOF OF CONCEPT OF OVX836, A SINGLE-SHOT BROADLY PROTECTIVE INFLUENZA A VACCINE FOR IMMEDIATE PROTECTION AGAINST EMERGING PANDEMIC STRAINS

Plain-Language Summary

Department of Health and Human Services obligated $19.5 million to OSIVAX for work described as: OSIVAX - CLINICAL PROOF OF CONCEPT OF OVX836, A SINGLE-SHOT BROADLY PROTECTIVE INFLUENZA A VACCINE FOR IMMEDIATE PROTECTION AGAINST EMERGING PANDEMIC STRAINS Key points: 1. The contract focuses on a novel, single-shot influenza A vaccine (OVX836) designed for broad protection against pandemic strains. 2. OSIVAX is the sole contractor, indicating a specialized capability or a unique stage in development. 3. The primary risk lies in the inherent uncertainty of R&D, particularly vaccine development, with potential for delays or failure to meet efficacy targets. 4. Spending falls within the Research and Development in Biotechnology sector, a critical area for public health preparedness.

Value Assessment

Rating: questionable

The $19.5 million award for a clinical proof of concept is substantial for early-stage R&D. Benchmarking is difficult without more specific contract details on milestones and deliverables, but it appears to be a significant investment for a single-shot vaccine's development phase.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting multiple entities could have bid. However, OSIVAX is listed as the sole contractor, implying they were selected as the most qualified or best-suited for this specific R&D project.

Taxpayer Impact: Taxpayer funds are being invested in critical pandemic preparedness research, potentially yielding significant long-term public health benefits if successful, but with inherent R&D risks.

Public Impact

Development of a broadly protective influenza vaccine could significantly reduce the impact of future pandemics. The single-shot nature of the vaccine offers potential logistical advantages for rapid deployment. Investment in domestic vaccine R&D enhances national biosecurity and public health infrastructure.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

R&D inherent risks
Sole contractor for specialized development

Positive Signals

Addresses critical pandemic preparedness need
Potential for broad-spectrum protection
Single-shot administration

Sector Analysis

This contract falls under Research and Development in Biotechnology, specifically focusing on vaccine development. Spending benchmarks for early-stage clinical proof of concept for novel vaccines can vary widely, but $19.5 million represents a significant investment in a high-risk, high-reward area.

Small Business Impact

The contract does not indicate any specific provisions or set-asides for small businesses. The focus on specialized biotechnology R&D may naturally favor larger, established firms or those with specific intellectual property.

Oversight & Accountability

The Department of Health and Human Services, through the Office of Assistant Secretary for Preparedness and Response, is overseeing this R&D contract. Standard oversight mechanisms for federal contracts, including milestone tracking and performance reviews, would apply.

Related Government Programs

Research and Development in Biotechnology (except Nanobiotechnology)
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Technological risk associated with novel vaccine development
Uncertainty of achieving broad protection against diverse influenza strains
Potential for delays in clinical trials and regulatory approval
Dependence on a single contractor for critical R&D

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $19.5 million to OSIVAX. OSIVAX - CLINICAL PROOF OF CONCEPT OF OVX836, A SINGLE-SHOT BROADLY PROTECTIVE INFLUENZA A VACCINE FOR IMMEDIATE PROTECTION AGAINST EMERGING PANDEMIC STRAINS

Who is the contractor on this award?

The obligated recipient is OSIVAX.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $19.5 million.

What is the period of performance?

Start: 2025-07-25. End: 2028-07-24.

What are the specific clinical endpoints and success criteria for the proof of concept phase, and how will they be measured?

The specific clinical endpoints and success criteria are not detailed in the provided data. Typically, for a vaccine proof of concept, these would include demonstrating immunogenicity (e.g., antibody production, T-cell responses) in target populations, assessing safety and tolerability, and potentially preliminary evidence of efficacy against specific influenza strains or challenge models. Measurement would involve rigorous clinical trial protocols, laboratory analysis of biological samples, and adverse event monitoring.

What is the likelihood of OSIVAX's OVX836 vaccine achieving broad protection against emerging pandemic strains, given the historical challenges in influenza vaccine development?

The likelihood is inherently uncertain, as influenza virus evolution poses significant challenges. While OVX836's 'broadly protective' claim is promising, historical attempts at universal or broadly protective vaccines have faced hurdles. Success depends on the vaccine's mechanism of action targeting conserved viral components and its ability to elicit durable, cross-protective immune responses. Clinical trial data will be crucial to validate these claims.

How does the $19.5 million investment compare to typical funding for similar early-stage vaccine R&D projects, and what is the expected return on investment for taxpayers?

The $19.5 million for a clinical proof of concept is a substantial, but not necessarily atypical, investment for novel vaccine R&D, especially for pandemic preparedness. The return on investment for taxpayers is primarily measured in public health security – preventing widespread illness, death, and economic disruption from a pandemic. If successful, the societal benefit could far outweigh the initial investment, though the financial return is indirect.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 1

Pricing Type: COST SHARING (T)

Evaluated Preference: NONE

Contractor Details

Address: 4 RUE DE COPENHAGUE, PARIS 8

Business Categories: Category Business, Foreign Owned, International Organization, Not Designated a Small Business, Special Designations

Financial Breakdown

Contract Ceiling: $98,593,151

Exercised Options: $19,485,392

Current Obligation: $19,485,392

Actual Outlays: $685,710

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline