HHS awards $95.6M contract for Marburg and Sudan Ebolavirus vaccine development

Contract Overview

Contract Amount: $95,592,504 ($95.6M)

Contractor: International Aids Vaccine Initiative Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2021-09-30

End Date: 2027-11-30

Contract Duration: 2,252 days

Daily Burn Rate: $42.4K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF MONOVALENT VACCINES FOR PREVENTION OF MARBURG VIRUS (MARV) AND SUDAN EBOLAVIRUS (SUDV) DISEASE. THESE VACCINES ARE BASED ON RECOMBINANT EXPRESSION OF FILOVIRUS GLYCOPROTEINS IN

Place of Performance

Location: NEW YORK, NEW YORK County, NEW YORK, 10004

State: New York Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $95.6 million to INTERNATIONAL AIDS VACCINE INITIATIVE INC. for work described as: THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF MONOVALENT VACCINES FOR PREVENTION OF MARBURG VIRUS (MARV) AND SUDAN EBOLAVIRUS (SUDV) DISEASE. THESE VACCINES ARE BASED ON RECOMBINANT EXPRESSION OF FILOVIRUS GLYCOPROTEINS IN Key points: 1. Focus on critical biodefense research for emerging infectious diseases. 2. Contract aims to accelerate vaccine development timelines. 3. Potential for significant public health impact in preventing outbreaks. 4. Long-term contract duration suggests sustained research effort. 5. Fixed-price structure provides cost certainty for the government. 6. Research and Development in Biotechnology sector.

Value Assessment

Rating: good

The contract value of $95.6 million over approximately six years for advanced vaccine research appears reasonable given the complexity and critical nature of developing countermeasures against high-consequence pathogens like Marburg and Sudan Ebolavirus. Benchmarking against similar R&D contracts for novel vaccine platforms, this investment aligns with the typical cost profiles for early-stage to mid-stage development of biodefense agents. The firm fixed-price structure helps manage cost overruns, although the ultimate success of the research is not guaranteed.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple qualified offerors had the opportunity to bid. The specific number of bidders is not provided, but the use of full and open competition generally fosters a competitive environment, encouraging fair pricing and innovation. This approach allows the government to select the most capable and cost-effective solution from a broad range of potential contractors.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it increases the likelihood of securing the best value by leveraging market forces to drive down costs and improve quality.

Public Impact

The primary beneficiaries are public health organizations and populations at risk of Marburg and Sudan Ebolavirus outbreaks. The contract will advance the development of monovalent vaccines for these specific diseases. Geographic impact is global, as these viruses pose international health security threats. Workforce implications include supporting specialized scientific and research personnel in the biotechnology sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long contract duration could lead to scope creep if not managed tightly.
Success is dependent on complex scientific breakthroughs, which are inherently uncertain.
Potential for reliance on a single contractor for critical vaccine development.

Positive Signals

Addresses a critical unmet need in biodefense preparedness.
Firm fixed-price contract provides budget predictability.
Full and open competition suggests a robust selection process.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a critical area for national security and public health. The market for vaccine development, particularly for emerging infectious diseases and biothreats, is characterized by high R&D costs, long development cycles, and significant regulatory hurdles. Government funding plays a crucial role in de-risking these investments. Comparable spending in biodefense R&D can range from tens to hundreds of millions of dollars for advanced development programs.

Small Business Impact

The provided data does not indicate any specific small business set-asides or subcontracting requirements for this contract. Given the specialized nature of advanced vaccine development, the prime contractor is likely a large entity with extensive research capabilities. Further analysis would be needed to determine if opportunities exist for small businesses within the supply chain or through subcontracting.

Oversight & Accountability

Oversight for this contract would typically reside within the Department of Health and Human Services, specifically the Office of the Assistant Secretary for Preparedness and Response (ASPR). ASPR is responsible for leading the nation in preparing for, responding to, and recovering from public health emergencies. Accountability measures would likely include regular progress reports, milestone achievements, and adherence to scientific and ethical standards. Transparency is generally maintained through contract awards databases and public health reporting.

Related Government Programs

Biodefense Advanced Research Projects Agency (BARDA) programs
National Institutes of Health (NIH) vaccine research
Centers for Disease Control and Prevention (CDC) infectious disease surveillance
Department of Defense (DoD) biosecurity initiatives

Risk Flags

Scientific uncertainty in vaccine development
Long development timelines
Potential for pathogen mutation or evolution
Manufacturing scale-up challenges

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $95.6 million to INTERNATIONAL AIDS VACCINE INITIATIVE INC.. THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF MONOVALENT VACCINES FOR PREVENTION OF MARBURG VIRUS (MARV) AND SUDAN EBOLAVIRUS (SUDV) DISEASE. THESE VACCINES ARE BASED ON RECOMBINANT EXPRESSION OF FILOVIRUS GLYCOPROTEINS IN

Who is the contractor on this award?

The obligated recipient is INTERNATIONAL AIDS VACCINE INITIATIVE INC..

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 $95.6 million.

What is the period of performance?

Start: 2021-09-30. End: 2027-11-30.

What is the track record of International AIDS Vaccine Initiative Inc. in developing vaccines for filoviruses?

International AIDS Vaccine Initiative (IAVI) is a non-profit research organization with a long history of developing vaccines, primarily focusing on HIV/AIDS. While their core expertise lies in HIV, they have also engaged in research for other infectious diseases. Information specific to their success in developing vaccines for filoviruses like Marburg and Sudan Ebolavirus would require a deeper dive into their project portfolio and published research. However, their established infrastructure and experience in vaccine development suggest a capacity to undertake such research, though specific filovirus vaccine success metrics are not immediately available from the contract data alone.

How does the $95.6 million contract value compare to similar federal investments in filovirus vaccine research?

The $95.6 million awarded to IAVI for Marburg and Sudan Ebolavirus vaccine development is a significant investment, but it aligns with the substantial funding required for advanced vaccine R&D, particularly for high-consequence pathogens. Federal agencies like BARDA and NIH have historically awarded contracts in the range of tens to hundreds of millions of dollars for vaccine candidates targeting emerging infectious diseases and biothreats. For instance, contracts for Ebola vaccine development during past outbreaks have also reached similar financial scales. The long duration (over 6 years) and firm fixed-price nature suggest a comprehensive, multi-stage development program, making direct comparisons challenging without knowing the specific development phase and scope.

What are the primary scientific and technical risks associated with this vaccine development contract?

The primary scientific and technical risks are inherent to vaccine development itself. These include the challenge of eliciting a robust and durable immune response against filovirus glycoproteins, potential safety concerns related to novel vaccine platforms, and the difficulty in predicting efficacy in humans based on preclinical models. Furthermore, the specific monovalent approach for both Marburg and Sudan Ebolavirus may face challenges in achieving broad protection or may require combination strategies. Manufacturing scale-up and stability of the final vaccine product also represent significant technical hurdles that could impact the project's success.

What is the expected timeline for achieving key milestones under this contract?

While the contract end date is November 30, 2027, specific key milestones are not detailed in the provided data. Typically, vaccine development contracts of this nature involve phased milestones such as completion of preclinical studies (in vitro and in vivo), initiation and completion of Phase 1 human safety trials, potential progression to Phase 2 efficacy studies, and development of manufacturing processes. Given the contract duration of over six years, it is reasonable to infer that the project encompasses multiple stages, likely including significant preclinical work and early-phase human trials, with the ultimate goal of advancing candidates towards later-stage development or licensure.

What historical spending patterns exist within HHS for filovirus countermeasures?

The Department of Health and Human Services (HHS), particularly through agencies like the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH), has a history of investing in filovirus countermeasures, including vaccines and therapeutics. Spending in this area has often been driven by specific public health needs, such as responses to Ebola outbreaks in West Africa and the Democratic Republic of Congo. Historical funding has supported a range of activities from basic research to late-stage clinical trials and manufacturing preparedness. The total federal investment in filovirus countermeasures over the past decade likely amounts to several hundred million dollars, reflecting the perceived threat and the long development timelines.

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

Solicitation ID: BAA18100SOL00003

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 125 BROAD ST FL 9TH, NEW YORK, NY, 10004

Business Categories: Category Business, Corporate Entity Tax Exempt, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $166,898,763

Exercised Options: $95,592,504

Current Obligation: $95,592,504

Actual Outlays: $41,900,563

Subaward Activity

Number of Subawards: 37

Total Subaward Amount: $25,656,434

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline