NIH awards $11.5M contract to Eveliqure Biotechnologies for Shigetec vaccine development and clinical trials

Contract Overview

Contract Amount: $11,480,630 ($11.5M)

Contractor: Eveliqure Biotechnologies Gmbh

Awarding Agency: Department of Health and Human Services

Start Date: 2020-09-01

End Date: 2027-03-31

Contract Duration: 2,402 days

Daily Burn Rate: $4.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 4

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: TO ADVANCE THE DEVELOPMENT OF THE SHIGETEC VACCINE THROUGH CGMP MANUFACTURING AND RELEASE OF ADDITIONAL CGMP LOTS FOR USE IN A SERIES OF PHASE 2 CLINICAL TRIALS.

Plain-Language Summary

Department of Health and Human Services obligated $11.5 million to EVELIQURE BIOTECHNOLOGIES GMBH for work described as: TO ADVANCE THE DEVELOPMENT OF THE SHIGETEC VACCINE THROUGH CGMP MANUFACTURING AND RELEASE OF ADDITIONAL CGMP LOTS FOR USE IN A SERIES OF PHASE 2 CLINICAL TRIALS. Key points: 1. Contract supports critical Phase 2 clinical trials for the Shigetec vaccine. 2. Focus on CGMP manufacturing ensures quality and readiness for human trials. 3. Long-term contract duration suggests a sustained need for vaccine development. 4. The chosen contract type (Cost Plus Fixed Fee) allows for flexibility in R&D. 5. This award represents a significant investment in vaccine research and public health preparedness.

Value Assessment

Rating: good

The contract value of $11.5 million over approximately 6.5 years for vaccine development and manufacturing appears reasonable given the scope. While direct comparisons are difficult without specific details on the Shigetec vaccine's stage of development and the complexity of CGMP manufacturing required, the cost aligns with typical R&D investments in novel therapeutics. The Cost Plus Fixed Fee structure is common for research where final costs can be uncertain, but it necessitates careful oversight to manage expenses effectively.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple qualified vendors had the opportunity to bid. The presence of 4 bidders (as indicated by 'no': 4) suggests a competitive environment, which generally leads to better pricing and innovation. This level of competition is a positive sign for the government's ability to secure a capable contractor at a fair price.

Taxpayer Impact: Full and open competition ensures that taxpayer dollars are used efficiently by fostering a marketplace where contractors vie for the best value, potentially leading to cost savings and higher quality outcomes.

Public Impact

The primary beneficiaries are patients who may eventually receive the Shigetec vaccine, contributing to public health. The contract delivers essential CGMP manufacturing services and supports the progression of Phase 2 clinical trials. The geographic impact is primarily within the United States, where the research and manufacturing activities will likely take place. This contract supports specialized jobs in biotechnology, pharmaceutical manufacturing, and clinical research.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns inherent in Cost Plus Fixed Fee contracts if not closely monitored.
Reliance on a single contractor for a critical phase of vaccine development could pose a risk if performance issues arise.

Positive Signals

Awarded through full and open competition, suggesting a robust selection process.
Contract duration of over 2000 days indicates a long-term commitment and potential for successful project completion.
Focus on CGMP manufacturing aligns with stringent quality standards for pharmaceutical products.

Sector Analysis

This contract falls within the Biotechnology and Pharmaceutical R&D sector, a rapidly growing area driven by advancements in life sciences and a continuous need for new vaccines and therapeutics. The market is characterized by high innovation, significant investment, and stringent regulatory requirements. Comparable spending in this sector often involves substantial R&D budgets for drug discovery, clinical trials, and manufacturing scale-up, with contracts ranging from millions to billions of dollars depending on the therapeutic area and development stage.

Small Business Impact

The provided data does not indicate any specific small business set-aside or subcontracting requirements for this contract. As a full and open competition award, it is possible that small businesses could have participated as prime contractors or subcontractors if they met the qualifications. Further analysis would be needed to determine the extent of small business involvement.

Oversight & Accountability

Oversight for this contract will likely be managed by the National Institutes of Health (NIH), a component of the Department of Health and Human Services. Mechanisms would include regular progress reports, financial reviews, and adherence to CGMP standards. The Cost Plus Fixed Fee structure necessitates diligent monitoring of expenditures against the fixed fee and allowable costs to ensure value for money. Transparency is generally maintained through contract awards databases and public reporting of clinical trial progress.

Related Government Programs

Vaccine Development Programs
Biotechnology Research Grants
Clinical Trial Support Services
CGMP Manufacturing Contracts
National Institutes of Health Research Initiatives

Risk Flags

Cost Plus Fixed Fee contract requires diligent oversight to manage potential cost overruns.
Long contract duration necessitates sustained monitoring of performance and progress.
Dependence on a single contractor for critical manufacturing and trial support.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $11.5 million to EVELIQURE BIOTECHNOLOGIES GMBH. TO ADVANCE THE DEVELOPMENT OF THE SHIGETEC VACCINE THROUGH CGMP MANUFACTURING AND RELEASE OF ADDITIONAL CGMP LOTS FOR USE IN A SERIES OF PHASE 2 CLINICAL TRIALS.

Who is the contractor on this award?

The obligated recipient is EVELIQURE BIOTECHNOLOGIES GMBH.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $11.5 million.

What is the period of performance?

Start: 2020-09-01. End: 2027-03-31.

What is the specific nature of the Shigetec vaccine and its intended therapeutic use?

The provided data indicates that the Shigetec vaccine is intended for development through CGMP manufacturing and subsequent use in Phase 2 clinical trials. However, the specific disease or condition the Shigetec vaccine targets is not detailed in the provided information. Further research into NIH's vaccine development pipeline or specific press releases from Eveliqure Biotechnologies would be necessary to ascertain the exact therapeutic application. Vaccine development is a complex process, and Phase 2 trials are crucial for evaluating efficacy and safety in a larger patient group than Phase 1.

How does the $11.5 million contract value compare to typical R&D costs for vaccine development and CGMP manufacturing?

The $11.5 million contract value for vaccine development and CGMP manufacturing over approximately 6.5 years is within the expected range for such specialized work. Developing a vaccine from early research through Phase 2 clinical trials and establishing CGMP manufacturing capabilities can be extremely costly. Costs are driven by extensive research, complex biological processes, rigorous quality control, specialized facilities, and the clinical trial process itself, which involves patient recruitment, monitoring, and data analysis. While specific benchmarks vary widely based on the vaccine type (e.g., mRNA, viral vector, subunit) and the scale of manufacturing required, this award appears to be a significant but not unusually high investment for advancing a vaccine candidate to this stage.

What are the potential risks associated with a Cost Plus Fixed Fee (CPFF) contract for vaccine R&D?

Cost Plus Fixed Fee contracts, while offering flexibility for R&D projects with uncertain outcomes, carry inherent risks. For the government, the primary risk is that the contractor may have less incentive to control costs compared to a fixed-price contract, as costs are reimbursed plus a fixed fee. This can lead to potential cost overruns if not managed diligently. The government must implement robust oversight mechanisms to scrutinize allowable costs and ensure the contractor is operating efficiently. For the contractor, the fixed fee may not adequately compensate for unforeseen complexities or extended timelines, potentially impacting profitability if not accurately estimated. Effective communication and transparent reporting are crucial to mitigate these risks.

What is Eveliqure Biotechnologies' track record in vaccine development and CGMP manufacturing?

Information regarding Eveliqure Biotechnologies' specific track record in vaccine development and CGMP manufacturing is not detailed in the provided contract data. To assess their capabilities, one would need to review their company history, previous contracts (especially with government agencies like NIH), published research, regulatory filings (e.g., FDA approvals or submissions), and any available performance reviews. A strong track record in similar projects, adherence to regulatory standards, and successful completion of prior development phases would indicate a lower risk for this contract. Without this external information, the assessment relies solely on the competitive award process.

How does this contract fit into the broader NIH strategy for infectious disease research or vaccine preparedness?

This contract directly supports the National Institutes of Health's (NIH) mission to advance fundamental knowledge about diseases and find ways to combat them. By funding the development and manufacturing of the Shigetec vaccine through CGMP standards for Phase 2 trials, NIH is investing in potential solutions for public health challenges. This aligns with broader strategies for infectious disease research, pandemic preparedness, and the development of novel therapeutics. NIH often supports promising vaccine candidates through various stages of development, recognizing the critical role of such investments in safeguarding public health and responding to emerging threats.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

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: HHS-NIH-NIAID-2019-1

Offers Received: 4

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: KARL-FARKAS-GASSE 22, WIEN

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

Financial Breakdown

Contract Ceiling: $25,619,524

Exercised Options: $11,480,630

Current Obligation: $11,480,630

Actual Outlays: $6,437,575

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline