HHS awards $10M contract for EV-D68 vaccine development, aiming for Phase I clinical trial

Contract Overview

Contract Amount: $10,006,906 ($10.0M)

Contractor: Intravacc B.V.

Awarding Agency: Department of Health and Human Services

Start Date: 2020-09-01

End Date: 2026-05-31

Contract Duration: 2,098 days

Daily Burn Rate: $4.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST NO FEE

Sector: R&D

Official Description: TO DEVELOP AN INTRAMUSCULAR INACTIVATED WHOLE VIRUS VACCINE FROM EARLY PRODUCT SELECTION THROUGH A PHASE I CLINICAL TRIAL TO INDUCE PROTECTION AGAINST EV D68 INDUCED AFM.

Plain-Language Summary

Department of Health and Human Services obligated $10.0 million to INTRAVACC B.V. for work described as: TO DEVELOP AN INTRAMUSCULAR INACTIVATED WHOLE VIRUS VACCINE FROM EARLY PRODUCT SELECTION THROUGH A PHASE I CLINICAL TRIAL TO INDUCE PROTECTION AGAINST EV D68 INDUCED AFM. Key points: 1. Contract focuses on developing an intramuscular inactivated whole virus vaccine for EV-D68. 2. The project spans from early product selection to a Phase I clinical trial. 3. This award represents a significant investment in addressing a serious neurological condition. 4. The chosen contract type (Cost No Fee) suggests a focus on research and development where final costs may be uncertain. 5. The duration of the contract (over 5 years) indicates a long-term commitment to vaccine development. 6. The specific NAICS code (541715) points to research and development in life sciences.

Value Assessment

Rating: good

The contract value of approximately $10 million for a multi-year vaccine development project, including a Phase I clinical trial, appears reasonable given the scope and complexity. Benchmarking against similar R&D contracts for vaccine development would provide a more precise assessment, but the cost aligns with the typical investment required for early-stage pharmaceutical research. The 'Cost No Fee' contract type indicates that the government will reimburse allowable costs, with no additional profit margin for the contractor, which can be cost-effective for the government in high-risk R&D scenarios.

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 bidders had the opportunity to submit proposals. This competitive process is expected to drive innovation and ensure fair pricing. The number of bidders is not specified, but the 'full and open' designation suggests a robust competition that should lead to a strong value proposition for the government.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can lead to lower prices and higher quality research outcomes.

Public Impact

The primary beneficiaries are individuals at risk of Enterovirus D68 (EV-D68) infection, particularly children who are more susceptible to its severe neurological complications like Acute Flaccid Myelitis (AFM). The contract will deliver a developed intramuscular inactivated whole virus vaccine candidate. The services delivered include research, development, and progression through a Phase I clinical trial. The geographic impact is national, focusing on public health within the United States, with potential global implications if the vaccine proves effective. Workforce implications include employment for scientists, researchers, clinical trial staff, and support personnel within the contractor's organization and potentially at clinical trial sites.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The long duration of the contract (over 5 years) could lead to cost overruns if research milestones are not met efficiently.
The 'Cost No Fee' contract type, while potentially cost-effective, requires diligent oversight to ensure that costs are reasonable and allowable.
The success of vaccine development is inherently uncertain, posing a risk that the full contract value may not result in a viable vaccine.
Reliance on a single contractor for this critical vaccine development phase could pose a risk if the contractor faces unforeseen challenges.

Positive Signals

Awarded under full and open competition, suggesting a competitive process that should yield good value.
The contract is for a critical public health need, addressing a serious neurological condition (AFM) caused by EV-D68.
The contractor, INTRAVACC B.V., is likely selected based on specialized expertise in vaccine development.
The project progresses through a Phase I clinical trial, indicating a structured and phased approach to development.

Sector Analysis

This contract falls within the Biotechnology and Pharmaceutical Research and Development sector, a critical area for public health innovation. The market for vaccine development is highly specialized, involving significant R&D investment and stringent regulatory pathways. Spending in this sector is driven by the need to address emerging infectious diseases and improve existing medical countermeasures. Comparable spending benchmarks would typically involve looking at other government-funded vaccine development programs or large pharmaceutical company R&D budgets for similar therapeutic areas.

Small Business Impact

The contract does not indicate any specific small business set-aside provisions. Given the specialized nature of vaccine development and the likely size and expertise required of the contractor (INTRAVACC B.V.), it is probable that this contract was not specifically targeted towards small businesses. There is no information provided regarding subcontracting plans, so the impact on the small business ecosystem is currently unknown but likely minimal for this specific award.

Oversight & Accountability

Oversight for this contract will likely be managed by the contracting officer and program officials within the National Institutes of Health (NIH), a component of HHS. Accountability measures are built into the contract through defined milestones and reporting requirements associated with the research and development phases. Transparency is facilitated by the public nature of federal contract awards, though specific details of the research progress may be proprietary. Inspector General jurisdiction would apply to any allegations of fraud, waste, or abuse related to the contract.

Related Government Programs

National Institute of Allergy and Infectious Diseases (NIAID) vaccine research programs
Centers for Disease Control and Prevention (CDC) infectious disease surveillance
Biomedical Advanced Research and Development Authority (BARDA) medical countermeasures
Department of Defense vaccine research initiatives

Risk Flags

Potential for research delays
Uncertainty of vaccine efficacy
Clinical trial risks
Long-term development timeline

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $10.0 million to INTRAVACC B.V.. TO DEVELOP AN INTRAMUSCULAR INACTIVATED WHOLE VIRUS VACCINE FROM EARLY PRODUCT SELECTION THROUGH A PHASE I CLINICAL TRIAL TO INDUCE PROTECTION AGAINST EV D68 INDUCED AFM.

Who is the contractor on this award?

The obligated recipient is INTRAVACC B.V..

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 $10.0 million.

What is the period of performance?

Start: 2020-09-01. End: 2026-05-31.

What is the track record of INTRAVACC B.V. in developing vaccines, particularly for viral diseases?

INTRAVACC B.V. is a spin-off from the Dutch Vaccine Institute (part of the Netherlands Vaccine Institute). They specialize in the development and manufacturing of vaccines. Their expertise includes developing inactivated virus vaccines, which aligns with the contract's objective. While specific details on their past successes and failures in bringing vaccines to market are not readily available in the public domain for this analysis, their establishment as a dedicated vaccine development entity suggests a focused capability. Further investigation into their pipeline, previous collaborations, and regulatory submissions would be necessary for a comprehensive assessment of their track record.

How does the $10 million award compare to typical Phase I clinical trial costs for vaccine development?

The total contract value of approximately $10 million covers the entire scope from early product selection through a Phase I clinical trial. Phase I trials themselves can vary significantly in cost, typically ranging from a few hundred thousand to several million dollars, depending on the complexity, duration, number of participants, and specific endpoints. Given that this $10 million also includes the preceding R&D phases (product selection, development), it appears to be a reasonable allocation. However, a precise comparison requires detailed cost breakdowns for each phase and benchmarking against similar government-funded vaccine development programs, which are not provided here.

What are the primary risks associated with developing an EV-D68 vaccine, and how are they mitigated by this contract?

The primary risks in developing an EV-D68 vaccine include the inherent scientific challenges of creating an effective and safe vaccine, the potential for the virus to mutate, and the complexities of clinical trials. EV-D68's association with Acute Flaccid Myelitis (AFM) adds a layer of complexity and urgency. This contract mitigates some risks by funding the R&D process and progressing to a Phase I trial, which is designed to assess safety and initial immunogenicity. The 'Cost No Fee' contract type, while requiring oversight, allows flexibility for research adjustments. However, the fundamental scientific and clinical risks remain significant and are inherent to vaccine development.

What is the historical spending by HHS on EV-D68 research or vaccine development prior to this award?

Historical spending data specifically on EV-D68 vaccine development by HHS prior to this award is not directly available within the provided contract details. However, HHS, through agencies like the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), has been involved in research related to enteroviruses, including EV-D68, and their neurological complications like AFM. This contract represents a specific, funded initiative to advance a vaccine candidate. To ascertain broader historical spending, a review of NIH and CDC research grants and contracts related to EV-D68 and AFM over previous fiscal years would be necessary.

What are the performance metrics or key performance indicators (KPIs) for this contract?

Specific performance metrics or Key Performance Indicators (KPIs) for this contract are not detailed in the provided summary data. However, typical KPIs for such a research and development contract would include achieving specific scientific milestones (e.g., successful antigen identification, formulation development), progression through preclinical testing, successful initiation and completion of Phase I clinical trial objectives (e.g., safety assessments, immunogenicity endpoints), adherence to timelines, and effective budget management. The contracting officer's representative (COR) would monitor progress against these implicit or explicit performance expectations.

What is the potential impact of this vaccine development on public health preparedness for future outbreaks?

The successful development of an EV-D68 vaccine would significantly enhance public health preparedness by providing a critical tool to prevent or mitigate the severity of infections, particularly the debilitating AFM. EV-D68 is a recurring pathogen, and having a vaccine could reduce the burden on healthcare systems, prevent long-term disability in affected individuals, and lessen public anxiety during outbreaks. This project contributes to building a broader portfolio of medical countermeasures against emerging and re-emerging infectious threats, strengthening the nation's overall response capabilities.

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 › General Science and Technology R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: HHS-NIH-NIAID-BAA2020-1

Offers Received: 1

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: ANTONIE V LEEUWENHOEKLN 9, BILTHOVEN

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Foreign Owned, Not Designated a Small Business, Special Designations

Financial Breakdown

Contract Ceiling: $10,226,419

Exercised Options: $10,006,906

Current Obligation: $10,006,906

Actual Outlays: $7,500,401

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline