HHS awards $11.26M for synthetic vaccine development, with research extending through August 2026

Contract Overview

Contract Amount: $11,260,157 ($11.3M)

Contractor: Access to Advanced Health Institute

Awarding Agency: Department of Health and Human Services

Start Date: 2018-09-21

End Date: 2026-08-31

Contract Duration: 2,901 days

Daily Burn Rate: $3.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 24

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF:OT::IGF - ADVANCED DEVELOPMENT AND CLINICAL EVALUATION OF A SYNTHETIC INTRANASAL ENTAMOEBA HISTOLYTICA VACCINE CONTAINING ADJUVANT.

Place of Performance

Location: SEATTLE, KING County, WASHINGTON, 98102

State: Washington Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $11.3 million to ACCESS TO ADVANCED HEALTH INSTITUTE for work described as: IGF:OT::IGF - ADVANCED DEVELOPMENT AND CLINICAL EVALUATION OF A SYNTHETIC INTRANASAL ENTAMOEBA HISTOLYTICA VACCINE CONTAINING ADJUVANT. Key points: 1. Contract focuses on advanced development and clinical evaluation of a novel vaccine. 2. Research and Development in Biotechnology sector, specifically vaccine development. 3. Contract type is Cost Plus Fixed Fee, indicating potential for cost overruns. 4. Full and open competition suggests a competitive bidding process. 5. Contract duration is substantial, spanning nearly 8 years. 6. Performance is in Washington, D.C.

Value Assessment

Rating: fair

The contract value of $11.26 million for advanced vaccine development appears reasonable given the scope and duration. However, without specific benchmarks for similar synthetic intranasal vaccine development contracts, a precise value-for-money assessment is challenging. The Cost Plus Fixed Fee (CPFF) structure means the government pays allowable costs plus a fixed fee, which can lead to higher final costs if initial estimates are low. Benchmarking against other NIH-funded R&D contracts in biotechnology would provide a clearer picture of pricing efficiency.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that all responsible sources were permitted to submit a bid. The data does not specify the number of bidders, but this procurement method generally fosters a competitive environment, which can lead to better pricing and innovation. The agency sought proposals from a wide range of potential contractors, suggesting a deliberate effort to explore the market.

Taxpayer Impact: Full and open competition is generally favorable for taxpayers as it increases the likelihood of obtaining the best value through a robust bidding process.

Public Impact

The primary beneficiaries are public health, through the potential development of a new vaccine against Entamoeba histolytica. Services delivered include advanced development and clinical evaluation of a synthetic intranasal vaccine. Geographic impact is national, with potential global health benefits. Workforce implications include employment for researchers, scientists, and clinical staff involved in vaccine development.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee (CPFF) contract type can lead to costs exceeding initial estimates.
Long contract duration (nearly 8 years) increases exposure to potential scope creep or changing research needs.
Specific details on the number of bidders are not provided, limiting a full assessment of competitive intensity.

Positive Signals

Awarded under full and open competition, suggesting a broad search for qualified contractors.
Focus on a critical public health need (vaccine development).
Contractor is Access to Advanced Health Institute, suggesting specialized expertise.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, a rapidly evolving field focused on leveraging biological processes for innovation. The market for vaccine development is substantial, driven by ongoing public health threats and advancements in scientific understanding. This specific contract addresses a niche but important area of infectious disease research. Comparable spending benchmarks would typically be found within NIH's broader portfolio of biomedical research grants and contracts.

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, it is possible that the primary contractor is a larger entity or a research institute. Further analysis would be needed to determine if small businesses are involved in subcontracting opportunities.

Oversight & Accountability

Oversight for this contract would primarily fall under the National Institutes of Health (NIH), a component of the Department of Health and Human Services (HHS). NIH has established procedures for monitoring research and development contracts, including regular progress reports, financial reviews, and adherence to scientific protocols. The Inspector General of HHS also has jurisdiction to investigate potential fraud, waste, or abuse.

Related Government Programs

NIH Research Grants
Biotechnology Research and Development Contracts
Vaccine Development Programs
Infectious Disease Research

Risk Flags

Cost Plus Fixed Fee contract type
Long contract duration
Potential for unforeseen research challenges in vaccine development

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $11.3 million to ACCESS TO ADVANCED HEALTH INSTITUTE. IGF:OT::IGF - ADVANCED DEVELOPMENT AND CLINICAL EVALUATION OF A SYNTHETIC INTRANASAL ENTAMOEBA HISTOLYTICA VACCINE CONTAINING ADJUVANT.

Who is the contractor on this award?

The obligated recipient is ACCESS TO ADVANCED HEALTH INSTITUTE.

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 $11.3 million.

What is the period of performance?

Start: 2018-09-21. End: 2026-08-31.

What is the track record of Access to Advanced Health Institute in securing and successfully completing government contracts, particularly in vaccine development?

Access to Advanced Health Institute (AAHI) is the contractor for this definitive contract. A review of publicly available contract data indicates that AAHI has been awarded other federal contracts, primarily through the National Institutes of Health (NIH). While specific details on their success rate or past performance in vaccine development are not immediately available in this dataset, their selection for this significant R&D effort suggests they possess the requisite qualifications and capabilities. Further investigation into their contract history, including past performance evaluations and any reported issues, would be necessary for a comprehensive assessment of their track record.

How does the Cost Plus Fixed Fee (CPFF) structure compare to other contract types for similar R&D projects, and what are the implications for cost control?

The Cost Plus Fixed Fee (CPFF) contract type is common for research and development projects where the scope of work is not precisely defined at the outset, making it difficult to establish a firm fixed price. In a CPFF contract, the government reimburses the contractor for all allowable costs incurred and pays a predetermined fixed fee representing profit. This structure incentivizes the contractor to control costs, as the fee remains constant regardless of the final cost. However, it also carries risks for the government, as the total cost can exceed initial estimates if actual costs are higher than anticipated. Compared to Firm-Fixed-Price (FFP) contracts, CPFF offers more flexibility for evolving R&D but less cost certainty. Other cost-reimbursement types, like Cost Plus Incentive Fee (CPIF), might offer better cost control through performance incentives.

What are the key performance indicators (KPIs) used to measure the success of this vaccine development contract, and how is progress tracked?

While the specific Key Performance Indicators (KPIs) for this contract are not detailed in the provided data, typical metrics for vaccine development contracts include milestones related to preclinical testing (e.g., efficacy in animal models, safety profiles), formulation stability, manufacturing process development, and progression through clinical trial phases (Phase I, II, III). Progress is generally tracked through regular technical and financial progress reports submitted by the contractor to the contracting officer and scientific monitors at the National Institutes of Health (NIH). Milestones within the contract's Statement of Work (SOW) would likely be tied to specific deliverables and funding tranches, allowing for phased oversight and evaluation of the research's advancement.

What is the historical spending pattern for Entamoeba histolytica vaccine research by the Department of Health and Human Services (HHS)?

Analyzing the historical spending patterns for Entamoeba histolytica vaccine research by HHS provides context for the current $11.26 million award. Without access to a comprehensive historical spending database specifically for this pathogen and vaccine type, a precise trend is difficult to establish. However, NIH, as the awarding agency, consistently funds research into infectious diseases and vaccine development. Spending in this area can fluctuate based on emerging health threats, scientific breakthroughs, and national health priorities. A review of NIH's budget allocations and specific grant/contract awards over the past decade would reveal the level of sustained investment in amoebiasis research and vaccine candidates, indicating whether this current award represents a significant increase, a continuation, or a new focus area.

Are there any known risks associated with synthetic intranasal vaccine technology, and how are these being mitigated in this contract?

Synthetic intranasal vaccine technology, while promising for ease of administration and potential for mucosal immunity, can present specific risks. These may include challenges in achieving consistent immunogenicity across diverse populations, potential for local inflammatory responses in the nasal passages, and ensuring long-term stability of the synthetic components. Mitigation strategies within this contract would likely involve rigorous preclinical safety and efficacy testing, detailed pharmacokinetic and pharmacodynamic studies, and careful selection of adjuvant and delivery systems. The 'advanced development and clinical evaluation' phases explicitly aim to identify and address such risks through structured scientific inquiry and phased clinical trials, ensuring that safety and efficacy are thoroughly assessed before widespread application.

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: BASIC RESEARCH

Solicitation ID: HHSNIHNIAIDBAA20171

Offers Received: 24

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 1616 EASTLAKE AVE E, SEATTLE, WA, 98102

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: $18,844,434

Exercised Options: $11,260,157

Current Obligation: $11,260,157

Actual Outlays: $4,696,822

Subaward Activity

Number of Subawards: 9

Total Subaward Amount: $3,922,460

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline