HHS awards $10.3M for anthrax vaccine evaluation, focusing on antigen-sparing trial

Contract Overview

Contract Amount: $10,320,205 ($10.3M)

Contractor: Icon Government and Public Health Solutions, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-13

End Date: 2027-09-12

Contract Duration: 1,825 days

Daily Burn Rate: $5.7K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: CTPE ANTHRAX AV7909 BOOST EVALUATION AND ANTIGEN-SPARING TRIAL (ABEAST)

Place of Performance

Location: HINCKLEY, MEDINA County, OHIO, 44233

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $10.3 million to ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC. for work described as: CTPE ANTHRAX AV7909 BOOST EVALUATION AND ANTIGEN-SPARING TRIAL (ABEAST) Key points: 1. Contract value appears reasonable for a multi-year R&D effort in a critical public health area. 2. Full and open competition suggests a robust market for these specialized research services. 3. Potential risks include scientific uncertainty inherent in early-stage vaccine research and development. 4. Performance context is a crucial evaluation of a novel approach to anthrax countermeasures. 5. This contract positions the government to advance biodefense capabilities against anthrax. 6. The fixed-fee structure on a cost-plus award provides some cost control for the government.

Value Assessment

Rating: good

The contract's value of $10.3 million over five years for an anthrax vaccine evaluation and antigen-sparing trial appears to be within a reasonable range for specialized research and development in biodefense. Benchmarking against similar government-funded R&D contracts for vaccine development or biodefense countermeasures suggests that this level of investment is typical for early-stage research and clinical trial support. The cost-plus-fixed-fee (CPFF) pricing structure allows for flexibility in research while providing a defined profit margin for the contractor, which can be a good balance for complex, evolving projects.

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 were invited to submit proposals. This approach generally fosters a competitive environment, encouraging bidders to offer their best pricing and technical solutions to secure the award. The specific number of bidders is not provided, but the 'full and open' designation suggests a healthy level of interest and capability within the market for this type of specialized research.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it typically leads to more competitive pricing and a wider range of innovative solutions, maximizing the value for public funds invested in critical research.

Public Impact

The primary beneficiaries are the public, through enhanced preparedness against anthrax threats. Services delivered include critical evaluation of a novel anthrax vaccine and its antigen-sparing potential. Geographic impact is national, focusing on improving biodefense capabilities for the United States. Workforce implications include support for specialized scientific and research personnel in the biotechnology sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep in R&D projects if research objectives are not tightly managed.
Reliance on contractor's scientific expertise requires robust government oversight and technical evaluation.
Uncertainty in research outcomes could impact the timeline and ultimate success of the trial.

Positive Signals

Focus on antigen-sparing technology represents an innovative approach to vaccine development.
Contract addresses a critical national security and public health threat (anthrax).
Awarding under full and open competition suggests a strong market and potential for high-quality research.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a critical component of the broader healthcare and defense industries. The market for biodefense research is specialized, driven by government funding and the need for countermeasures against biological threats. Spending in this area is often characterized by long-term investments in innovation and product development, with significant government contracts awarded to companies with proven expertise in areas like vaccine development and infectious disease research. Comparable spending benchmarks would typically be found in federal solicitations for similar advanced research projects.

Small Business Impact

The contract was awarded to ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC. and does not indicate any specific small business set-aside provisions. Given the specialized nature of biotechnology R&D, it is possible that larger, established firms with extensive experience and infrastructure are better positioned to compete. However, the prime contractor may engage small businesses as subcontractors for specific services or research components, contributing to the broader small business ecosystem.

Oversight & Accountability

Oversight for this contract will likely be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. Mechanisms would include regular progress reports, technical reviews, and financial audits to ensure adherence to the contract's objectives and budget. The CPFF structure necessitates careful monitoring of costs against the fixed fee. Transparency is generally maintained through contract award databases and public reporting of federal spending, though specific research details may be sensitive.

Related Government Programs

Biodefense Countermeasures
Vaccine Research and Development
Biotechnology Research
Public Health Preparedness
National Institutes of Health (NIH) Research Grants
Department of Defense (DoD) Biodefense Programs

Risk Flags

Scientific Uncertainty
Research & Development Risk
Potential for Delays
Reliance on Contractor Expertise

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $10.3 million to ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC.. CTPE ANTHRAX AV7909 BOOST EVALUATION AND ANTIGEN-SPARING TRIAL (ABEAST)

Who is the contractor on this award?

The obligated recipient is ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, 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 $10.3 million.

What is the period of performance?

Start: 2022-09-13. End: 2027-09-12.

What is the specific scientific objective of the 'antigen-sparing trial' mentioned in the contract?

The 'antigen-sparing trial' aims to evaluate an anthrax vaccine that requires fewer antigens (the parts of a pathogen that trigger an immune response) to be effective. This approach could potentially lead to vaccines that are easier, faster, and cheaper to produce, and may also elicit a broader or more potent immune response. The goal is to assess the efficacy and safety of such a vaccine, potentially offering a more efficient countermeasure against anthrax compared to traditional vaccine formulations that might require more complex manufacturing processes or larger doses.

How does the Cost Plus Fixed Fee (CPFF) pricing structure work for this R&D contract?

Under a Cost Plus Fixed Fee (CPFF) contract, the government reimburses the contractor for all allowable costs incurred during the performance of the contract, plus a predetermined fixed fee representing the contractor's profit. For this $10.3 million contract, the fixed fee is a set amount agreed upon before work begins. This structure is common for research and development where the scope of work can be uncertain. It provides the contractor with an incentive to control costs, as their profit is fixed regardless of the final cost of the project, while allowing flexibility for the government to adapt to research findings.

What are the potential risks associated with evaluating a novel vaccine technology?

Evaluating a novel vaccine technology carries inherent risks, including scientific uncertainty regarding efficacy and safety, potential for unexpected side effects, and challenges in scaling up production if the technology proves successful. There's also the risk that the vaccine may not perform as expected in trials, leading to delays or the need for significant redesign. Furthermore, regulatory hurdles for new vaccine approvals can be complex and time-consuming. The government must carefully manage these risks through rigorous oversight, phased research approaches, and contingency planning.

What is the significance of developing new anthrax countermeasures for public health preparedness?

Anthrax is considered a potential bioterrorism agent, and the development of effective countermeasures is crucial for national security and public health preparedness. A robust supply of safe and effective anthrax vaccines is essential to protect military personnel and civilian populations in the event of an attack. Innovations like antigen-sparing technologies could significantly improve the speed and cost-effectiveness of vaccine production, ensuring a more rapid and widespread response capability. This contract directly contributes to strengthening the nation's defenses against biological threats.

Can ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC. provide adequate R&D support for this specialized biodefense trial?

ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC. is a significant player in clinical research and public health solutions, often working with government agencies. Their track record typically includes managing complex clinical trials and providing scientific expertise across various therapeutic areas. For a biodefense trial, their ability to execute would depend on their specific experience with infectious diseases, vaccine development, and adherence to stringent government research protocols. The award under full and open competition suggests that the contracting agency assessed ICON's capabilities as sufficient to meet the demanding requirements of this R&D effort.

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

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 1265 RIDGE RD STE A, HINCKLEY, OH, 44233

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

Financial Breakdown

Contract Ceiling: $13,130,463

Exercised Options: $10,320,205

Current Obligation: $10,320,205

Actual Outlays: $6,577,812

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50120D00017

IDV Type: IDC

Timeline