HHS awards $29.6M contract for pandemic influenza vaccine patch development

Contract Overview

Contract Amount: $29,594,472 ($29.6M)

Contractor: Vaxxas PTY Ltd

Awarding Agency: Department of Health and Human Services

Start Date: 2020-09-29

End Date: 2026-12-30

Contract Duration: 2,283 days

Daily Burn Rate: $13.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: VAXXAS - DEVELOPMENT OF HD-MICRO ARRAY PATCH (MAP) TO DELIVER A VACCINE AGAINST A PANDEMIC STRAIN OF INFLUENZA, H5N1.

Plain-Language Summary

Department of Health and Human Services obligated $29.6 million to VAXXAS PTY LTD for work described as: VAXXAS - DEVELOPMENT OF HD-MICRO ARRAY PATCH (MAP) TO DELIVER A VACCINE AGAINST A PANDEMIC STRAIN OF INFLUENZA, H5N1. Key points: 1. Contract focuses on innovative vaccine delivery technology, potentially improving public health preparedness. 2. Research and Development in Biotechnology sector, a critical area for national security and health. 3. Long-duration contract suggests a complex, multi-phase development process. 4. Cost-plus-fixed-fee contract type may incentivize contractor efficiency while managing development risks. 5. Sole contractor indicates a specialized capability or a competitive process that yielded a single qualified bidder. 6. Potential for significant public health impact in the event of a pandemic influenza outbreak.

Value Assessment

Rating: fair

The contract value of $29.6 million for research and development in biotechnology is within a typical range for advanced medical countermeasures. However, without specific benchmarks for the development of HD-micro array patch technology for influenza vaccines, a precise value-for-money assessment is challenging. The cost-plus-fixed-fee structure allows for cost reimbursement plus a predetermined profit, which can be appropriate for R&D where costs are uncertain, but it requires careful oversight to ensure efficiency. Further analysis would involve comparing the projected outcomes and timelines against industry standards for similar developmental 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 capable vendors had the opportunity to bid. The fact that only one award was made suggests that VAXXAS PTY LTD was the most qualified or the only responsive bidder meeting the stringent requirements for this specialized research and development. This level of competition, while initially broad, resulted in a single award, which warrants scrutiny to ensure the government received the best possible value and that the solicitation was structured to encourage broader participation if feasible.

Taxpayer Impact: A full and open competition, even with a single award, suggests that the government sought the best solution available in the market. Taxpayers benefit from the assurance that the chosen technology was vetted against potential alternatives, though the limited number of bidders could imply a niche market or high barriers to entry.

Public Impact

The primary beneficiaries are the public, through the development of a new vaccine delivery system for pandemic influenza. Services delivered include research and development for a novel vaccine patch technology. Geographic impact is national, aiming to bolster the U.S. response to a pandemic. Workforce implications may include specialized roles in biotechnology research, development, and manufacturing.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost-plus-fixed-fee contracts can lead to cost overruns if not managed diligently.
Limited competition resulting in a sole award may indicate a lack of market depth or potential for higher pricing.
The long duration of the contract (over 6 years) increases the risk of scope creep or changing technological landscapes.

Positive Signals

Focus on a critical public health threat (pandemic influenza) aligns with national priorities.
Development of innovative delivery methods (micro array patch) could offer significant advantages over traditional methods.
Full and open competition, even with a single award, suggests an effort to find the best solution.

Sector Analysis

The contract falls within the Biotechnology Research and Development sector, a rapidly evolving field critical for public health and national security. This sector is characterized by high innovation, significant R&D investment, and long development cycles. Spending in this area is often driven by government initiatives to counter emerging threats, such as novel viruses and pandemics. Comparable spending benchmarks would typically involve other advanced R&D contracts for vaccine development or novel drug delivery systems, which can range from tens to hundreds of millions of dollars depending on the phase and complexity.

Small Business Impact

This contract does not appear to have a small business set-aside component, as indicated by 'ss': false and 'sb': false. The prime contractor, VAXXAS PTY LTD, is likely a larger entity or a specialized firm. There is no explicit information regarding subcontracting plans for small businesses. Future analysis could explore whether opportunities exist for small businesses to participate in specific aspects of the research, development, or manufacturing phases, or if the prime contractor has a history of engaging small businesses.

Oversight & Accountability

Oversight for this contract will likely be managed by the Department of Health and Human Services (HHS), specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). The cost-plus-fixed-fee structure necessitates robust financial oversight to monitor expenditures and ensure the fixed fee is earned appropriately. Performance metrics and milestones will be crucial for tracking progress. Transparency will depend on HHS's reporting practices and any public disclosures related to the project's outcomes. Inspector General jurisdiction would apply to any allegations of fraud, waste, or abuse.

Related Government Programs

Biotechnology Research and Development
Vaccine Development Programs
Pandemic Preparedness Initiatives
Advanced Medical Countermeasures

Risk Flags

Potential for cost overruns due to R&D uncertainty.
Risk of technological obsolescence or failure in a rapidly evolving field.
Dependence on a single contractor may limit future options or price negotiation.
Effectiveness of the patch technology requires validation through extensive testing.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $29.6 million to VAXXAS PTY LTD. VAXXAS - DEVELOPMENT OF HD-MICRO ARRAY PATCH (MAP) TO DELIVER A VACCINE AGAINST A PANDEMIC STRAIN OF INFLUENZA, H5N1.

Who is the contractor on this award?

The obligated recipient is VAXXAS PTY LTD.

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 $29.6 million.

What is the period of performance?

Start: 2020-09-29. End: 2026-12-30.

What is the track record of VAXXAS PTY LTD in developing similar vaccine technologies or delivery systems?

Information regarding the specific track record of VAXXAS PTY LTD in developing vaccine technologies or delivery systems is not provided in the data. As a single awardee under a full and open competition for a specialized R&D contract, it is presumed they possess the necessary expertise and intellectual property. Further investigation would require accessing contractor performance databases (like CPARS) or conducting market research to ascertain their history with government contracts, particularly those involving biotechnology, vaccine development, or novel drug delivery mechanisms. Understanding their past performance is crucial for assessing the likelihood of successful project completion and managing potential risks associated with their capabilities.

How does the awarded amount compare to similar R&D contracts for pandemic influenza countermeasures?

The awarded amount of $29.6 million for the development of an HD-micro array patch for pandemic influenza vaccine delivery is within the expected range for advanced research and development in this critical area. However, direct comparisons are challenging without more specific data on the scope, phase, and technological maturity of other similar contracts. Contracts for early-stage research might be smaller, while those involving late-stage development, clinical trials, and manufacturing scale-up can easily exceed hundreds of millions of dollars. The cost-plus-fixed-fee structure suggests a significant R&D component where costs are not fully predictable. Benchmarking would ideally involve analyzing contracts with similar technological approaches (e.g., microneedle patches, novel adjuvant development) and target pathogens.

What are the key performance indicators (KPIs) and milestones for this contract?

Specific Key Performance Indicators (KPIs) and milestones for this contract are not detailed in the provided data. However, for a research and development contract of this nature, typical KPIs would likely include successful demonstration of vaccine antigen stability on the patch, achievement of desired immune responses in preclinical models, successful scale-up of patch manufacturing processes, and adherence to regulatory pathways for potential future clinical trials. Milestones would be tied to the completion of specific research phases, such as proof-of-concept, preclinical efficacy studies, and formulation development. The cost-plus-fixed-fee structure implies that progress against these defined milestones would be essential for the contractor to earn their fixed fee.

What is the potential impact of this technology if successful, compared to traditional vaccine administration methods?

If successful, the HD-micro array patch technology for pandemic influenza vaccine delivery could offer significant advantages over traditional methods like intramuscular injections. Potential benefits include improved patient compliance due to ease of application, potentially enhanced and more durable immune responses through direct delivery to skin-resident immune cells, and the possibility of self-administration, which could be crucial during a widespread pandemic, reducing the burden on healthcare systems. Furthermore, patches may eliminate the need for cold-chain storage required for many injectable vaccines, simplifying logistics. The micro array aspect suggests precise dosing and potentially reduced antigen load.

What is the historical spending trend for pandemic influenza countermeasures by HHS?

Historical spending trends by the Department of Health and Human Services (HHS) on pandemic influenza countermeasures have varied significantly based on perceived threats and funding appropriations. In recent years, particularly following the COVID-19 pandemic, there has been a substantial increase in investment across various countermeasures, including vaccines, therapeutics, and diagnostics. Prior to major outbreaks, funding might have been more focused on basic research and preparedness planning. Specific figures for influenza countermeasures would require a detailed analysis of HHS's budget allocations over several fiscal years, looking at programs managed by agencies like the Office of the Assistant Secretary for Preparedness and Response (ASPR) and the National Institutes of Health (NIH).

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

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: SE 13.02 L 13 179 ELIZABETH ST, SYDNEY

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

Financial Breakdown

Contract Ceiling: $29,594,472

Exercised Options: $29,594,472

Current Obligation: $29,594,472

Actual Outlays: $25,646,618

Subaward Activity

Number of Subawards: 21

Total Subaward Amount: $10,071,388

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline