NIH awards $141.6M for advance universal influenza vaccine development to Leidos Biomedical Research Inc

Contract Overview

Contract Amount: $141,656,003 ($141.7M)

Contractor: Leidos Biomedical Research Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2021-02-16

End Date: 2031-01-28

Contract Duration: 3,633 days

Daily Burn Rate: $39.0K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: ADVANCE UNIVERSAL INFLUENZA VACCINE - FLU MOSAIC VERSION 2 (FLUMOSV2)

Place of Performance

Location: FREDERICK, FREDERICK County, MARYLAND, 21702

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $141.7 million to LEIDOS BIOMEDICAL RESEARCH INC for work described as: ADVANCE UNIVERSAL INFLUENZA VACCINE - FLU MOSAIC VERSION 2 (FLUMOSV2) Key points: 1. Contract focuses on critical R&D for a next-generation influenza vaccine. 2. Leidos Biomedical Research Inc. is the sole awardee. 3. Long contract duration suggests a phased development approach. 4. Cost-plus-fixed-fee structure incentivizes efficient cost management. 5. The contract falls under the R&D sector, specifically life sciences. 6. No small business set-aside was utilized for this award.

Value Assessment

Rating: good

The total award amount of $141.6 million over a potential 10-year period represents a significant investment in vaccine research. Benchmarking this against similar large-scale R&D contracts for vaccine development is challenging due to the specialized nature of universal influenza vaccine research. However, the cost-plus-fixed-fee (CPFF) contract type is common for complex R&D where costs are not easily predictable, aiming to balance contractor incentives with government oversight.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple offerors had the opportunity to bid. While the specific number of bidders is not provided, this competitive process is expected to yield a fair price for the research services. The government's ability to select from a range of qualified entities suggests a robust market for advanced vaccine development.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can lead to more cost-effective solutions and innovative approaches.

Public Impact

The primary beneficiaries are public health organizations and the general population, through the development of a more effective influenza vaccine. The contract aims to deliver advancements in vaccine technology, potentially leading to a universal flu vaccine. The geographic impact is national, with potential global health implications. Workforce implications include specialized R&D roles in biotechnology and life sciences.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long contract duration could lead to scope creep if not managed tightly.
Cost-plus-fixed-fee contracts require diligent oversight to ensure cost efficiency.

Positive Signals

Focus on a critical public health need (universal flu vaccine).
Awarded through full and open competition, suggesting market responsiveness.
Contractor has a history in biomedical research, indicating relevant expertise.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and biotechnology. The market for vaccine development is highly specialized, with significant government investment due to public health imperatives. Comparable spending benchmarks are difficult to establish precisely due to the unique nature of universal influenza vaccine research, but large-scale R&D efforts in this area typically involve substantial funding over extended periods.

Small Business Impact

This contract was not set aside for small businesses, nor does it appear to have specific subcontracting requirements for small businesses mentioned in the provided data. The focus on advanced R&D in a specialized field may lend itself to larger, established research institutions or companies with extensive capabilities, potentially limiting direct opportunities for smaller entities in the prime contract.

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. Given the R&D nature and CPFF structure, rigorous financial and technical oversight will be crucial. Transparency will depend on reporting requirements outlined in the contract and agency policies regarding research progress and expenditures.

Related Government Programs

National Institute of Allergy and Infectious Diseases (NIAID) vaccine research programs
Biomedical Advanced Research and Development Authority (BARDA) initiatives
Department of Defense vaccine research contracts

Risk Flags

Long contract duration requires sustained oversight.
CPFF structure necessitates careful cost monitoring.
R&D projects inherently carry scientific and technical risks.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $141.7 million to LEIDOS BIOMEDICAL RESEARCH INC. ADVANCE UNIVERSAL INFLUENZA VACCINE - FLU MOSAIC VERSION 2 (FLUMOSV2)

Who is the contractor on this award?

The obligated recipient is LEIDOS BIOMEDICAL RESEARCH INC.

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 $141.7 million.

What is the period of performance?

Start: 2021-02-16. End: 2031-01-28.

What is the specific scientific objective of the 'ADVANCE UNIVERSAL INFLUENZA VACCINE - FLU MOSAIC VERSION 2 (FLUMOSV2)'?

The 'ADVANCE UNIVERSAL INFLUENZA VACCINE - FLU MOSAIC VERSION 2 (FLUMOSV2)' contract aims to accelerate the development of a next-generation influenza vaccine that provides broad and durable protection against a wide range of influenza strains. This includes developing novel vaccine platforms and antigen designs that can elicit immune responses effective against both current and future circulating influenza viruses, thereby reducing the burden of seasonal influenza and pandemic threats. The 'mosaic' aspect likely refers to a strategy of presenting multiple viral antigens to the immune system to achieve broader coverage.

How does the Cost Plus Fixed Fee (CPFF) contract structure influence the contractor's performance and cost management for this R&D project?

The Cost Plus Fixed Fee (CPFF) structure means the contractor is reimbursed for all allowable costs incurred, plus a predetermined fixed fee representing profit. For R&D, this is often used when the scope and costs are uncertain. It incentivizes the contractor to control costs, as the fee remains fixed regardless of the final cost. However, it requires robust government oversight to ensure costs are reasonable and allocable. The contractor is motivated to complete the work efficiently to maximize their return on investment, but the government bears the primary cost risk.

What are the potential risks associated with a long-duration contract (over 10 years) for vaccine R&D?

Long-duration contracts for R&D, like this 10-year award, carry several risks. Scientific breakthroughs or shifts in research priorities could render the current approach obsolete, leading to wasted investment. Technological advancements might emerge from other sources, making the contracted research less competitive. Furthermore, maintaining consistent oversight and stakeholder engagement over such an extended period can be challenging. There's also a risk of 'scope creep' if the project's objectives are not tightly managed, potentially increasing costs beyond initial projections.

What is the significance of Leidos Biomedical Research Inc. being awarded this contract, considering their track record?

Leidos Biomedical Research Inc. operates the Frederick National Laboratory for Cancer Research (FNLCR) under contract with the National Cancer Institute (NCI), part of NIH. This extensive experience in managing large-scale, complex biomedical research programs, including vaccine development and infectious disease research, positions them as a highly capable contractor for this advanced influenza vaccine project. Their established infrastructure, scientific expertise, and history of working with government agencies on critical health initiatives suggest a strong potential for successful execution of the contract's objectives.

How does this $141.6 million investment compare to historical federal spending on influenza vaccine research?

Federal spending on influenza vaccine research is substantial and ongoing, driven by the need for annual updates and the pursuit of a universal vaccine. While $141.6 million over 10 years is a significant sum for a single project, it represents a portion of the broader federal investment. Agencies like NIH and CDC, along with BARDA, collectively spend hundreds of millions annually on influenza surveillance, vaccine development, and manufacturing preparedness. This contract is likely part of a larger, multi-pronged federal strategy to enhance influenza defense, rather than an isolated expenditure.

What are the implications of this contract for the broader goal of pandemic preparedness?

This contract is directly relevant to pandemic preparedness by aiming to develop a universal influenza vaccine. Such a vaccine would eliminate the need for annual reformulation and manufacturing of seasonal flu shots, significantly reducing the time lag in responding to novel or highly virulent influenza strains that could cause a pandemic. By investing in foundational R&D for a broadly protective vaccine, the government is taking a proactive step to bolster national and global health security against future influenza pandemics.

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

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Parent Company: Leidos Holdings, Inc.

Address: 1050 BOYLES ST, FREDERICK, MD, 21702

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

Financial Breakdown

Contract Ceiling: $142,262,456

Exercised Options: $141,656,003

Current Obligation: $141,656,003

Actual Outlays: $26,034,038

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Parent Contract

Parent Award PIID: 75N91019D00024

IDV Type: IDC

Timeline