HHS awards $22.8M for influenza vaccine R&D, with GSK to develop H5N8 candidate

Contract Overview

Contract Amount: $22,877,697 ($22.9M)

Contractor: Glaxosmithkline, LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-14

End Date: 2025-06-30

Contract Duration: 1,020 days

Daily Burn Rate: $22.4K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: THE PURPOSE OF THIS TASK ORDER IS TO PROCURE INFLUENZA A/ASTRAKHAN/3212/2020 (H5N8) VIRUS VACCINE CANDIDATE AND CLINICAL TRIAL FOR THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER IDIQ CONTRACT # 75A50122D00002 BASE PERIOD.

Place of Performance

Location: DURHAM, DURHAM County, NORTH CAROLINA, 27709

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $22.9 million to GLAXOSMITHKLINE, LLC for work described as: THE PURPOSE OF THIS TASK ORDER IS TO PROCURE INFLUENZA A/ASTRAKHAN/3212/2020 (H5N8) VIRUS VACCINE CANDIDATE AND CLINICAL TRIAL FOR THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER IDIQ CONTRACT # 75A50122D00002 BASE PERIOD. Key points: 1. Contract focuses on critical R&D for a specific influenza strain, addressing public health preparedness. 2. The award utilizes a Firm Fixed Price structure, providing cost certainty for the government. 3. Competition was full and open, suggesting a broad market search for qualified contractors. 4. The contract duration of over 1000 days indicates a significant, multi-year research effort. 5. This award falls under a larger IDIQ contract, suggesting a pre-vetted framework for procurements. 6. The specific vaccine candidate targets a potentially pandemic influenza strain, highlighting its strategic importance.

Value Assessment

Rating: good

The total award of $22.88 million for the development of an influenza vaccine candidate and clinical trial appears reasonable given the scope and duration. Benchmarking against similar R&D contracts for vaccine development is challenging without more specific details on the phase of research and the complexity of the candidate. However, the firm fixed-price nature of the contract suggests that the contractor has assessed the risks and costs associated with the project, and the government has secured a defined price.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that the Department of Health and Human Services sought proposals from all responsible sources. This approach generally promotes a competitive environment, encouraging multiple bidders to offer their best technical solutions and pricing. The specific number of bidders is not provided, but the open competition suggests a robust process for selecting the most capable contractor for this critical R&D effort.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it increases the likelihood of obtaining the best value by fostering a competitive environment that can drive down prices and improve the quality of services.

Public Impact

The primary beneficiaries are the public, through the development of a vaccine candidate against a potentially pandemic influenza strain. The services delivered include the procurement of an influenza A/Astrakhan/3212/2020 (H5N8) virus vaccine candidate and associated clinical trials. The geographic impact is national, focusing on public health preparedness within the United States. Workforce implications may include employment opportunities within GlaxoSmithKline for researchers, clinicians, and support staff involved in vaccine development and testing.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for delays in clinical trial phases impacting the timeline for vaccine availability.
Unforeseen scientific challenges in developing a stable and effective vaccine candidate.
Reliance on a single contractor (GSK) for this specific vaccine development task order.

Positive Signals

Award to a well-established pharmaceutical company with a proven track record in vaccine development.
Focus on a specific, high-priority influenza strain (H5N8) demonstrates proactive public health strategy.
Firm fixed-price contract provides cost predictability for the government.
Contract is part of a larger IDIQ, suggesting a streamlined and pre-vetted procurement process.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, specifically focusing on vaccine development. The market for vaccine R&D is highly specialized, involving a limited number of large pharmaceutical companies and specialized biotech firms. Government funding plays a crucial role in advancing novel vaccine candidates, particularly for emerging infectious diseases and pandemic preparedness. Comparable spending benchmarks in this area are difficult to establish precisely due to the unique nature of each R&D project, but significant investments are common for novel vaccine development and clinical trials.

Small Business Impact

The contract was awarded under full and open competition and does not indicate any specific small business set-aside. GlaxoSmithKline, LLC is a large business. There is no explicit information provided regarding subcontracting plans for small businesses. The impact on the small business ecosystem is likely minimal for this specific task order, as the primary awardee is a large entity, though subcontracting opportunities could potentially arise.

Oversight & Accountability

Oversight for this contract is managed by the Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). As a task order under an IDIQ contract, it likely adheres to the oversight mechanisms established for the parent contract. Transparency is facilitated through federal contract databases. Accountability measures are inherent in the firm fixed-price contract terms and the requirement for successful completion of vaccine candidate development and clinical trials. The Inspector General for HHS would have jurisdiction over potential fraud, waste, or abuse.

Related Government Programs

Influenza Vaccine Research and Development
Biotechnology Research Contracts
Public Health Emergency Preparedness
Department of Health and Human Services IDIQ Contracts
Clinical Trial Services

Risk Flags

Potential for scientific failure
Risk of clinical trial delays
Dependence on specific strain research
Long development timeline

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $22.9 million to GLAXOSMITHKLINE, LLC. THE PURPOSE OF THIS TASK ORDER IS TO PROCURE INFLUENZA A/ASTRAKHAN/3212/2020 (H5N8) VIRUS VACCINE CANDIDATE AND CLINICAL TRIAL FOR THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER IDIQ CONTRACT # 75A50122D00002 BASE PERIOD.

Who is the contractor on this award?

The obligated recipient is GLAXOSMITHKLINE, LLC.

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 $22.9 million.

What is the period of performance?

Start: 2022-09-14. End: 2025-06-30.

What is GlaxoSmithKline's track record in developing influenza vaccines?

GlaxoSmithKline (GSK) is a major global pharmaceutical company with a long and extensive history in vaccine development, including influenza vaccines. They are one of the world's largest manufacturers of seasonal flu vaccines, producing hundreds of millions of doses annually. GSK has experience with various vaccine technologies and has navigated the complex regulatory pathways for vaccine approval. Their expertise spans research, development, manufacturing, and distribution of vaccines. This background suggests they possess the necessary capabilities and experience to undertake the development of the H5N8 influenza vaccine candidate and conduct the associated clinical trials as required by the Department of Health and Human Services.

How does the $22.88 million cost compare to similar influenza vaccine R&D contracts?

Directly comparing the $22.88 million cost to similar influenza vaccine R&D contracts is challenging without detailed project scope and phase information. However, the development of a novel vaccine candidate, including preclinical research and early-stage clinical trials, is a complex and expensive undertaking. Costs can range from tens of millions to hundreds of millions of dollars depending on the vaccine type, target pathogen, research phase, and the number of clinical trial participants. Given that this award covers the procurement of a candidate and clinical trials, the amount appears to be within a reasonable range for such a critical public health initiative, especially considering the potential for pandemic threats.

What are the primary risks associated with this contract for the government?

The primary risks for the government in this contract revolve around the inherent uncertainties of research and development. Firstly, there is a scientific risk that the H5N8 vaccine candidate may not prove to be effective or safe during preclinical or clinical trials, leading to project failure despite the investment. Secondly, there is a timeline risk; vaccine development is often subject to delays due to unforeseen scientific hurdles, manufacturing challenges, or regulatory review processes, potentially impacting the readiness for a public health emergency. Lastly, while the contract is firm fixed-price, there's a residual risk of cost overruns if unforeseen issues require significant scope adjustments or additional funding requests, although the FFP structure aims to mitigate this.

How effective is the 'full and open competition' strategy for procuring specialized R&D like vaccine development?

Full and open competition is generally considered the most effective strategy for procuring specialized R&D like vaccine development because it maximizes the pool of potential offerors, increasing the likelihood of finding the most innovative and cost-effective solutions. By allowing all responsible sources to compete, the government can access a wider range of expertise and technologies. This competitive pressure can also lead to better pricing and terms. For vaccine development, where scientific expertise and specialized facilities are critical, open competition ensures that the government isn't limited to a pre-selected few, potentially uncovering niche capabilities or novel approaches that might otherwise be missed. It also enhances transparency and public trust in the procurement process.

What is the historical spending pattern for influenza vaccine R&D by HHS?

The Department of Health and Human Services (HHS), particularly through agencies like the Biomedical Advanced Research and Development Authority (BARDA) within ASPR, has a history of significant investment in influenza vaccine research and development. This spending is often driven by pandemic preparedness initiatives and the need to stay ahead of evolving viral strains. Historical spending patterns show consistent funding allocated towards developing new vaccine candidates, improving existing ones, and conducting clinical trials, especially for novel or highly pathogenic strains like H5N1 and H7N9, and by extension, H5N8. These investments fluctuate based on perceived threats and scientific advancements but represent a sustained commitment to bolstering the nation's vaccine capabilities.

What are the implications of this contract being a 'Task Order' under an IDIQ?

This contract being a Task Order under an Indefinite Delivery/Indefinite Quantity (IDIQ) contract means that the foundational agreement (the IDIQ) was already established through a competitive process, likely outlining general terms, conditions, and capabilities. The Task Order then specifies the particular work to be performed, such as the development of the H5N8 vaccine candidate and clinical trials, along with its associated cost and schedule. This structure allows for more agile and efficient procurement of services over time, as the basic contract is already in place. It implies that HHS has pre-qualified contractors like GlaxoSmithKline, LLC under the IDIQ, streamlining the process for specific project needs and potentially reducing administrative burden compared to starting a new procurement from scratch.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: MEDICAL/DENTAL/VETERINARY EQPT/SUPP

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 5 MOORE DR RESEARCH TRIANGLE PK, DURHAM, NC, 27709

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: $22,877,697

Exercised Options: $22,877,697

Current Obligation: $22,877,697

Actual Outlays: $22,877,697

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50122D00002

IDV Type: IDC

Timeline