HHS awards $3.46M for Epstein-Barr virus vaccine manufacturing, with NIH overseeing production

Contract Overview

Contract Amount: $3,460,074 ($3.5M)

Contractor: Mriglobal

Awarding Agency: Department of Health and Human Services

Start Date: 2025-09-22

End Date: 2027-09-21

Contract Duration: 729 days

Daily Burn Rate: $4.7K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: MANUFACTURE OF CLINICAL GRADE EPSTEIN-BARR VIRUS VACCINE

Place of Performance

Location: KANSAS CITY, JACKSON County, MISSOURI, 64110

State: Missouri Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $3.5 million to MRIGLOBAL for work described as: MANUFACTURE OF CLINICAL GRADE EPSTEIN-BARR VIRUS VACCINE Key points: 1. The contract focuses on manufacturing a clinical-grade vaccine, indicating a critical step in the drug development pipeline. 2. The fixed-price contract structure aims to control costs and provide predictability for the government. 3. The duration of the contract (729 days) suggests a phased approach to manufacturing and quality assurance. 4. The award to MRIGLOBAL, a research organization, points to specialized expertise in vaccine development and production. 5. The National Institutes of Health's involvement highlights a focus on public health initiatives and scientific advancement. 6. The contract's value is relatively modest for vaccine development, suggesting it may cover a specific phase or scale.

Value Assessment

Rating: good

The contract value of $3.46 million for clinical-grade vaccine manufacturing appears reasonable for a specialized research and development effort. Benchmarking against similar early-stage vaccine production contracts is challenging due to the highly specific nature of the work and the proprietary aspects of vaccine development. However, the firm fixed-price structure suggests an effort to achieve cost certainty. The contract's scope, focused on manufacturing, implies a defined deliverable that can be assessed for value.

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 had the opportunity to bid. This process is designed to foster a competitive environment, potentially leading to better pricing and innovation. The specific number of bidders is not provided, but the open competition suggests a robust selection process.

Taxpayer Impact: Full and open competition generally benefits taxpayers by promoting a wider range of offers and potentially driving down costs through market forces.

Public Impact

The primary beneficiaries are public health initiatives aimed at combating the Epstein-Barr virus. The contract will deliver clinical-grade Epstein-Barr virus vaccine manufacturing services. The geographic impact is centered in Missouri, where MRIGLOBAL is located, but the ultimate impact is global public health. Workforce implications include specialized roles in vaccine manufacturing, quality control, and research within MRIGLOBAL.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for delays in manufacturing if unforeseen technical challenges arise.
Dependence on the contractor's specialized facilities and expertise for successful production.
The long-term efficacy and market adoption of the vaccine are outside the scope of this manufacturing contract.

Positive Signals

Focus on clinical-grade manufacturing ensures adherence to strict quality and safety standards.
The firm fixed-price contract provides cost certainty for the government.
Awarding to a research organization like MRIGLOBAL leverages specialized scientific capabilities.
The contract duration allows for methodical production and quality assurance processes.

Sector Analysis

The pharmaceutical and biotechnology sector is characterized by high R&D investment, stringent regulatory oversight, and significant market potential for successful therapies and vaccines. The market for vaccines is substantial, driven by public health needs and government procurement. This contract fits within the broader R&D and manufacturing segment of the healthcare sector, specifically focusing on viral disease prevention. Comparable spending benchmarks are difficult to establish precisely due to the early-stage nature of vaccine development and manufacturing, but significant government investment is common in this area.

Small Business Impact

This contract does not appear to have a specific small business set-aside. The award to MRIGLOBAL, a research organization, suggests a focus on specialized capabilities rather than broad subcontracting opportunities for small businesses. However, MRIGLOBAL may engage small businesses for specific support services or supplies as part of its operations, though this is not explicitly detailed in the award information.

Oversight & Accountability

Oversight for this contract will likely be managed by the National Institutes of Health (NIH), a division of HHS. The firm fixed-price nature of the contract provides a degree of financial oversight. Accountability measures will be tied to the successful manufacturing of clinical-grade vaccine doses according to agreed-upon specifications and timelines. Transparency is facilitated by the public nature of federal contract awards, though specific manufacturing details may be proprietary.

Related Government Programs

National Institutes of Health Research and Development
Department of Health and Human Services Vaccine Programs
Biotechnology and Pharmaceutical Manufacturing Contracts
Clinical Trial Support Services

Risk Flags

Manufacturing quality risk
Schedule delay risk
Technical feasibility risk

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $3.5 million to MRIGLOBAL. MANUFACTURE OF CLINICAL GRADE EPSTEIN-BARR VIRUS VACCINE

Who is the contractor on this award?

The obligated recipient is MRIGLOBAL.

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 $3.5 million.

What is the period of performance?

Start: 2025-09-22. End: 2027-09-21.

What is the specific stage of vaccine development this contract supports?

This contract specifically supports the 'MANUFACTURE OF CLINICAL GRADE EPSTEIN-BARR VIRUS VACCINE'. This indicates that the vaccine candidate has likely progressed beyond initial research and development phases and is ready for production under controlled, high-quality conditions suitable for use in clinical trials. Clinical-grade manufacturing implies adherence to Good Manufacturing Practices (GMP) and other regulatory standards necessary for human testing. The contract value of $3.46 million and a duration of 729 days suggest it covers a significant portion of the manufacturing process for a specific batch or set of batches intended for investigational use.

How does the $3.46 million contract value compare to typical vaccine manufacturing costs?

The $3.46 million contract value for manufacturing clinical-grade Epstein-Barr virus vaccine is relatively modest when compared to the total lifecycle costs of vaccine development, which can run into hundreds of millions or even billions of dollars from discovery through large-scale commercial production. However, for the specific phase of manufacturing clinical trial material, this amount is within a reasonable range. Costs can vary significantly based on the complexity of the vaccine platform (e.g., mRNA, viral vector, protein subunit), the required scale, the stringency of GMP requirements, and the specific analytical testing needed. This contract likely covers the production of a limited number of doses for early-phase human trials.

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

Key risks for the government include potential delays in the manufacturing timeline, which could impact the progression of clinical trials and the overall vaccine development schedule. There's also a risk related to the quality and consistency of the manufactured vaccine; failure to meet clinical-grade standards could necessitate costly rework or render the produced batches unusable. Furthermore, the contractor, MRIGLOBAL, might face unforeseen technical challenges in scaling up production or ensuring batch-to-batch uniformity, leading to cost overruns if not managed effectively within the fixed-price structure. Dependence on specialized facilities and expertise also poses a risk if the contractor experiences operational disruptions.

What is MRIGLOBAL's track record in vaccine manufacturing?

MRIGLOBAL is a non-profit Contract Research Organization (CRO) with extensive experience in research, development, and manufacturing, including work on vaccines and biologics. While specific details on their past Epstein-Barr virus vaccine manufacturing projects are not publicly detailed in this award notice, their general capabilities encompass process development, scale-up, and GMP manufacturing for various therapeutic modalities. Their track record suggests they possess the necessary infrastructure and expertise to undertake complex manufacturing tasks for clinical trials. Government agencies like NIH often partner with established CROs like MRIGLOBAL for such specialized projects, implying a level of confidence in their capabilities.

What are the historical spending patterns for Epstein-Barr virus vaccine research and development by the government?

Historical government spending on Epstein-Barr virus (EBV) vaccine research and development has been significant, though often spread across various research grants and contracts rather than concentrated in a single large program. Agencies like the National Institutes of Health (NIH) have consistently funded research into EBV due to its association with various cancers (like Burkitt's lymphoma and nasopharyngeal carcinoma) and autoimmune diseases. While specific aggregate spending figures for EBV vaccine R&D are not readily available, the cumulative investment over decades reflects the scientific community's long-standing interest in developing preventative measures against this widespread virus. This $3.46 million contract represents a continuation of that investment, focusing on a critical manufacturing step.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Management, Scientific, and Technical Consulting Services › Other Scientific and Technical Consulting Services

Product/Service Code: MEDICAL SERVICES › LABORATORY TESTING SERVICES

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: EBV-2025-01

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 425 DR MARTIN LUTHER KING JR BLVD, KANSAS CITY, MO, 64110

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: $3,460,074

Exercised Options: $3,460,074

Current Obligation: $3,460,074

Subaward Activity

Number of Subawards: 1

Total Subaward Amount: $2,922,394

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75N91023D00010

IDV Type: IDC

Timeline