HHS awards $19.6M for CBRN mRNA vaccine development, with a 5-year performance period

Contract Overview

Contract Amount: $19,620,884 ($19.6M)

Contractor: Advanced Technology International

Awarding Agency: Department of Health and Human Services

Start Date: 2024-06-20

End Date: 2029-09-30

Contract Duration: 1,928 days

Daily Burn Rate: $10.2K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: OTA AWARD FOR BIOMAP TASK ORDER #7 FOR CBRN AVAT_MRNA

Place of Performance

Location: SUMMERVILLE, BERKELEY County, SOUTH CAROLINA, 29486

State: South Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $19.6 million to ADVANCED TECHNOLOGY INTERNATIONAL for work described as: OTA AWARD FOR BIOMAP TASK ORDER #7 FOR CBRN AVAT_MRNA Key points: 1. Contract value represents a significant investment in biodefense preparedness. 2. The award is a delivery order under an existing Other Transaction Authority (OTA) agreement. 3. Performance period extends over five years, indicating a long-term need. 4. The contractor, Advanced Technology International, has a history of supporting government R&D. 5. The specific task order focuses on mRNA vaccine development for CBRN threats. 6. The contract type is Firm Fixed Price, which shifts cost risk to the contractor.

Value Assessment

Rating: good

The contract value of $19.6 million for a 5-year task order for CBRN mRNA vaccine development appears reasonable given the specialized nature of the work. Benchmarking against similar R&D contracts in biodefense is challenging due to the unique requirements and evolving threat landscape. However, the firm-fixed-price structure suggests a defined scope and cost expectation, which is generally favorable for value.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. The specific details on the number of bidders are not provided in the summary data, but the 'full-and-open' designation suggests a competitive process was utilized. This approach is intended to foster price discovery and ensure the government receives the best value.

Taxpayer Impact: A full and open competition generally benefits taxpayers by driving down costs through competitive bidding and encouraging innovation among a wider pool of potential contractors.

Public Impact

The primary beneficiaries are the U.S. public, through enhanced preparedness against chemical, biological, radiological, and nuclear (CBRN) threats. The services delivered involve the development and potential manufacturing of mRNA vaccines. The geographic impact is national, focusing on U.S. biodefense capabilities. Workforce implications may include specialized roles in biotechnology, vaccine development, and manufacturing.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep in long-term R&D projects.
Reliance on a single task order under an OTA may limit broader market engagement.
The evolving nature of mRNA technology could present unforeseen development challenges.

Positive Signals

Firm Fixed Price contract type provides cost certainty.
Full and open competition suggests a robust selection process.
Long performance period allows for sustained development and refinement.

Sector Analysis

This contract falls within the broader biopharmaceutical and biotechnology sector, specifically focusing on advanced vaccine development for national security threats. The market for CBRN countermeasures is specialized, driven by government funding and research initiatives. Comparable spending benchmarks are difficult to establish precisely due to the unique nature of mRNA technology and the specific threat focus, but investments in pandemic preparedness and biodefense are significant government priorities.

Small Business Impact

The provided data does not indicate any specific small business set-aside or subcontracting requirements for this particular task order. As it was awarded under full and open competition, the primary contractor, Advanced Technology International, likely managed the award. Further analysis would be needed to determine if small businesses are involved in the subcontracting chain.

Oversight & Accountability

Oversight for this contract would typically fall under the Department of Health and Human Services (HHS), specifically the Office of the Assistant Secretary for Preparedness and Response (ASPR). As an Other Transaction Authority (OTA) award, oversight mechanisms may differ slightly from traditional FAR-based contracts. Transparency is generally maintained through contract databases, but detailed programmatic oversight is internal to the agency.

Related Government Programs

Biodefense Advanced Research Projects Agency (BARDA) initiatives
National Institutes of Health (NIH) vaccine research programs
Department of Defense (DoD) biosecurity research
Strategic National Stockpile (SNS) procurements

Risk Flags

Long-term R&D project risks
Potential for evolving threat landscape
Reliance on emerging technology (mRNA)

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $19.6 million to ADVANCED TECHNOLOGY INTERNATIONAL. OTA AWARD FOR BIOMAP TASK ORDER #7 FOR CBRN AVAT_MRNA

Who is the contractor on this award?

The obligated recipient is ADVANCED TECHNOLOGY INTERNATIONAL.

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 $19.6 million.

What is the period of performance?

Start: 2024-06-20. End: 2029-09-30.

What is the track record of Advanced Technology International (ATI) in supporting government biodefense research and development contracts?

Advanced Technology International (ATI) is a non-profit company that serves as a trusted partner for the U.S. government, particularly in the defense and national security sectors. They specialize in managing Other Transaction Authority (OTA) agreements, which are flexible mechanisms used to accelerate research, development, and prototyping. ATI has a significant history of facilitating contracts for agencies like the Department of Defense and Department of Health and Human Services, often focusing on emerging technologies and critical national security needs. Their experience includes managing complex R&D projects, fostering collaboration between government, industry, and academia, and navigating the unique requirements of OTA awards. This background suggests ATI is well-positioned to manage the BioMap Task Order #7 for CBRN mRNA vaccine development, given their established processes and government relationships.

How does the $19.6 million value of this task order compare to other government investments in CBRN vaccine development?

The $19.6 million value for this specific task order represents a focused investment in the development of CBRN mRNA vaccines over a five-year period. It is important to note that this is a single task order under a broader Other Transaction Authority (OTA) agreement, and the total value of the overarching OTA could be significantly higher. Government investments in CBRN countermeasures are substantial and can range from early-stage research grants costing hundreds of thousands of dollars to large-scale procurement contracts for approved medical countermeasures that can reach billions. For instance, Operation Warp Speed saw billions invested in COVID-19 vaccine development and manufacturing. While direct comparisons are difficult due to the specific nature of CBRN threats and the evolving mRNA technology, $19.6 million for a dedicated development effort over five years is a significant, but not unprecedented, allocation within the broader biodefense funding landscape.

What are the primary risks associated with developing mRNA vaccines for CBRN threats under this contract?

Developing mRNA vaccines for Chemical, Biological, Radiological, and Nuclear (CBRN) threats presents several key risks. Firstly, the scientific and technical risk is high; mRNA technology, while promising, is still evolving, and its efficacy and safety against a wide range of novel CBRN agents may not be fully understood or guaranteed. Secondly, there's a risk of pathogen evolution or the emergence of new threats that could render the developed vaccine obsolete. Thirdly, manufacturing and scalability pose challenges; producing large quantities of specialized mRNA vaccines rapidly and at scale, especially under firm-fixed-price conditions, can be difficult if unforeseen production issues arise. Finally, regulatory hurdles for novel countermeasures can be complex and time-consuming, potentially delaying deployment even after successful development. The five-year performance period aims to mitigate some of these risks through sustained effort and iterative development.

What does the 'Biological Product (except Diagnostic) Manufacturing' (ND) classification imply for the scope of this contract?

The North American Industry Classification System (NAICS) code '325414 - Biological Product (except Diagnostic) Manufacturing' indicates that the primary focus of this contract is on the manufacturing of biological products, excluding diagnostics. For this specific task order concerning CBRN mRNA vaccines, this classification suggests that the work will likely involve the development, production, and potentially scaling up of mRNA vaccine candidates. This could encompass activities such as process development, formulation, quality control, and pilot-scale manufacturing. While the contract is for 'development,' the NAICS code points towards an end goal or significant component related to the manufacturing readiness or actual production of these biological products, rather than purely theoretical research or laboratory-scale synthesis.

How does the 'Firm Fixed Price' (PT) contract type influence the contractor's performance and risk in this R&D context?

The Firm Fixed Price (FFP) contract type places the primary cost risk on the contractor, Advanced Technology International (ATI). This means ATI is obligated to complete the work for the agreed-upon price, regardless of any cost overruns they may encounter during the development of the CBRN mRNA vaccines. For the government, this provides significant cost certainty and predictability. However, in a research and development context, where unforeseen technical challenges and scientific uncertainties are common, an FFP contract can incentivize the contractor to cut corners on quality or scope to manage costs, potentially impacting the final product's efficacy or safety. Conversely, it can also drive efficiency and innovation as the contractor seeks to deliver the required outcomes within the fixed budget. The success of an FFP in R&D often hinges on a very well-defined scope and robust technical understanding upfront.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Biological Product (except Diagnostic) Manufacturing

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: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 315 SIGMA DR, SUMMERVILLE, SC, 29486

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: $19,620,884

Exercised Options: $19,620,884

Current Obligation: $19,620,884

Actual Outlays: $2,150,302

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50123D00003

IDV Type: IDC

Timeline