HHS awards $43.8M for Anthrax Vaccine R&D to Emergent Product Development
Contract Overview
Contract Amount: $43,794,113 ($43.8M)
Contractor: Emergent Product Development Gaithersburg Inc.
Awarding Agency: Department of Health and Human Services
Start Date: 2015-03-23
End Date: 2019-07-31
Contract Duration: 1,591 days
Daily Burn Rate: $27.5K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 1
Pricing Type: COST PLUS FIXED FEE
Sector: R&D
Official Description: IGF::OT::IGF FOR OTHER FUNCTIONSTHIS CONTRACT IS FOR THE ADVANCED DEVELOPMENT OF NUTHRAX (ANTHRAX VACCINE ABSORBED WITH CPG 7909) OR AV7909
Place of Performance
Location: GAITHERSBURG, MONTGOMERY County, MARYLAND, 20879
State: Maryland Government Spending
Plain-Language Summary
Department of Health and Human Services obligated $43.8 million to EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. for work described as: IGF::OT::IGF FOR OTHER FUNCTIONSTHIS CONTRACT IS FOR THE ADVANCED DEVELOPMENT OF NUTHRAX (ANTHRAX VACCINE ABSORBED WITH CPG 7909) OR AV7909 Key points: 1. Contract focuses on advanced development of AV7909, an anthrax vaccine. 2. Emergent Product Development is the sole awardee. 3. The contract falls under Research and Development in Biotechnology. 4. Spending is concentrated in Maryland.
Value Assessment
Rating: fair
The contract value of $43.8M for advanced vaccine development appears reasonable given the specialized nature of biopharmaceutical R&D. Benchmarking against similar advanced development contracts for novel vaccines would provide a clearer picture of value.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The contract was awarded under full and open competition, suggesting a competitive process for selecting the contractor. However, the specific awardee is Emergent Product Development, indicating they were the chosen entity from the competitive pool.
Taxpayer Impact: Taxpayer funds are being invested in critical public health preparedness, specifically for a vital vaccine against anthrax.
Public Impact
Enhances national biodefense capabilities against anthrax threats. Supports the development of a potentially life-saving medical countermeasure. Investment in advanced vaccine technology contributes to public health security.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Contract duration is substantial (1591 days).
- Contract type is Cost Plus Fixed Fee, which can lead to cost overruns.
Positive Signals
- Addresses a critical national security and public health need.
- Awarded under full and open competition.
Sector Analysis
This contract falls within the Biotechnology R&D sector, a high-cost, high-risk area focused on scientific innovation. Spending benchmarks for advanced vaccine development can vary significantly based on the stage of research and complexity.
Small Business Impact
The contract was not awarded to a small business. The focus on advanced biopharmaceutical development often involves large, specialized companies with extensive research and manufacturing capabilities.
Oversight & Accountability
The contract is managed by the Department of Health and Human Services, Office of Assistant Secretary for Preparedness and Response, indicating oversight for a critical public health initiative. Further details on specific oversight mechanisms are not provided.
Related Government Programs
- Research and Development in Biotechnology
- Department of Health and Human Services Contracting
- Office of Assistant Secretary for Preparedness and Response Programs
Risk Flags
- Contract duration is long.
- Cost Plus Fixed Fee contract type carries inherent cost risk.
- Sole awardee may limit future competitive options if development is unsuccessful.
- Dependence on a single contractor for a critical vaccine.
Tags
research-and-development-in-biotechnolog, department-of-health-and-human-services, md, definitive-contract, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $43.8 million to EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.. IGF::OT::IGF FOR OTHER FUNCTIONSTHIS CONTRACT IS FOR THE ADVANCED DEVELOPMENT OF NUTHRAX (ANTHRAX VACCINE ABSORBED WITH CPG 7909) OR AV7909
Who is the contractor on this award?
The obligated recipient is EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC..
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 $43.8 million.
What is the period of performance?
Start: 2015-03-23. End: 2019-07-31.
What is the projected efficacy and safety profile of AV7909 based on the advanced development funded by this contract?
The contract focuses on the advanced development of AV7909, implying that initial research has shown promise. However, specific efficacy and safety data would be generated during the development phases funded by this contract. The ultimate success hinges on meeting rigorous FDA approval standards, which requires extensive clinical trials and data analysis to confirm both effectiveness against anthrax and an acceptable safety margin for recipients.
What are the key performance indicators and milestones for Emergent Product Development under this contract to ensure successful vaccine advancement?
Key performance indicators and milestones would likely include successful completion of preclinical studies, progression through Phase I, II, and III clinical trials, demonstration of vaccine stability and manufacturability at scale, and submission of regulatory filings to the FDA. Contractual terms would specify deliverables and timelines for each stage, with payments tied to achieving these predefined objectives to ensure progress and accountability.
How does the cost-plus-fixed-fee structure impact the overall cost-effectiveness of developing AV7909 compared to other contract types?
A Cost-Plus-Fixed-Fee (CPFF) contract allows the contractor to recover all allowable costs plus a fixed fee representing profit. While it incentivizes the contractor to complete the work, it can offer less cost certainty for the government compared to fixed-price contracts, as costs can fluctuate. For complex R&D like vaccine development, CPFF can be appropriate to manage inherent uncertainties, but requires robust government oversight to control costs and ensure value.
Industry Classification
NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in 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
Offers Received: 1
Pricing Type: COST PLUS FIXED FEE (U)
Evaluated Preference: NONE
Contractor Details
Parent Company: Emergent Biosolutions Inc.
Address: 300 PROFESSIONAL DR # 100, GAITHERSBURG, MD, 20879
Business Categories: Category Business, Corporate Entity Not Tax Exempt, Manufacturer of Goods, Not Designated a Small Business, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $43,794,113
Exercised Options: $43,794,113
Current Obligation: $43,794,113
Contract Characteristics
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: YES
Timeline
Start Date: 2015-03-23
Current End Date: 2019-07-31
Potential End Date: 2019-07-31 00:00:00
Last Modified: 2024-09-11
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