HHS awards $30.7M for Influenza A seed lot to Seqirus Inc. under full and open competition
Contract Overview
Contract Amount: $30,739,088 ($30.7M)
Contractor: Seqirus Inc
Awarding Agency: Department of Health and Human Services
Start Date: 2022-09-19
End Date: 2025-09-18
Contract Duration: 1,095 days
Daily Burn Rate: $28.1K/day
Competition Type: FULL AND OPEN COMPETITION
Pricing Type: FIRM FIXED PRICE
Sector: Healthcare
Official Description: THE PURPOSE OF THIS TASK ORDER IS TO PROCURE INFLUENZA A/ASTRAKHAN/3212/2020 (H5N8)-LIKE MASTER AND WORKING SEED LOT FOR THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER IDIQ CONTRACT #75A50122D00004 DURING BASE PERIOD YEAR 1.
Place of Performance
Location: HOLLY SPRINGS, WAKE County, NORTH CAROLINA, 27540
Plain-Language Summary
Department of Health and Human Services obligated $30.7 million to SEQIRUS INC for work described as: THE PURPOSE OF THIS TASK ORDER IS TO PROCURE INFLUENZA A/ASTRAKHAN/3212/2020 (H5N8)-LIKE MASTER AND WORKING SEED LOT FOR THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER IDIQ CONTRACT #75A50122D00004 DURING BASE PERIOD YEAR 1. Key points: 1. Procurement of a critical influenza seed lot for HHS. 2. Contract awarded to Seqirus Inc. via full and open competition. 3. Potential risk related to reliance on a single seed lot for a specific influenza strain. 4. Spending falls within the Biological Product Manufacturing sector.
Value Assessment
Rating: good
The contract value of $30.7M for a 3-year period appears reasonable for specialized biological product manufacturing. Benchmarking against similar seed lot procurements would provide further validation.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The contract was awarded under full and open competition, suggesting a competitive bidding process. This method is expected to yield fair pricing and access to qualified vendors.
Taxpayer Impact: Taxpayer funds are used for a critical public health need, ensuring preparedness against influenza outbreaks.
Public Impact
Ensures availability of a master and working seed lot for influenza A/Astrakhan/3212/2020 (H5N8)-like strains. Supports the Department of Health and Human Services' pandemic preparedness and response capabilities. Contributes to the nation's biodefense and public health infrastructure.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Dependence on a single vendor for a critical biological material.
- Potential for supply chain disruptions affecting seed lot availability.
Positive Signals
- Awarded through full and open competition, indicating market responsiveness.
- Addresses a specific and critical public health requirement.
Sector Analysis
This procurement falls under the Biological Product (except Diagnostic) Manufacturing sector, which involves specialized processes and high regulatory standards. Spending benchmarks for similar biological seed lot procurements are not readily available but are typically significant due to R&D and manufacturing complexity.
Small Business Impact
The data does not indicate any specific set-asides for small businesses. The nature of biological seed lot manufacturing often requires specialized facilities and expertise, which may limit small business participation.
Oversight & Accountability
The contract is managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS, a key agency for public health emergencies. Oversight would focus on delivery timelines, quality control, and adherence to contract terms.
Related Government Programs
- Biological Product (except Diagnostic) Manufacturing
- Department of Health and Human Services Contracting
- Office of Assistant Secretary for Preparedness and Response Programs
Risk Flags
- Sole source dependency for a critical biological material.
- Potential for supply chain disruptions.
- Reliance on a specific influenza strain's characteristics.
- Long lead times for developing alternative seed lots if needed.
Tags
biological-product-except-diagnostic-man, department-of-health-and-human-services, nc, delivery-order, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $30.7 million to SEQIRUS INC. THE PURPOSE OF THIS TASK ORDER IS TO PROCURE INFLUENZA A/ASTRAKHAN/3212/2020 (H5N8)-LIKE MASTER AND WORKING SEED LOT FOR THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER IDIQ CONTRACT #75A50122D00004 DURING BASE PERIOD YEAR 1.
Who is the contractor on this award?
The obligated recipient is SEQIRUS 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 $30.7 million.
What is the period of performance?
Start: 2022-09-19. End: 2025-09-18.
What is the specific public health threat posed by the Influenza A/Astrakhan/3212/2020 (H5N8)-like strain that necessitates this procurement?
The Influenza A/Astrakhan/3212/2020 (H5N8)-like strain represents a potential threat due to its high pathogenicity in birds and the possibility of zoonotic transmission to humans, potentially causing severe illness or a pandemic. Procuring a master and working seed lot is crucial for rapid vaccine development and production should an outbreak occur, ensuring national health security.
How does the government ensure the quality and efficacy of the seed lot provided by Seqirus Inc. given its critical role in vaccine production?
The government ensures quality and efficacy through stringent contract specifications, requiring adherence to Good Manufacturing Practices (GMP) and relevant FDA regulations. Regular quality control testing, batch record reviews, and potentially site inspections by HHS or its designated agents would be part of the oversight process to verify the seed lot's identity, purity, potency, and safety before acceptance.
What contingency plans are in place if Seqirus Inc. is unable to fulfill its obligations under this contract, or if the seed lot proves inadequate?
Contingency plans would likely involve identifying alternative suppliers or developing backup seed lots through other means, although this can be time-consuming and costly. The contract may include clauses for termination for default and seeking damages, as well as provisions for the government to procure the supplies from other sources. The existence of multiple influenza strains and ongoing surveillance aims to mitigate risks associated with a single strain's inadequacy.
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: 475 GREEN OAKS PKWY, HOLLY SPRINGS, NC, 27540
Business Categories: Category Business, Corporate Entity Not Tax Exempt, Foreign Owned, Foreign-Owned and U.S.-Incorporated Business, Manufacturer of Goods, Not Designated a Small Business, Special Designations
Financial Breakdown
Contract Ceiling: $30,739,088
Exercised Options: $30,739,088
Current Obligation: $30,739,088
Actual Outlays: $30,627,327
Contract Characteristics
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: NO
Parent Contract
Parent Award PIID: 75A50122D00004
IDV Type: IDC
Timeline
Start Date: 2022-09-19
Current End Date: 2025-09-18
Potential End Date: 2025-09-18 00:00:00
Last Modified: 2026-04-10
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