HHS awarded $35.9M for H1N1 influenza vaccine, with Sanofi Pasteur as the contractor

Contract Overview

Contract Amount: $35,924,255 ($35.9M)

Contractor: Sanofi Vaccines US Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2006-05-11

End Date: 2011-03-31

Contract Duration: 1,785 days

Daily Burn Rate: $20.1K/day

Competition Type: COMPETITIVE DELIVERY ORDER

Number of Offers Received: 2

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: H5N1 INFLUENZA VACCINE

Place of Performance

Location: SWIFTWATER, MONROE County, PENNSYLVANIA, 18370, UNITED STATES OF AMERICA

State: Pennsylvania Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $35.9 million to SANOFI VACCINES US INC. for work described as: H5N1 INFLUENZA VACCINE Key points: 1. The contract value of $35.9 million for H1N1 influenza vaccine production appears reasonable given the scope of public health preparedness. 2. Competition dynamics for this specific vaccine procurement are not fully detailed, but the delivery order structure suggests it was part of a larger framework. 3. Risk indicators are moderate, primarily related to vaccine efficacy and timely delivery for public health emergencies. 4. Performance context involves ensuring a critical public health supply, with a focus on pandemic response capabilities. 5. Sector positioning is within the biopharmaceutical and public health preparedness sector, a critical area for national security. 6. The contract duration of approximately 5 years (1785 days) indicates a long-term commitment to vaccine availability.

Value Assessment

Rating: good

Benchmarking the value of this specific H1N1 vaccine contract is challenging without direct comparisons for similar pandemic-specific vaccine procurements from the same period. However, the $35.9 million award for a critical public health asset like a pandemic influenza vaccine suggests a potentially good value for money, considering the R&D, manufacturing, and readiness costs involved. The fixed-price nature of the contract provides cost certainty for the government.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded as a competitive delivery order, indicating that the initial award was made under a competitive process, likely a broader indefinite-delivery/indefinite-quantity (IDIQ) contract or a similar competitive vehicle. The presence of 'competitive' in the award type suggests multiple proposals were considered, leading to the selection of Sanofi Pasteur. The number of bidders is not explicitly stated but the competitive nature implies more than one.

Taxpayer Impact: A competitive award process generally leads to better price discovery and potentially lower costs for taxpayers compared to sole-source procurements. It ensures that the government receives competitive offers for essential goods and services.

Public Impact

The primary beneficiaries are the U.S. population, who gain access to a critical vaccine during a public health emergency. The service delivered is the manufacturing and supply of H1N1 influenza vaccine, crucial for pandemic preparedness and response. The geographic impact is national, ensuring vaccine availability across the United States. Workforce implications include supporting jobs in vaccine research, development, manufacturing, and distribution within the biopharmaceutical sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for vaccine efficacy challenges in rapidly evolving viral strains.
Risks associated with manufacturing scale-up and timely delivery during a pandemic.
Dependence on a single contractor for a critical public health supply.

Positive Signals

Contract awarded through a competitive process, suggesting potential for value.
Focus on a critical public health need (pandemic influenza vaccine).
Fixed-price contract provides cost predictability.

Sector Analysis

This contract falls within the biopharmaceutical and life sciences sector, specifically focusing on vaccine manufacturing for public health emergencies. The market for pandemic influenza vaccines is characterized by high R&D costs, stringent regulatory requirements, and significant government investment in preparedness. Comparable spending benchmarks would typically involve other pandemic preparedness contracts or large-scale vaccine procurements, which can vary widely based on the specific pathogen and scale of the threat.

Small Business Impact

Information regarding small business set-asides or subcontracting plans is not explicitly provided in the data. However, given the nature of vaccine manufacturing, it is likely that large pharmaceutical companies are the primary contractors, with potential for smaller specialized firms to be involved in subcontracting roles for specific components or services.

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). Accountability measures would include performance monitoring, adherence to delivery schedules, and quality control of the vaccine. Transparency is generally maintained through contract award databases and public reporting, though specific operational details might be sensitive.

Related Government Programs

HHS Pandemic Preparedness Programs
Influenza Vaccine Procurement
Biodefense and Pandemic Vaccine Contracts
Strategic National Stockpile Acquisitions

Risk Flags

Potential for supply chain disruption.
Vaccine efficacy against evolving strains.
Timeliness of delivery during a public health crisis.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $35.9 million to SANOFI VACCINES US INC.. H5N1 INFLUENZA VACCINE

Who is the contractor on this award?

The obligated recipient is SANOFI VACCINES US 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 $35.9 million.

What is the period of performance?

Start: 2006-05-11. End: 2011-03-31.

What was the specific competitive process used for this delivery order, and how many bids were received?

The data indicates this was a 'COMPETITIVE DELIVERY ORDER' under the 'full-and-open' competition type. This suggests that the delivery order was placed against a pre-existing contract vehicle (like an IDIQ) that was itself awarded through a full and open competitive process. The specific number of bids received for this particular delivery order is not detailed in the provided data. However, the 'competitive' designation implies that multiple sources were solicited or considered, and the award was made based on merit, likely including price and technical factors, rather than being a sole-source award.

How does the $35.9 million contract value compare to other H1N1 vaccine procurements or similar pandemic vaccine contracts?

Directly comparing the $35.9 million award for this H1N1 vaccine contract to other specific H1N1 procurements is difficult without access to historical contract databases detailing similar awards from the same period (2006-2011). However, the value is substantial and reflects the significant investment required for pandemic preparedness. Procurements for pandemic vaccines are inherently costly due to research and development, specialized manufacturing capabilities, and the need for rapid deployment. The price would also be influenced by the quantity ordered, the specific vaccine technology used, and the urgency of the public health threat at the time of the award.

What were the key performance metrics and deliverables expected from Sanofi Pasteur under this contract?

While the specific performance metrics and deliverables are not detailed in the provided summary data, contracts for vaccine manufacturing typically include stringent requirements. Key performance indicators would likely focus on the quality and purity of the vaccine, adherence to Good Manufacturing Practices (GMP), timely production and delivery schedules, and potentially the vaccine's efficacy against the targeted H1N1 strain. Deliverables would include the finished vaccine product, along with associated documentation, quality control data, and potentially cold chain management information to ensure product integrity during transport and storage.

What is the track record of Sanofi Pasteur in fulfilling government vaccine contracts, particularly during public health emergencies?

Sanofi Pasteur, as a major global vaccine manufacturer, has a significant track record of fulfilling government contracts, including those with the U.S. Department of Health and Human Services (HHS) and the Department of Defense. They have been a key supplier for seasonal influenza vaccines and have participated in pandemic preparedness initiatives. Their experience in large-scale vaccine production and distribution, particularly during public health crises like the H1N1 pandemic, suggests a capability to meet government demands. However, like any large-scale manufacturing operation, specific contract performance can vary, and past performance reviews would provide a more detailed assessment.

What are the potential risks associated with relying on a single contractor for a critical vaccine supply like H1N1?

Relying on a single contractor for a critical vaccine supply introduces several risks. These include potential supply chain disruptions due to manufacturing issues, natural disasters affecting the contractor's facilities, or labor disputes. There's also a risk of price increases in future procurements if competition is limited. Furthermore, if the contractor faces unforeseen technical challenges with production or if the vaccine proves less effective than anticipated, the government's ability to respond to a public health emergency could be compromised. Diversifying suppliers or maintaining robust stockpiles are common strategies to mitigate these risks.

How does this contract fit into the broader U.S. strategy for pandemic influenza preparedness?

This contract for H1N1 influenza vaccine is a component of the broader U.S. strategy for pandemic influenza preparedness, likely managed by HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR). Such contracts aim to ensure the availability of vaccines and other medical countermeasures in advance of or during a pandemic. By securing a supply of vaccine, the government can protect the population, maintain essential services, and mitigate the economic and social impacts of a widespread outbreak. This procurement likely contributes to the Strategic National Stockpile or ensures rapid manufacturing capacity.

Industry Classification

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

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

Competition & Pricing

Extent Competed: COMPETITIVE DELIVERY ORDER

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: RFPDHHSORDCVB0513

Offers Received: 2

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Parent Company: Sanofi Pasteur MSD SNC (UEI: 577272925)

Address: 1 DISCOVERY DR, SWIFTWATER, PA, 18370

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Manufacturer of Goods, Not Designated a Small Business

Financial Breakdown

Contract Ceiling: $183,536,870

Exercised Options: $154,436,870

Current Obligation: $35,924,255

Parent Contract

Parent Award PIID: HHSO100200500004I

IDV Type: IDC

Timeline