HHS awarded $136.7M for H1N1 vaccine antigen, with Sanofi Pasteur as the sole awardee

Contract Overview

Contract Amount: $136,650,500 ($136.7M)

Contractor: Sanofi Vaccines US Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2009-09-14

End Date: 2015-09-17

Contract Duration: 2,194 days

Daily Burn Rate: $62.3K/day

Competition Type: COMPETITIVE DELIVERY ORDER

Number of Offers Received: 1

Pricing Type: FIXED PRICE

Sector: Healthcare

Official Description: SANOFI PASTEUR - PURCHASE OF 2009 H1N1 BULK VACCINE ANTIGEN 15UGHA DOSE UNDER CONTRACT HHSO100200800073I (CAN 1994005)

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 $136.7 million to SANOFI VACCINES US INC. for work described as: SANOFI PASTEUR - PURCHASE OF 2009 H1N1 BULK VACCINE ANTIGEN 15UGHA DOSE UNDER CONTRACT HHSO100200800073I (CAN 1994005) Key points: 1. The contract value represents a significant investment in public health preparedness. 2. Competition dynamics for this specific vaccine antigen procurement warrant further examination. 3. The duration of the contract suggests a long-term need for vaccine supply. 4. Performance context is tied to the critical need for pandemic response capabilities. 5. This contract falls within the broader pharmaceutical and biotechnology sector's role in national health security.

Value Assessment

Rating: fair

Benchmarking the value of this specific H1N1 vaccine antigen contract is challenging without comparable procurements for the same product and quantity. The fixed-price nature of the contract provides some cost certainty, but the overall value is contingent on the actual need and deployment of the vaccine. Without more granular data on unit costs or market comparisons for similar bulk vaccine antigens, a definitive value-for-money assessment is difficult.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded as a sole-source procurement, indicating that Sanofi Pasteur was the only identified source capable of fulfilling the requirement. While sole-source awards can be justified in specific circumstances, such as unique capabilities or urgent needs, they limit price discovery and potentially increase costs for the government compared to a competitive process. The lack of competition means that the government did not benefit from multiple vendors bidding to offer the best price and terms.

Taxpayer Impact: The sole-source nature of this award means taxpayers may have paid a premium, as there was no competitive pressure to drive down costs. This highlights the importance of robust justification for sole-source procurements to ensure fair pricing.

Public Impact

The primary beneficiaries are the public, through enhanced preparedness for the H1N1 influenza pandemic. The service delivered is the bulk vaccine antigen, a critical component for manufacturing finished vaccines. The geographic impact is national, ensuring vaccine availability across the United States. Workforce implications include the manufacturing and distribution of vaccine components, supporting jobs in the pharmaceutical sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source award limits competitive pricing and potentially increases cost to taxpayers.
Lack of transparency in the sole-source justification process.
Long contract duration could lead to obsolescence if not managed effectively.
Dependence on a single supplier for a critical public health resource.

Positive Signals

Ensures a critical supply of H1N1 vaccine antigen for public health emergencies.
Award to an established pharmaceutical manufacturer with relevant expertise.
Fixed-price contract provides some cost predictability.
Supports national biodefense and pandemic preparedness initiatives.

Sector Analysis

The pharmaceutical and biotechnology sector is crucial for national health security, providing essential medicines and vaccines. This contract falls within the 'Medicinal and Botanical Manufacturing' industry code. The market for vaccine antigens is highly specialized, often dominated by a few key players due to complex manufacturing processes and regulatory hurdles. Government procurements in this area are typically driven by public health needs and emergency preparedness, rather than routine market demand.

Small Business Impact

This contract does not appear to have a small business set-aside. Given the specialized nature of vaccine antigen manufacturing, it is unlikely that small businesses would be primary contractors for such a large-scale procurement. Subcontracting opportunities for small businesses may exist in supporting roles, but the primary awardee is a large corporation.

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 be tied to the delivery of the specified vaccine antigen according to contract terms. Transparency is limited due to the sole-source nature of the award, but contract award data is publicly available. Inspector General jurisdiction would apply to any allegations of fraud, waste, or abuse.

Related Government Programs

HHS Pandemic Preparedness Contracts
Vaccine Manufacturing and Procurement
Biodefense and National Security
Influenza Preparedness Programs

Risk Flags

Sole-source award
Lack of competitive bidding
Potential for inflated pricing
Dependency on single supplier

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $136.7 million to SANOFI VACCINES US INC.. SANOFI PASTEUR - PURCHASE OF 2009 H1N1 BULK VACCINE ANTIGEN 15UGHA DOSE UNDER CONTRACT HHSO100200800073I (CAN 1994005)

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 $136.7 million.

What is the period of performance?

Start: 2009-09-14. End: 2015-09-17.

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

Sanofi Pasteur, a division of Sanofi-Aventis, has a long history of supplying vaccines to governments worldwide, including the U.S. government. They have been a significant player in influenza vaccine production for many years and have participated in various government programs aimed at stockpiling vaccines for pandemic preparedness. Their track record includes supplying seasonal flu vaccines and responding to specific pandemic threats. While specific details on past performance for similar bulk antigen procurements are not readily available in this summary, their established presence in the vaccine market suggests a capacity to meet large-scale government demands. However, like any large contractor, they may have faced challenges or scrutiny on specific contracts, which would require deeper investigation into individual contract performance reports and any associated corrective actions.

How does the awarded price of $136.7 million for 2009 H1N1 bulk vaccine antigen compare to market rates or similar government procurements?

Direct comparison of the $136.7 million award for 2009 H1N1 bulk vaccine antigen is difficult without specific market data for bulk vaccine antigen pricing during that period or for comparable pandemic response procurements. The contract was awarded on a sole-source basis, which inherently limits price discovery and comparison. Factors influencing the price would include the specific antigen formulation, the manufacturing process, quality control requirements, and the urgency of the need. To assess value, one would need to benchmark against other government contracts for similar bulk vaccine components, if available, or against industry estimates for vaccine manufacturing costs. The absence of competitive bidding makes it challenging to definitively state whether this price represents optimal value for taxpayers.

What are the key risks associated with a sole-source award for a critical public health resource like vaccine antigen?

The primary risk of a sole-source award for critical public health resources like vaccine antigen is the lack of competitive pressure, which can lead to higher prices for the government and taxpayers. It also reduces the incentive for the sole provider to innovate or improve efficiency if they are guaranteed the contract. Furthermore, it creates a dependency on a single supplier, which can be problematic if that supplier experiences production issues, quality control failures, or faces financial instability. This dependency can jeopardize national health security if the supply chain is disrupted. Robust justification and negotiation are crucial to mitigate these risks, ensuring the price is fair and that contingency plans are in place.

What was the specific public health justification for procuring 2009 H1N1 bulk vaccine antigen under this contract?

The contract was awarded in response to the 2009 H1N1 influenza pandemic. The 'bulk vaccine antigen' refers to the core component of the vaccine, which is then processed and formulated into the final injectable product. The justification for this procurement was to ensure a sufficient supply of the H1N1 vaccine to protect the U.S. population against the circulating strain of the virus. This involved building or augmenting the national stockpile of vaccine components to enable rapid manufacturing and distribution of vaccines as needed to combat the pandemic. The procurement aimed to bolster public health preparedness and response capabilities.

How does this contract fit into the broader strategy of the Office of Assistant Secretary for Preparedness and Response (ASPR) for pandemic preparedness?

This contract aligns with the core mission of the Office of Assistant Secretary for Preparedness and Response (ASPR), which is to lead the nation in preparing for, responding to, and recovering from the health impacts of public health emergencies, including pandemics. Procuring critical medical countermeasures like vaccine antigens is a fundamental aspect of ASPR's strategy to build and maintain a robust national stockpile. By securing bulk vaccine antigen, ASPR ensures that the U.S. has the necessary components to rapidly scale up vaccine production and distribution when a pandemic threat emerges, thereby mitigating the health and economic consequences of such events.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Medicinal and Botanical Manufacturing

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

Competition & Pricing

Extent Competed: COMPETITIVE DELIVERY ORDER

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: RFPHHSBARDA0825

Offers Received: 1

Pricing Type: FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

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

Address: 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: $136,650,500

Exercised Options: $136,650,500

Current Obligation: $136,650,500

Contract Characteristics

Multi-Year Contract: Yes

Parent Contract

Parent Award PIID: HHSO100200800073I

IDV Type: IDC

Timeline