HHS awarded $29.8M for vaccine development, but competition was limited

Contract Overview

Contract Amount: $29,800,000 ($29.8M)

Contractor: Sanofi Pasteur Biologics, LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2006-09-22

End Date: 2012-04-26

Contract Duration: 2,043 days

Daily Burn Rate: $14.6K/day

Competition Type: NOT COMPETED

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: TAS::75 0943::TAS ACAMBIS, 200-2002-00004

Place of Performance

Location: ATLANTA, DEKALB County, GEORGIA, 30329

State: Georgia Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $29.8 million to SANOFI PASTEUR BIOLOGICS, LLC for work described as: TAS::75 0943::TAS ACAMBIS, 200-2002-00004 Key points: 1. The contract value represents a significant investment in vaccine research and development. 2. Limited competition raises questions about potential price overruns and value for money. 3. The contract duration of over 5 years suggests a long-term commitment to the project. 4. The firm fixed-price contract type offers some cost certainty, but flexibility may be limited. 5. The award was made to a single entity, indicating a lack of broader market engagement. 6. The contract's performance period spans a considerable timeframe, requiring sustained oversight.

Value Assessment

Rating: fair

The contract value of $29.8 million for vaccine development is substantial. Without comparable contracts or detailed cost breakdowns, it is difficult to definitively benchmark the value for money. However, the lack of competition suggests that the government may not have achieved the most competitive pricing. Further analysis would be needed to compare the per-unit cost of the vaccine doses or research outcomes against market rates or similar government procurements.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded on a sole-source basis, meaning it was not competed among multiple vendors. This approach is typically used when only one vendor possesses the unique capability or technology required for the procurement. The lack of competition means that the government did not benefit from the price discovery mechanisms that typically occur in a competitive bidding process, potentially leading to higher costs.

Taxpayer Impact: Taxpayers may have paid a premium due to the absence of competitive pressure to lower prices. The government missed an opportunity to explore alternative solutions or innovations from a wider range of potential suppliers.

Public Impact

The primary beneficiaries are likely public health initiatives focused on vaccine development and disease prevention. The services delivered are critical for advancing medical countermeasures and ensuring national health security. The geographic impact is national, with potential global implications for disease control. Workforce implications include support for specialized scientific and research roles within the contractor's organization and potentially related industries.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source award limits price negotiation and potential for innovation from other vendors.
Long contract duration could lead to scope creep or cost overruns if not managed tightly.
Lack of transparency in the sole-source justification requires scrutiny.
Performance metrics and deliverables need rigorous monitoring to ensure value.
Potential for vendor lock-in due to specialized nature of vaccine development.

Positive Signals

Focus on critical public health need (vaccine development).
Firm fixed-price contract provides some cost predictability.
Award to a known entity in the biopharmaceutical sector.
Long-term commitment suggests strategic importance of the project.
Potential for significant advancements in public health outcomes.

Sector Analysis

This contract falls within the Biotechnology and Pharmaceuticals sector, a critical area for national health security and economic growth. The market is characterized by high R&D costs, long development cycles, and significant regulatory hurdles. Government spending in this sector often supports early-stage research, advanced development, and procurement of essential medical countermeasures. Comparable spending benchmarks would typically involve analyzing other government contracts for vaccine development, pharmaceutical research, and biodefense initiatives.

Small Business Impact

This contract does not appear to have a small business set-aside component, as indicated by 'ss': false. There is no explicit information regarding subcontracting plans for small businesses. The sole-source nature of the award further limits opportunities for small businesses to participate directly or indirectly through subcontracting. This could mean a missed opportunity to foster innovation and capacity within the small business ecosystem in the biopharmaceutical research and development space.

Oversight & Accountability

Oversight mechanisms for this contract would primarily reside with the Centers for Disease Control and Prevention (CDC) within HHS. Accountability measures would be tied to the contract's performance work statement, milestones, and deliverables. Transparency is limited due to the sole-source nature of the award, but contract modifications and performance reports should be accessible through federal procurement databases. The Inspector General of HHS would have jurisdiction to investigate any potential fraud, waste, or abuse related to this contract.

Related Government Programs

Biomedical Advanced Research and Development Authority (BARDA) contracts
National Institutes of Health (NIH) research grants
Department of Defense (DoD) biodefense procurements
Strategic National Stockpile acquisitions

Risk Flags

Sole-source award lacks competitive pricing pressure.
Potential for cost overruns due to long duration and R&D complexity.
Limited transparency in procurement process.
Dependency on a single contractor for critical development.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $29.8 million to SANOFI PASTEUR BIOLOGICS, LLC. TAS::75 0943::TAS ACAMBIS, 200-2002-00004

Who is the contractor on this award?

The obligated recipient is SANOFI PASTEUR BIOLOGICS, LLC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Centers for Disease Control and Prevention).

What is the total obligated amount?

The obligated amount is $29.8 million.

What is the period of performance?

Start: 2006-09-22. End: 2012-04-26.

What specific vaccine or medical countermeasure was this contract intended to develop?

The provided data does not specify the exact vaccine or medical countermeasure. However, given the awarding agency (HHS) and the context of vaccine development, it likely pertains to a critical public health need, potentially related to infectious diseases or biodefense. Further investigation into the contract details, such as the Statement of Work or specific task orders, would be necessary to identify the precise objective. The contract number '200-2002-00004' might be a key identifier for retrieving more granular information from federal procurement databases.

What is the track record of Sanofi Pasteur Biologics, LLC in fulfilling government contracts for vaccine development?

Sanofi Pasteur Biologics, LLC is a well-established entity in the biopharmaceutical industry with a history of developing and manufacturing vaccines. While specific performance data for this particular contract is not detailed here, the company has been a significant player in both commercial and government vaccine markets globally. Assessing their track record would involve reviewing past contract performance evaluations (e.g., Contractor Performance Assessment Reporting System - CPARS), any past performance issues or awards, and their success rate in bringing vaccine candidates through development and regulatory approval stages for government agencies like HHS or the Department of Defense.

How does the $29.8 million award compare to typical R&D costs for vaccine development?

The $29.8 million award is a substantial sum, but the typical R&D costs for vaccine development can vary enormously, ranging from tens of millions to hundreds of millions of dollars, or even billions for complex projects. Factors influencing cost include the type of vaccine (e.g., mRNA, viral vector, subunit), the target disease, the stage of development (pre-clinical, Phase I, II, III trials), and the required manufacturing scale-up. Without knowing the specific vaccine target and development phase, it's challenging to definitively benchmark this award. However, for a significant phase of development or a novel vaccine candidate, this amount could be considered within a reasonable range, especially considering the high failure rate in drug development.

What are the risks associated with a sole-source award for vaccine development?

Sole-source awards in vaccine development carry several risks. Firstly, the lack of competition can lead to higher prices than might be achieved through a competitive process, impacting the overall value for taxpayer money. Secondly, it limits the government's exposure to potentially innovative approaches or alternative technologies that other companies might offer. Thirdly, it can create a dependency on a single contractor, which could be problematic if the contractor faces production issues, financial instability, or strategic shifts. Finally, the justification for a sole-source award needs to be robust to ensure that competition was genuinely not feasible or advantageous.

What oversight mechanisms are in place to ensure the successful development and delivery of the vaccine?

Oversight for this contract would typically involve a multi-faceted approach. The Contracting Officer's Representative (COR) or Technical Point of Contact (TPOC) would be responsible for day-to-day monitoring of performance, adherence to the Statement of Work, and technical progress. Regular progress reports, milestone reviews, and potentially site visits would be employed to track development. Financial oversight would ensure that funds are disbursed according to contract terms and performance. Given the critical nature of vaccine development, additional oversight might come from program managers within HHS and potentially from scientific advisory boards. The contract's firm fixed-price nature also implies that the contractor bears more risk for cost overruns, incentivizing efficient project management.

How has federal spending on vaccine development evolved over the past decade?

Federal spending on vaccine development has generally seen an upward trend over the past decade, driven by increasing awareness of global health security threats, the need for countermeasures against emerging infectious diseases (like COVID-19), and advancements in vaccine technology. Agencies like HHS (through CDC, NIH, BARDA) and the Department of Defense consistently invest in R&D for vaccines. Spending fluctuates based on specific public health emergencies, national security priorities, and the pipeline of promising research. The COVID-19 pandemic significantly accelerated federal investment in vaccine research, development, and manufacturing capacity, highlighting the strategic importance of this area.

Competition & Pricing

Extent Competed: NOT COMPETED

Solicitation Procedures: ONLY ONE SOURCE

Solicitation ID: 2002N00004

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Parent Company: Sanofi Pasteur Vaxdesign Corp (UEI: 739980787)

Address: 38 SIDNEY ST, CAMBRIDGE, MA, 02139

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: $59,600,000

Exercised Options: $29,800,000

Current Obligation: $29,800,000

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Parent Contract

Parent Award PIID: HHSD200200200004I

IDV Type: IDC

Timeline