HHS awarded $102M for pediatric flu vaccines, with Sanofi Vaccines US Inc. as the sole awardee

Contract Overview

Contract Amount: $101,998,098 ($102.0M)

Contractor: Sanofi Vaccines US Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2013-02-22

End Date: 2014-02-21

Contract Duration: 364 days

Daily Burn Rate: $280.2K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 5

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: PEDIATRIC FLU VACCINE

Place of Performance

Location: SWIFTWATER, MONROE County, PENNSYLVANIA, 18370

State: Pennsylvania Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $102.0 million to SANOFI VACCINES US INC. for work described as: PEDIATRIC FLU VACCINE Key points: 1. The contract represents a significant investment in public health, specifically for pediatric influenza prevention. 2. Competition dynamics for this contract are crucial to assess given the specialized nature of vaccine manufacturing. 3. Performance risk is moderate, given the established nature of flu vaccine production but the critical need for efficacy and safety. 4. This award falls within the broader pharmaceutical and biotechnology sector, a key area for federal health spending. 5. The fixed-price contract structure aims to provide cost certainty for the government. 6. The duration of the contract suggests a sustained need for these vaccine supplies.

Value Assessment

Rating: good

The award of approximately $102 million for pediatric flu vaccines appears to be a substantial but necessary investment in public health. Benchmarking this against other large-scale vaccine procurements would provide further context on its value. The firm fixed-price nature suggests a degree of cost control, but the ultimate value is tied to the efficacy and timely delivery of the vaccines. Without specific comparable contract data for identical pediatric flu vaccines, a precise value-for-money assessment is challenging, but the scale indicates a significant commitment to addressing a critical health need.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple vendors were likely solicited. The presence of 5 bidders suggests a reasonably competitive environment for this specialized pharmaceutical product. A higher number of bidders generally leads to better price discovery and potentially lower costs for the government. However, the specific nature of vaccine production may limit the number of qualified and capable suppliers.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it encourages multiple suppliers to offer their best pricing and terms, potentially leading to cost savings and ensuring the government receives competitive offers for essential medical supplies.

Public Impact

Children across the nation benefit from access to essential influenza vaccinations, contributing to reduced illness and healthcare burdens. The contract ensures the supply of critical pediatric flu vaccines, supporting the Centers for Disease Control and Prevention's immunization programs. The geographic impact is national, aiming to make vaccines available to pediatric populations throughout the United States. This contract supports the pharmaceutical manufacturing workforce involved in vaccine production and distribution.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for supply chain disruptions impacting vaccine availability.
Ensuring consistent vaccine efficacy and safety across batches.
Managing the logistical challenges of distributing vaccines nationwide.

Positive Signals

Award to a known entity in vaccine manufacturing suggests reliability.
Firm fixed-price contract provides cost predictability.
Full and open competition indicates a robust procurement process.

Sector Analysis

The pharmaceutical preparation manufacturing sector is a critical component of the healthcare industry, characterized by high research and development costs, stringent regulatory requirements, and significant government procurement. Federal spending in this area often focuses on essential medicines, vaccines, and medical supplies to support public health initiatives and national security. The market size for vaccines alone is substantial, driven by both routine immunization schedules and pandemic preparedness efforts. This contract fits within the broader federal strategy to ensure adequate supply of critical medical countermeasures.

Small Business Impact

The provided data does not indicate any specific small business set-asides or subcontracting requirements for this contract. Given the specialized nature of pharmaceutical vaccine manufacturing, it is possible that large, established companies are the primary participants. Further analysis would be needed to determine if small businesses have opportunities within the supply chain or in related support services for this contract.

Oversight & Accountability

The Centers for Disease Control and Prevention (CDC) within HHS is responsible for overseeing this contract. Oversight would likely involve monitoring contract performance, ensuring adherence to delivery schedules and quality standards, and managing payments. Transparency is generally maintained through federal procurement databases like FPDS. The Inspector General for HHS would have jurisdiction to investigate any potential fraud, waste, or abuse related to this contract.

Related Government Programs

Pediatric Vaccine Procurement
Influenza Prevention Programs
Public Health Preparedness
Pharmaceutical Manufacturing Contracts
Centers for Disease Control and Prevention Acquisitions

Risk Flags

Potential for supply chain disruption
Ensuring vaccine efficacy and safety
Dependence on a single manufacturer for a critical product

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $102.0 million to SANOFI VACCINES US INC.. PEDIATRIC FLU 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 (Centers for Disease Control and Prevention).

What is the total obligated amount?

The obligated amount is $102.0 million.

What is the period of performance?

Start: 2013-02-22. End: 2014-02-21.

What is the historical spending trend for pediatric flu vaccines by the Department of Health and Human Services?

Analyzing historical spending on pediatric flu vaccines by HHS reveals a consistent and significant commitment to immunization programs. Over the past decade, federal agencies, primarily the CDC, have allocated substantial funds annually to procure influenza vaccines, including specific allocations for pediatric formulations. While exact figures fluctuate based on public health needs, seasonal severity, and market dynamics, spending has generally remained in the tens to hundreds of millions of dollars each year. This sustained investment underscores the ongoing importance of influenza vaccination for child health and the government's role in ensuring supply. Factors influencing year-to-year spending include the number of vaccine doses purchased, the negotiated prices with manufacturers, and any specific public health campaigns or emergency needs that arise.

How does the awarded price per dose compare to market rates for pediatric flu vaccines?

Determining the precise price per dose requires dividing the total contract value ($101,998,097.90) by the number of doses procured, which is not explicitly stated in the provided data. However, if we assume this contract covers a significant portion of the national pediatric flu vaccine supply for a year, the price per dose would likely be competitive within the pharmaceutical industry's established rates. Vaccine pricing is influenced by manufacturing complexity, research and development costs, regulatory compliance, and economies of scale. Federal agencies often leverage their purchasing power through competitive bidding to secure favorable pricing. Comparing this contract's implied per-dose cost to publicly available pricing for similar vaccines or to prices paid by other large purchasers would be necessary for a definitive benchmark. Given the firm fixed-price nature, the government aimed to lock in a specific rate, suggesting a thorough pre-award price analysis.

What are the key performance indicators (KPIs) and quality standards associated with this pediatric flu vaccine contract?

Key performance indicators (KPIs) and quality standards for a pediatric flu vaccine contract would typically revolve around vaccine efficacy, safety, timely delivery, and adherence to storage and handling protocols. The contract likely specifies stringent quality control measures, requiring the manufacturer to meet FDA approval standards and Good Manufacturing Practices (GMP). Performance would be monitored through metrics such as the percentage of vaccine doses meeting purity and potency requirements, the on-time delivery rate to designated distribution points, and the incidence of adverse events reported post-administration. Compliance with temperature control requirements during transport and storage is also critical to maintain vaccine integrity. Failure to meet these KPIs could result in penalties, contract modifications, or termination, highlighting the high stakes involved in ensuring a reliable supply of safe and effective vaccines for children.

What is the track record of Sanofi Vaccines US Inc. in fulfilling federal vaccine contracts?

Sanofi Vaccines US Inc. is a major global pharmaceutical company with a long-standing history and significant expertise in vaccine development and manufacturing. They are a well-established supplier to numerous governments worldwide, including the U.S. federal government, for various vaccines, including influenza vaccines. Their track record with federal contracts is generally robust, characterized by the ability to produce large quantities of vaccines that meet stringent quality and regulatory standards. While specific contract performance details are often proprietary, Sanofi's consistent presence as a key vaccine provider suggests a reliable capacity to meet federal procurement needs. Any past issues or successes would be reflected in federal contract performance databases and agency evaluations, but their overall standing in the vaccine market indicates a strong capability.

What are the potential risks associated with a sole-source or limited competition award for essential vaccines?

While this contract was awarded under full and open competition, the question addresses risks of limited competition. In scenarios with limited or sole-source awards for essential vaccines, the primary risks include higher costs due to reduced price pressure, potential for supply shortages if the single supplier faces production issues, and less incentive for innovation. Taxpayers could face higher prices without competitive bidding. Furthermore, reliance on a single entity can create vulnerabilities in the supply chain, as disruptions at the manufacturer's facility or with their raw material suppliers could have widespread public health consequences. Limited competition can also stifle the entry of new, potentially more advanced or cost-effective vaccine technologies into the market.

How does this contract contribute to national public health preparedness and response capabilities?

This contract significantly bolsters national public health preparedness and response capabilities by ensuring a consistent and adequate supply of pediatric flu vaccines. Influenza remains a persistent public health threat, particularly for young children who are more vulnerable to severe complications. By securing a large quantity of vaccines through a competitive process, the government ensures that healthcare providers have the necessary tools to implement seasonal vaccination campaigns, thereby reducing the incidence and severity of flu-related illnesses, hospitalizations, and deaths. This proactive measure alleviates pressure on the healthcare system and contributes to overall population health resilience. Furthermore, maintaining strong relationships with vaccine manufacturers through such contracts is crucial for rapid response during potential influenza outbreaks or pandemics.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Pharmaceutical Preparation Manufacturing

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 5

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Parent Company: Genzyme Corporation

Address: 1 DISCOVERY DR, SWIFTWATER, PA, 18370

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: $230,821,109

Exercised Options: $230,821,109

Current Obligation: $101,998,098

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Timeline