HHS Awards $18.16M for Vaccine Clinical Study to GlaxoSmithKline, LLC

Contract Overview

Contract Amount: $18,161,554 ($18.2M)

Contractor: Glaxosmithkline, LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2019-08-28

End Date: 2024-04-29

Contract Duration: 1,706 days

Daily Burn Rate: $10.6K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: AS03B-H7N9 VACCINE CLINICAL STUDY

Place of Performance

Location: DURHAM, DURHAM County, NORTH CAROLINA, 27709

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $18.2 million to GLAXOSMITHKLINE, LLC for work described as: AS03B-H7N9 VACCINE CLINICAL STUDY Key points: 1. Contract awarded to GlaxoSmithKline, LLC for a vaccine clinical study. 2. The contract value is $18.16 million. 3. The award was made under full and open competition. 4. The study is for Biological Product Manufacturing. 5. The contract duration is 1706 days.

Value Assessment

Rating: good

The contract value of $18.16 million for a multi-year clinical study appears reasonable given the scope and duration. Benchmarking against similar large-scale clinical trial contracts would provide a more precise assessment.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting a robust price discovery process. This method typically leads to competitive pricing as multiple vendors have the opportunity to bid.

Taxpayer Impact: Full and open competition generally ensures taxpayer funds are used efficiently by fostering a competitive environment that drives down costs.

Public Impact

Supports critical public health research for vaccine development. Ensures availability of essential medical countermeasures. Contributes to national biodefense and pandemic preparedness. Potential for improved public health outcomes through advanced medical research.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns in long-term clinical studies.
Dependence on a single contractor for a critical study.

Positive Signals

Awarded through full and open competition.
Supports a vital area of public health.
Long contract duration allows for comprehensive study.

Sector Analysis

This contract falls within the healthcare sector, specifically in biological product manufacturing and clinical research. Spending in this area is crucial for public health initiatives and pandemic preparedness, with significant government investment often seen in vaccine development and testing.

Small Business Impact

The data does not indicate any specific involvement or set-aside for small businesses in this contract. Large pharmaceutical companies typically dominate this segment of the market.

Oversight & Accountability

The contract is managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS, an agency responsible for leading medical preparedness and response efforts. Oversight would focus on study progress, adherence to protocols, and financial management.

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

Long contract duration may increase risk of scope creep or changing requirements.
Potential for cost escalation over the 1706-day period.
Reliance on a single vendor for a critical research component.
Clinical trial outcomes are inherently uncertain.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $18.2 million to GLAXOSMITHKLINE, LLC. AS03B-H7N9 VACCINE CLINICAL STUDY

Who is the contractor on this award?

The obligated recipient is GLAXOSMITHKLINE, LLC.

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 $18.2 million.

What is the period of performance?

Start: 2019-08-28. End: 2024-04-29.

What specific vaccine is being studied and what is its potential impact?

The specific vaccine is not detailed in the provided data. However, clinical studies are essential for evaluating the safety and efficacy of new vaccines. Successful outcomes could lead to improved public health, disease prevention, and enhanced national biodefense capabilities, potentially reducing the burden of infectious diseases.

Are there any identified risks associated with the contractor's performance or the study's outcome?

While the data doesn't list specific risks, potential concerns in clinical studies include delays in recruitment, unexpected adverse events, or failure to meet efficacy endpoints. The long duration also presents a risk of changing scientific landscapes or funding priorities impacting the study's ultimate value.

How does this spending align with broader federal health and preparedness goals?

This spending directly aligns with federal goals for public health preparedness and response, particularly concerning infectious diseases and biodefense. Investing in vaccine clinical studies is a proactive measure to ensure the nation has effective countermeasures against current and emerging health threats.

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: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: 15100SOL00003

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 5 MOORE DR, RESEARCH TRIANGLE PARK, NC, 27709

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Limited Liability Corporation, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $18,161,554

Exercised Options: $18,161,554

Current Obligation: $18,161,554

Actual Outlays: $11,764,678

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: HHSO100201600004I

IDV Type: IDC

Timeline