NIH awards $14.2M for HIV vaccine R&D to Pfizer, highlighting therapeutic vaccine focus

Contract Overview

Contract Amount: $14,238,436 ($14.2M)

Contractor: Pfizer Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2005-09-12

End Date: 2008-08-31

Contract Duration: 1,084 days

Daily Burn Rate: $13.1K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 22

Pricing Type: COST SHARING

Sector: R&D

Official Description: HIV VACCINE DESIGN AND DEVELOPMENT TEAMS, PART B-THERAPEUTIC VACCINES

Place of Performance

Location: COLLEGEVILLE, MONTGOMERY County, PENNSYLVANIA, 19426

State: Pennsylvania Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $14.2 million to PFIZER INC. for work described as: HIV VACCINE DESIGN AND DEVELOPMENT TEAMS, PART B-THERAPEUTIC VACCINES Key points: 1. Contract focuses on early-stage therapeutic vaccine development, a critical but high-risk area. 2. Pfizer Inc. secured the award through full and open competition. 3. The contract duration of over 3 years suggests a complex, multi-phase research effort. 4. Awarded under NAICS code 541710 (R&D in Physical, Engineering, and Life Sciences). 5. Cost-sharing contract type indicates shared financial risk and commitment between government and contractor. 6. The contract's value is modest relative to large-scale vaccine production contracts.

Value Assessment

Rating: good

The contract value of $14.2 million for a 3-year R&D effort appears reasonable for specialized vaccine design and development. Benchmarking against similar early-stage therapeutic vaccine research contracts would provide further context, but the cost-sharing nature suggests a commitment to achieving value. The specific focus on therapeutic vaccines, rather than preventative ones, indicates a targeted investment in a particular area of HIV research.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple qualified bidders had the opportunity to submit proposals. This competitive process is expected to drive fair pricing and innovation. The number of bidders (22) suggests a healthy level of interest and a robust competitive environment for this type of specialized research.

Taxpayer Impact: Full and open competition generally benefits taxpayers by ensuring that the government receives the best possible value through a wide range of proposals and potentially lower prices due to market forces.

Public Impact

The primary beneficiaries are public health initiatives aimed at combating HIV/AIDS through advanced vaccine technology. The contract supports the development of novel therapeutic vaccines designed to treat existing HIV infections. Geographic impact is primarily national, supporting US-based research institutions and pharmaceutical companies. Workforce implications include employment for scientists, researchers, and support staff in the biotechnology and pharmaceutical sectors.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Therapeutic vaccine development is inherently high-risk with uncertain outcomes.
Long development timelines for vaccines can lead to cost overruns if not managed effectively.
Reliance on a single contractor, even with competition, carries some risk if performance falters.

Positive Signals

Awarded through full and open competition, suggesting a competitive selection process.
Cost-sharing arrangement aligns contractor incentives with government objectives.
Focus on a critical public health issue (HIV/AIDS) with potential for significant impact.

Sector Analysis

This contract falls within the Biotechnology and Pharmaceutical Research & Development sector, specifically focusing on vaccine innovation. The market for vaccine R&D is highly specialized, driven by significant investment from both government agencies and private industry. Comparable spending benchmarks would typically involve looking at other NIH grants and contracts for early-stage vaccine research, which can vary widely based on the complexity and novelty of the approach.

Small Business Impact

While this contract was awarded to Pfizer Inc., a large pharmaceutical company, the R&D activities supported may involve subcontracting opportunities for smaller biotech firms or academic institutions specializing in specific research areas. The contract does not appear to be a small business set-aside, but the nature of R&D often fosters collaboration across different sizes of organizations.

Oversight & Accountability

Oversight is likely managed by the National Institutes of Health (NIH) program officials and contracting officers. Accountability measures would include adherence to research milestones, reporting requirements, and financial accountability as stipulated in the cost-sharing agreement. Transparency is generally maintained through public databases of federal contracts, though specific research data may be proprietary.

Related Government Programs

NIH HIV Vaccine Research Programs
Therapeutic Vaccine Development Grants
Biotechnology Research and Development Contracts
Pharmaceutical Innovation Funding

Risk Flags

High scientific risk inherent in vaccine development
Long development timelines
Uncertainty of therapeutic vaccine efficacy

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $14.2 million to PFIZER INC.. HIV VACCINE DESIGN AND DEVELOPMENT TEAMS, PART B-THERAPEUTIC VACCINES

Who is the contractor on this award?

The obligated recipient is PFIZER INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $14.2 million.

What is the period of performance?

Start: 2005-09-12. End: 2008-08-31.

What is the specific scientific approach Pfizer is taking for HIV vaccine design and development under this contract?

This contract, awarded under Part B for therapeutic vaccines, focuses on developing treatments for individuals already infected with HIV, rather than preventative vaccines. While the specific scientific methodologies are proprietary to Pfizer's research, typical approaches in therapeutic vaccine development for HIV include strategies aimed at boosting the immune system's ability to control the virus, potentially through novel antigen design, delivery systems, or combination therapies. The contract likely involves preclinical studies, laboratory research, and potentially early-stage human trials to assess safety and immunogenicity. The cost-sharing nature suggests a significant investment from Pfizer in exploring these advanced therapeutic avenues, indicating a belief in the scientific merit of their proposed approach.

How does the $14.2 million award compare to other HIV vaccine R&D contracts?

The $14.2 million award for HIV vaccine design and development is a moderate sum for a multi-year research project. Large-scale clinical trials for preventative vaccines, especially those involving thousands of participants, can cost hundreds of millions of dollars. However, early-stage research and development, particularly for therapeutic vaccines which target existing infections and may involve more complex biological mechanisms, can range from a few million to tens of millions. This award appears consistent with funding for specialized R&D efforts aimed at exploring novel therapeutic strategies, rather than broad-scale preventative vaccine development or manufacturing.

What are the key performance indicators (KPIs) or milestones expected under this contract?

Key performance indicators and milestones for an HIV vaccine R&D contract typically revolve around scientific progress and adherence to the research plan. These would likely include achieving specific research objectives, such as identifying promising vaccine candidates, demonstrating efficacy in preclinical models (e.g., animal studies), characterizing the immune response generated by the vaccine, and meeting safety profiles. Milestones might also include the successful completion of specific phases of research, timely reporting of results to NIH, and adherence to the budget. Given the cost-sharing nature, Pfizer's own investment milestones would also be critical.

What is Pfizer's track record in vaccine development, particularly for complex diseases like HIV?

Pfizer has a significant and well-established track record in vaccine development, most notably demonstrated by their rapid development and deployment of mRNA COVID-19 vaccines. They also have experience with other vaccines, including those for pneumococcal disease and meningitis. While Pfizer has been involved in HIV research, including collaborations and earlier-stage projects, the development of a successful HIV vaccine has proven exceptionally challenging for the entire scientific community due to the virus's complex nature and ability to evade the immune system. This contract represents a focused effort within their broader R&D portfolio.

What are the potential risks associated with this contract, and how are they being mitigated?

The primary risks associated with this contract are the inherent scientific uncertainty and long timelines associated with vaccine development, particularly for HIV. Therapeutic vaccine development faces additional challenges in demonstrating efficacy in infected individuals. Mitigation strategies include the government's cost-sharing approach, which aligns incentives and shares financial risk, and the requirement for rigorous reporting and milestone achievement. The selection through full and open competition also aims to ensure that a capable contractor with a viable scientific approach was chosen. Continuous monitoring by NIH program officials is crucial for managing risks throughout the contract's duration.

How does this contract contribute to the broader federal strategy for combating HIV/AIDS?

This contract directly supports the federal strategy for combating HIV/AIDS by investing in cutting-edge research for therapeutic vaccines. While preventative vaccines remain a critical goal, therapeutic vaccines offer a complementary approach by aiming to improve treatment outcomes, potentially leading to viral suppression or remission in infected individuals. This aligns with broader public health goals of reducing transmission, improving quality of life for those living with HIV, and ultimately working towards an end to the epidemic. Funding such research demonstrates a commitment to exploring diverse scientific avenues to address the ongoing challenge of HIV.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences

Product/Service Code: RESEARCH AND DEVELOPMENT › Community and Regional Development R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 22

Pricing Type: COST SHARING (T)

Evaluated Preference: NONE

Contractor Details

Parent Company: Pfizer Inc

Address: 33 MOREHALL RD, MALVERN, PA, 19355

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

Financial Breakdown

Contract Ceiling: $40,425,972

Exercised Options: $37,944,044

Current Obligation: $14,238,436

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline