HHS Awards $10M Contract to Codagenix for COVID-19 Vaccine Efficacy Study

Contract Overview

Contract Amount: $10,000,000 ($10.0M)

Contractor: Codagenix Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2023-09-30

End Date: 2025-06-30

Contract Duration: 639 days

Daily Burn Rate: $15.6K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: CONDUCT A PHASE 2B EFFICACY STUDY AS PRESCRIBED IN AOI15 WITH COVILIV A PROPRIETARY LIVE ATTENUATED VIRUS COVID-19 VACCINE.

Place of Performance

Location: FARMINGDALE, SUFFOLK County, NEW YORK, 11735

State: New York Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $10.0 million to CODAGENIX INC for work described as: CONDUCT A PHASE 2B EFFICACY STUDY AS PRESCRIBED IN AOI15 WITH COVILIV A PROPRIETARY LIVE ATTENUATED VIRUS COVID-19 VACCINE. Key points: 1. The contract supports a Phase 2B efficacy study for Codagenix's proprietary live-attenuated virus COVID-19 vaccine. 2. This award falls under the Research and Development in Biotechnology sector, specifically focusing on vaccine development. 3. The contract's value of $10 million is a significant investment in advancing this specific vaccine candidate. 4. Competition was full and open, suggesting a competitive bidding process for this research and development effort.

Value Assessment

Rating: fair

The contract value of $10 million for a Phase 2B efficacy study appears reasonable for the scope of work. Benchmarking against similar vaccine development contracts is difficult without more detailed cost breakdowns, but the amount is within a typical range for late-stage clinical trials.

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 had the opportunity to bid. This method generally promotes competitive pricing and ensures the government receives the best value. The price discovery process likely involved comparing proposals based on technical merit and cost.

Taxpayer Impact: Taxpayer funds are being used to advance vaccine research, potentially leading to a new public health tool. The investment aims for a return in the form of a viable vaccine, but the ultimate taxpayer impact depends on the study's success and subsequent market adoption.

Public Impact

Potential for a new COVID-19 vaccine option. Investment in biotechnology and pandemic preparedness. Support for scientific research and development in New York. Government funding for critical public health initiatives.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Vaccine efficacy is not guaranteed and may not meet study endpoints.
Regulatory approval processes can be lengthy and uncertain.
Market adoption of a new vaccine faces competition from existing options.

Positive Signals

Focus on a novel vaccine platform (live-attenuated virus).
Awarded under full and open competition.
Supports critical public health research.

Sector Analysis

This contract falls within the Biotechnology (except Nanobiotechnology) R&D sector. Spending in this area is crucial for developing new medical countermeasures and addressing public health threats. Benchmarks for Phase 2B vaccine studies vary widely based on disease, vaccine type, and trial complexity.

Small Business Impact

The contract was awarded to Codagenix Inc., a specific company, and there is no indication of subcontracting opportunities for small businesses within the provided data. Further analysis would be needed to determine if small businesses are involved in the supply chain or research process.

Oversight & Accountability

The Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response, is responsible for overseeing this contract. Standard government oversight mechanisms for research and development contracts, including progress reports and financial reviews, would apply.

Related Government Programs

Research and Development in Biotechnology (except Nanobiotechnology)
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Uncertainty of vaccine efficacy and market acceptance.
Potential for delays in clinical trial timelines.
Dependence on regulatory approval processes.
Competition from established COVID-19 vaccines.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $10.0 million to CODAGENIX INC. CONDUCT A PHASE 2B EFFICACY STUDY AS PRESCRIBED IN AOI15 WITH COVILIV A PROPRIETARY LIVE ATTENUATED VIRUS COVID-19 VACCINE.

Who is the contractor on this award?

The obligated recipient is CODAGENIX 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 $10.0 million.

What is the period of performance?

Start: 2023-09-30. End: 2025-06-30.

What is the projected timeline for the completion of the Phase 2B study and potential for subsequent phases?

The contract has an estimated completion date of June 30, 2025, suggesting the Phase 2B study is expected to conclude around this time. However, the duration of clinical trials can be subject to change based on recruitment rates, data analysis, and unforeseen circumstances. Successful completion of Phase 2B would typically lead to planning for Phase 3 trials, which are necessary for regulatory approval.

What are the key efficacy endpoints for this Phase 2B study, and what are the acceptable thresholds for success?

The specific efficacy endpoints and success thresholds for the Phase 2B study are not detailed in the provided contract data. These critical details are typically outlined in the study protocol agreed upon by the sponsor (Codagenix) and regulatory agencies. They would likely involve measures of immune response (e.g., antibody levels, T-cell responses) and potentially preliminary assessments of protection against infection or disease.

How does the cost-plus-fixed-fee contract structure incentivize Codagenix to manage costs effectively during the research?

A Cost Plus Fixed Fee (CPFF) contract covers allowable costs incurred by the contractor plus a fixed fee representing profit. While the fixed fee provides an incentive for the contractor to complete the work, it doesn't directly reward cost savings as much as other contract types like fixed-price incentives. Oversight is crucial to ensure costs remain reasonable and allocable to the contract objectives.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 3 BIOSCIENCE PARK DR, FARMINGDALE, NY, 11735

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

Financial Breakdown

Contract Ceiling: $389,449,173

Exercised Options: $57,630,647

Current Obligation: $10,000,000

Actual Outlays: $6,794,012

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline