HHS awards $8.3M contract to Castlevax for next-gen mucosal COVID-19 vaccine development

Contract Overview

Contract Amount: $8,294,985 ($8.3M)

Contractor: Castlevax Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2023-09-30

End Date: 2025-01-31

Contract Duration: 489 days

Daily Burn Rate: $17.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: DEVELOP A NEXT-GENERATION, MUCOSALLY DELIVERED, COVID-19 BOOSTER VACCINE CAPABLE OF ELICITING MUCOSAL IMMUNITY AND PROTECTING AGAINST SARS-COV-2 BREAKTHROUGH INFECTION AND TRANSMISSION

Place of Performance

Location: NEW YORK, NEW YORK County, NEW YORK, 10014

State: New York Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $8.3 million to CASTLEVAX INC for work described as: DEVELOP A NEXT-GENERATION, MUCOSALLY DELIVERED, COVID-19 BOOSTER VACCINE CAPABLE OF ELICITING MUCOSAL IMMUNITY AND PROTECTING AGAINST SARS-COV-2 BREAKTHROUGH INFECTION AND TRANSMISSION Key points: 1. Focus on mucosal immunity for breakthrough infection and transmission protection. 2. Competition method: Full and open, suggesting a broad search for solutions. 3. Risk: Vaccine development is inherently risky, with no guarantee of success. 4. Sector: Biotechnology R&D, a critical area for public health preparedness.

Value Assessment

Rating: questionable

The contract value of $8.3 million for R&D is difficult to benchmark without specific details on the research scope and deliverables. Pricing for novel vaccine development can vary significantly.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

Full and open competition was used, which is ideal for price discovery and ensuring the best value is sought. However, the impact on price for this specific R&D contract is not immediately clear without knowing the number of bids received.

Taxpayer Impact: Taxpayer funds are being invested in potentially groundbreaking vaccine technology, aiming for long-term public health benefits.

Public Impact

Development of a new vaccine delivery method (mucosal) could revolutionize future pandemic responses. Potential to reduce COVID-19 transmission and breakthrough infections, lessening healthcare burden. Investment in domestic biotechnology capabilities, fostering innovation within the US. Success could lead to broader applications for other infectious diseases.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Developmental risk
Uncertainty of efficacy
Long development timelines

Positive Signals

Addresses critical public health need
Utilizes competitive procurement
Focus on novel delivery

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, specifically focusing on vaccine technology. Spending in this area is crucial for national biodefense and public health preparedness, with significant government investment aimed at accelerating innovation.

Small Business Impact

The data indicates this contract was awarded via full and open competition, but does not specify if small businesses were involved or had the opportunity to bid. Further analysis would be needed to determine small business participation.

Oversight & Accountability

The contract is managed by the Department of Health and Human Services, Office of Assistant Secretary for Preparedness and Response, indicating oversight by a relevant agency focused on health security. Accountability will be tied to milestones and deliverables outlined in the definitive contract.

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

Technological uncertainty
Developmental timeline risk
Efficacy and safety validation
Market adoption challenges

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $8.3 million to CASTLEVAX INC. DEVELOP A NEXT-GENERATION, MUCOSALLY DELIVERED, COVID-19 BOOSTER VACCINE CAPABLE OF ELICITING MUCOSAL IMMUNITY AND PROTECTING AGAINST SARS-COV-2 BREAKTHROUGH INFECTION AND TRANSMISSION

Who is the contractor on this award?

The obligated recipient is CASTLEVAX 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 $8.3 million.

What is the period of performance?

Start: 2023-09-30. End: 2025-01-31.

What are the specific performance metrics and milestones for Castlevax Inc. to achieve to be considered successful under this contract?

Success will be measured by Castlevax Inc.'s ability to develop a next-generation, mucoally delivered COVID-19 booster vaccine. Key performance indicators likely include demonstrating the vaccine's capacity to elicit robust mucosal immunity, its efficacy in preventing SARS-CoV-2 breakthrough infections, and its potential to reduce transmission. Specific milestones, such as preclinical study completion, IND submission readiness, and potentially early-stage human trial initiation, would be detailed in the contract's statement of work.

What is the government's contingency plan if Castlevax Inc. fails to meet the developmental or efficacy targets for the vaccine?

The government's contingency plan typically involves contract termination clauses and the potential to re-compete the effort or shift funding to alternative research avenues. If Castlevax fails to meet targets, HHS/ASPR would likely assess the reasons for failure, potentially recouping funds if contract terms were violated. They may then seek other contractors or internal research capabilities to continue pursuing mucosal vaccine technology, leveraging any preliminary data generated.

How does this mucosal vaccine approach compare in terms of projected cost-effectiveness against traditional intramuscular vaccines for long-term COVID-19 management?

The long-term cost-effectiveness of this mucosal vaccine is currently speculative but potentially high if successful. While initial R&D costs are significant, a mucoally delivered vaccine that reduces transmission could lower overall healthcare expenditures by decreasing infection rates, hospitalizations, and the need for repeated booster campaigns. Reduced transmission also lessens societal costs associated with illness. However, manufacturing scalability and long-term durability of mucosal immunity will be key factors in its ultimate cost-benefit analysis.

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

Solicitation ID: BAA-18-100-SOL-00003

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 175 VARICK ST RM 608, NEW YORK, NY, 10014

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

Financial Breakdown

Contract Ceiling: $338,869,093

Exercised Options: $8,294,985

Current Obligation: $8,294,985

Actual Outlays: $8,294,985

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline