HHS Awards Vaxart $927K for Phase 2B Vaccine Trial Comparing XBB Candidate to mRNA

Contract Overview

Contract Amount: $9,271,191 ($9.3M)

Contractor: Vaxart Biosciences Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2024-01-12

End Date: 2024-10-31

Contract Duration: 293 days

Daily Burn Rate: $31.6K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: CLINICAL TRIAL PLANNING ACTIVITIES FOR A PHASE 2B CLINICAL TRIAL THAT COMPARES VAXART'S XBB VACCINE CANDIDATE TO AN MRNA COMPARATOR TO EVALUATE EFFICACY FOR SYMPTOMATIC AND ASYMPTOMATIC DISEASE, SYSTEMIC AND MUCOSAL IMMUNE INDUCTION, AND ADVERSE

Place of Performance

Location: SOUTH SAN FRANCISCO, SAN MATEO County, CALIFORNIA, 94080

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $9.3 million to VAXART BIOSCIENCES INC for work described as: CLINICAL TRIAL PLANNING ACTIVITIES FOR A PHASE 2B CLINICAL TRIAL THAT COMPARES VAXART'S XBB VACCINE CANDIDATE TO AN MRNA COMPARATOR TO EVALUATE EFFICACY FOR SYMPTOMATIC AND ASYMPTOMATIC DISEASE, SYSTEMIC AND MUCOSAL IMMUNE INDUCTION, AND ADVERSE Key points: 1. The contract focuses on evaluating the efficacy and immune response of Vaxart's XBB vaccine candidate. 2. Competition was full and open, suggesting a competitive bidding process. 3. The award is a definitive contract with a firm fixed price, indicating clear cost expectations. 4. This falls under the Research and Development in Biotechnology sector.

Value Assessment

Rating: fair

The contract value of $927,119 is relatively small for a Phase 2B clinical trial. Benchmarking against similar large-scale clinical trial planning contracts would be necessary to fully assess pricing, but this amount suggests a focused scope or early-stage planning.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, which typically allows for the widest possible range of bidders and can lead to better price discovery. The firm fixed price structure further clarifies cost expectations.

Taxpayer Impact: The taxpayer impact is limited by the relatively small contract value, but the investment aims to advance vaccine development which could have broader public health benefits.

Public Impact

Advancement of a novel vaccine candidate for potential public health use. Supports research into vaccine efficacy against specific COVID-19 variants. Potential for improved vaccine options if the candidate proves successful.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Limited contract value for a Phase 2B trial may indicate a narrow scope or early-stage focus.
Dependence on a single company's vaccine candidate for this specific trial.

Positive Signals

Investment in COVID-19 vaccine research and development.
Utilizes a competitive bidding process for contract award.
Clear pricing structure with a firm fixed price.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, specifically focusing on vaccine development. Spending in this area is crucial for public health preparedness and innovation, with significant government investment often directed towards promising therapeutic and prophylactic candidates.

Small Business Impact

The contract was awarded to Vaxart Biosciences Inc. There is no specific indication in the data provided whether small businesses were involved as subcontractors or partners in this award.

Oversight & Accountability

The Department of Health and Human Services, through the Office of Assistant Secretary for Preparedness and Response, is responsible for overseeing this contract. Standard government oversight mechanisms for contract performance and financial accountability 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

Limited contract value for Phase 2B trial planning.
Potential for scope creep or unforeseen R&D challenges.
Dependence on a single vaccine candidate's success.
Need for further analysis on cost-effectiveness compared to other vaccine development efforts.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $9.3 million to VAXART BIOSCIENCES INC. CLINICAL TRIAL PLANNING ACTIVITIES FOR A PHASE 2B CLINICAL TRIAL THAT COMPARES VAXART'S XBB VACCINE CANDIDATE TO AN MRNA COMPARATOR TO EVALUATE EFFICACY FOR SYMPTOMATIC AND ASYMPTOMATIC DISEASE, SYSTEMIC AND MUCOSAL IMMUNE INDUCTION, AND ADVERSE

Who is the contractor on this award?

The obligated recipient is VAXART BIOSCIENCES 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 $9.3 million.

What is the period of performance?

Start: 2024-01-12. End: 2024-10-31.

What is the specific scope of 'clinical trial planning activities' covered by this contract, and how does it align with the overall cost?

The contract covers planning activities for a Phase 2B trial comparing Vaxart's XBB vaccine candidate against an mRNA comparator. This includes evaluating efficacy for symptomatic and asymptomatic disease, as well as systemic and mucosal immune induction, and adverse events. The $927,119 value suggests this may focus on protocol development, site selection, regulatory submissions preparation, and initial data management planning rather than full-scale trial execution.

Given the full and open competition, what were the key differentiators that led to Vaxart being selected for this specific vaccine trial planning?

While the data confirms full and open competition, the specific differentiators for Vaxart's selection are not detailed. Typically, selection would be based on factors such as the scientific merit of their vaccine candidate, the proposed trial design, the company's demonstrated capability in conducting clinical trials, and potentially the novelty or specific advantages of their platform compared to other potential bidders' proposals.

How does the firm fixed price structure mitigate potential cost overruns for the government in this research and development context?

The firm fixed price (FFP) contract establishes a ceiling price for the defined scope of work, transferring most of the risk for cost overruns to the contractor, Vaxart. This incentivizes efficient performance and cost control. However, in R&D, unforeseen scientific challenges can arise, potentially leading to contract modifications or disputes if the scope needs to change significantly, though the FFP aims to lock in costs for the agreed-upon deliverables.

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: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 170 HARBOR WAY, SOUTH SAN FRANCISCO, CA, 94080

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

Financial Breakdown

Contract Ceiling: $9,271,191

Exercised Options: $9,271,191

Current Obligation: $9,271,191

Actual Outlays: $9,271,191

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline