HHS awards $29.9M to Protein Sciences Corp for COVID-19 vaccine candidate research

Contract Overview

Contract Amount: $29,925,884 ($29.9M)

Contractor: Protein Sciences Corp

Awarding Agency: Department of Health and Human Services

Start Date: 2020-04-07

End Date: 2020-08-21

Contract Duration: 136 days

Daily Burn Rate: $220.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST SHARING

Sector: Healthcare

Official Description: NON-CLINICAL AND PHASE I CLINICAL STUDIES FOR A STABILIZED PRE-FUSION TRIMER OF THE SPIKE PROTEIN COVID-19 VACCINE CANDIDATE (THE CANDIDATE VACCINE) RECONSTITUTED WITH TWO ADJUVANTS, AS03 AND AF03.

Place of Performance

Location: MERIDEN, NEW HAVEN County, CONNECTICUT, 06450

State: Connecticut Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $29.9 million to PROTEIN SCIENCES CORP for work described as: NON-CLINICAL AND PHASE I CLINICAL STUDIES FOR A STABILIZED PRE-FUSION TRIMER OF THE SPIKE PROTEIN COVID-19 VACCINE CANDIDATE (THE CANDIDATE VACCINE) RECONSTITUTED WITH TWO ADJUVANTS, AS03 AND AF03. Key points: 1. Contract focuses on non-clinical and Phase I studies for a stabilized pre-fusion spike protein COVID-19 vaccine candidate. 2. The award includes reconstitution with two adjuvants, AS03 and AF03, indicating a specific formulation approach. 3. Competition was full and open, suggesting a competitive bidding process for this research and development contract. 4. The sector is Biological Product Manufacturing, crucial for vaccine development and public health preparedness.

Value Assessment

Rating: fair

The award amount of $29.9M for Phase I clinical studies and non-clinical research appears reasonable given the complexity of vaccine development. Benchmarking against similar early-stage vaccine research contracts would provide a clearer picture of value.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, which typically fosters competitive pricing and ensures the government receives the best value. The price discovery mechanism relies on the competitive bids submitted.

Taxpayer Impact: This investment supports the development of a COVID-19 vaccine candidate, aiming to address a critical public health need. Successful development could lead to significant long-term savings by mitigating the economic and social costs of the pandemic.

Public Impact

Accelerates development of a potential COVID-19 vaccine. Supports critical research into vaccine stabilization and adjuvant effectiveness. Enhances national preparedness for future public health emergencies. Potential for broad public health benefits if the vaccine proves effective.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for delays in research timeline.
Uncertainty of vaccine efficacy and safety.
Reliance on specific adjuvant formulations.

Positive Signals

Supports a critical national priority.
Utilizes a competitive procurement process.
Focuses on early-stage research and development.

Sector Analysis

This contract falls within the Biological Product Manufacturing sector, specifically focusing on vaccine research and development. Spending in this sector is highly variable, driven by public health needs and scientific advancements. Benchmarks are difficult without specific therapeutic area data.

Small Business Impact

The contract was awarded to Protein Sciences Corp. Analysis of this company's size and status as a small business is not provided in the data. Further investigation would be needed to determine the impact on small businesses.

Oversight & Accountability

The Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS is responsible for this award, indicating oversight within a dedicated public health preparedness agency. The contract duration and delivery order structure suggest phased oversight.

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

Research and Development Uncertainty
Clinical Trial Risks (Safety/Efficacy)
Adjuvant-Specific Risks
Potential for Timeline Delays
Dependence on Specific Vaccine Platform

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $29.9 million to PROTEIN SCIENCES CORP. NON-CLINICAL AND PHASE I CLINICAL STUDIES FOR A STABILIZED PRE-FUSION TRIMER OF THE SPIKE PROTEIN COVID-19 VACCINE CANDIDATE (THE CANDIDATE VACCINE) RECONSTITUTED WITH TWO ADJUVANTS, AS03 AND AF03.

Who is the contractor on this award?

The obligated recipient is PROTEIN SCIENCES CORP.

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 $29.9 million.

What is the period of performance?

Start: 2020-04-07. End: 2020-08-21.

What is the projected timeline for the completion of these non-clinical and Phase I studies, and what are the key milestones?

The contract period is 136 days, ending August 21, 2020. Key milestones would likely include the completion of non-clinical safety and efficacy testing, as well as the initiation and early data collection from Phase I human trials. Specific detailed milestones are not provided but are crucial for tracking progress and ensuring timely development.

What are the specific risks associated with the chosen adjuvants (AS03 and AF03) in terms of safety and efficacy for this vaccine candidate?

Adjuvants can enhance immune response but also carry risks of local or systemic reactions. AS03 and AF03 have been used in other vaccines, but their specific safety and efficacy profile with this particular spike protein candidate needs rigorous evaluation. Potential risks include injection site reactions, fever, or rare immune-related adverse events that must be carefully monitored in clinical trials.

How will the effectiveness of the vaccine candidate be measured in Phase I trials, and what are the criteria for advancing to subsequent phases?

Phase I trials primarily assess safety and tolerability, along with preliminary immunogenicity (the ability to provoke an immune response). Effectiveness is not the primary endpoint. Measurements would include antibody titers and T-cell responses. Criteria for advancing typically involve demonstrating an acceptable safety profile and evidence of a robust immune response, paving the way for larger efficacy-focused Phase II and III trials.

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

Offers Received: 1

Pricing Type: COST SHARING (T)

Evaluated Preference: NONE

Contractor Details

Parent Company: Sanofi

Address: 1000 RESEARCH PKWY, MERIDEN, CT, 06450

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

Financial Breakdown

Contract Ceiling: $29,925,884

Exercised Options: $29,925,884

Current Obligation: $29,925,884

Actual Outlays: $29,925,884

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: HHSO100201600005I

IDV Type: IDC

Timeline