NIH invests nearly $20M in R&D for novel anti-opioid vaccines
Contract Overview
Contract Amount: $19,894,862 ($19.9M)
Contractor: Children's Hospital Corporation, the
Awarding Agency: Department of Health and Human Services
Start Date: 2020-09-30
End Date: 2027-09-29
Contract Duration: 2,555 days
Daily Burn Rate: $7.8K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 9
Pricing Type: COST NO FEE
Sector: R&D
Official Description: TO DEVELOP INNOVATIVE AND SAFE MULTIVALENT ANTI-OPIOID VACCINES THAT PROTECT AGAINST HEROIN AND FENTANYL.
Place of Performance
Location: BOSTON, SUFFOLK County, MASSACHUSETTS, 02115
Plain-Language Summary
Department of Health and Human Services obligated $19.9 million to CHILDREN'S HOSPITAL CORPORATION, THE for work described as: TO DEVELOP INNOVATIVE AND SAFE MULTIVALENT ANTI-OPIOID VACCINES THAT PROTECT AGAINST HEROIN AND FENTANYL. Key points: 1. Contract focuses on critical public health need: developing vaccines against heroin and fentanyl. 2. Full and open competition suggests a robust market for this specialized research. 3. Long contract duration (2555 days) indicates a complex, multi-year research and development effort. 4. Research and Development in Biotechnology sector, with a specific focus on vaccine development. 5. Potential for significant public health impact by addressing the opioid crisis.
Value Assessment
Rating: good
The contract value of approximately $19.9 million over roughly 7 years represents a significant investment in a high-priority research area. Benchmarking against similar R&D contracts for vaccine development is challenging due to the specialized nature of anti-opioid vaccines. However, the cost-no-fee contract type suggests that the government is primarily reimbursing the contractor for incurred costs, with the potential for profit tied to achieving specific milestones or overall project success. This structure can incentivize efficient 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 entities had the opportunity to bid. The presence of 9 bids suggests a competitive landscape for this specialized biotechnology research. A competitive process is generally favorable for price discovery and ensuring the government receives the best value for its investment.
Taxpayer Impact: Taxpayers benefit from a competitive process that helps ensure funds are used efficiently for critical research into combating the opioid crisis.
Public Impact
The primary beneficiaries are the public, through the potential development of life-saving vaccines against opioid overdose. Services delivered include research and development of innovative and safe multivalent anti-opioid vaccines. Geographic impact is national, addressing a widespread public health crisis. Workforce implications include support for specialized scientific and research personnel in the biotechnology sector.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Long-term nature of R&D projects carries inherent risks of scientific failure or delays.
- Effectiveness of the developed vaccine will depend on complex biological and clinical outcomes.
Positive Signals
- Focus on a critical public health issue with potential for significant societal benefit.
- Use of full and open competition suggests a well-defined requirement and a competitive market.
- Contract structure (Cost No Fee) aligns incentives for efficient research execution.
Sector Analysis
This contract falls within the Biotechnology (except Nanobiotechnology) sector, a rapidly evolving field focused on leveraging biological systems for research and development. The market for vaccine development is substantial, driven by both public health needs and commercial opportunities. This specific contract addresses a niche but critical area within the broader pharmaceutical and biotechnology landscape, aiming to create novel countermeasures for the ongoing opioid epidemic.
Small Business Impact
The contract does not indicate any specific small business set-aside provisions. Given the specialized nature of advanced vaccine research and development, it is likely that larger, established research institutions or biotechnology firms would be the primary participants in such a competition. Subcontracting opportunities for small businesses may arise in supporting roles, but the primary awardee is unlikely to be a small business.
Oversight & Accountability
Oversight is likely managed by the National Institutes of Health (NIH), a division of the Department of Health and Human Services. The contract type (Cost No Fee) implies that expenditures will be closely monitored to ensure they align with the research objectives. Transparency is expected through regular reporting requirements from the contractor on research progress and expenditures. Inspector General jurisdiction would apply to any potential fraud, waste, or abuse.
Related Government Programs
- National Institute on Drug Abuse (NIDA) research programs
- Centers for Disease Control and Prevention (CDC) opioid overdose prevention initiatives
- Biomedical Advanced Research and Development Authority (BARDA) funding for medical countermeasures
Risk Flags
- Scientific Risk
- Long-term R&D Project
- Potential for Evolving Threats (New Opioid Analogues)
Tags
research-and-development, biotechnology, vaccine-development, opioid-crisis, public-health, department-of-health-and-human-services, national-institutes-of-health, definitive-contract, full-and-open-competition, cost-no-fee, massachusetts, biotechnology-research
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $19.9 million to CHILDREN'S HOSPITAL CORPORATION, THE. TO DEVELOP INNOVATIVE AND SAFE MULTIVALENT ANTI-OPIOID VACCINES THAT PROTECT AGAINST HEROIN AND FENTANYL.
Who is the contractor on this award?
The obligated recipient is CHILDREN'S HOSPITAL CORPORATION, THE.
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 $19.9 million.
What is the period of performance?
Start: 2020-09-30. End: 2027-09-29.
What is the track record of Children's Hospital Corporation in securing federal research grants, particularly in biotechnology and vaccine development?
Children's Hospital Corporation, as a major healthcare and research institution, likely has a history of securing federal research funding. While specific details on their track record for biotechnology and vaccine development grants would require a deeper dive into federal databases like NIH RePORTER or SAM.gov, institutions of this caliber typically have established research programs and a proven ability to manage complex federal awards. Their success in obtaining this contract suggests they possess the necessary expertise, infrastructure, and qualifications to undertake advanced R&D projects. Further analysis would involve examining their portfolio of past awards, publications, and clinical trial involvement in related fields to fully assess their capabilities and experience.
How does the $19.9 million investment compare to other federal funding for opioid-related research or vaccine development?
The $19.9 million investment is a substantial allocation for a specific R&D project focused on anti-opioid vaccines. Federal spending on opioid crisis response is multifaceted, encompassing prevention, treatment, and research. While this contract targets a critical research gap, it represents a portion of the broader federal investment. For context, federal agencies like NIH, NIDA, and CDC collectively allocate billions annually towards various aspects of the opioid crisis, including research into addiction mechanisms, treatment efficacy, and prevention strategies. Funding for vaccine development can vary significantly based on the disease's urgency and scientific feasibility. This particular contract's value suggests a high priority placed on developing novel vaccine countermeasures, reflecting the severity and widespread impact of the opioid epidemic.
What are the primary scientific risks associated with developing multivalent anti-opioid vaccines, and how might they impact project timelines?
Developing multivalent anti-opioid vaccines faces significant scientific risks inherent in novel vaccine design and development. Key challenges include achieving a robust and durable immune response against multiple opioid derivatives (like heroin and fentanyl), ensuring vaccine safety without adverse immunological reactions, and demonstrating efficacy in preventing overdose or addiction. The complexity of opioid molecules as antigens can make it difficult to elicit protective antibodies. Furthermore, the rapid evolution of illicit drug supply chains, with new analogues emerging, poses a challenge for vaccine specificity and longevity. These scientific hurdles can lead to extended research phases, unexpected experimental outcomes, and potential delays in achieving project milestones, impacting the overall contract duration and success probability.
What are the performance metrics or milestones expected for this contract, and how will success be measured?
Performance metrics and milestones for this R&D contract are likely tied to the scientific progression of vaccine development. Expected milestones would typically include preclinical studies demonstrating immunogenicity and safety in animal models, identification of lead vaccine candidates, formulation development, and potentially early-stage human clinical trials (Phase I/II) to assess safety, tolerability, and preliminary immune responses in humans. Success will be measured by the contractor's ability to meet these defined stages within projected timelines and budget constraints. The 'Cost No Fee' structure implies that achieving these milestones is crucial for the contractor to realize any potential profit, aligning their performance directly with the government's objectives for advancing the vaccine candidates.
How has federal spending on biotechnology R&D, specifically for infectious diseases and countermeasures, trended in recent years?
Federal spending on biotechnology R&D, particularly for infectious diseases and countermeasures, has seen a significant upward trend in recent years, accelerated by global health events such as pandemics and ongoing public health crises like the opioid epidemic. Agencies like NIH, BARDA, and DOD consistently increase their investments in areas like vaccine development, antiviral therapies, and diagnostic tools. This trend reflects a strategic focus on strengthening national biodefense capabilities, responding to emerging threats, and addressing persistent health challenges. The rise in funding supports basic research, preclinical development, and clinical trials, fostering innovation within the biotechnology sector and encouraging public-private partnerships to accelerate the translation of scientific discoveries into tangible public health solutions.
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-DAIT-75N93019R009
Offers Received: 9
Pricing Type: COST NO FEE (S)
Evaluated Preference: NONE
Contractor Details
Address: 300 LONGWOOD AVE, BOSTON, MA, 02115
Business Categories: Category Business, Corporate Entity Tax Exempt, Hospital, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $24,785,826
Exercised Options: $19,894,862
Current Obligation: $19,894,862
Actual Outlays: $13,008,533
Contract Characteristics
Multi-Year Contract: Yes
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: YES
Timeline
Start Date: 2020-09-30
Current End Date: 2027-09-29
Potential End Date: 2027-09-29 00:00:00
Last Modified: 2025-06-26
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