Opportunity Information: Apply for PA 18 872
Research to Advance Vaccine Safety (R21 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number: PA-18-872) designed to fund exploratory, early-stage research that strengthens the scientific foundation of vaccine safety. The central aim is to improve understanding of how vaccines and vaccine components interact with the body, what factors may influence uncommon or unexpected outcomes, and how vaccine safety questions can be investigated more rigorously using modern biological and analytical tools. As an R21 mechanism, it is generally geared toward innovative, hypothesis-generating studies or proof-of-concept work rather than large, definitive projects, and it explicitly does not allow clinical trials, meaning applicants must propose non-trial designs such as laboratory studies, computational analyses, secondary data analyses, or observational and methodological work that does not meet the definition of a clinical trial.
The FOA encourages research across several priority areas that NIH considers especially relevant to vaccine safety. One emphasis is on characterizing physiological and immunological responses to vaccines and their components, including the effects of different adjuvants, with the goal of clarifying normal response patterns and identifying biological signatures that might help explain why responses vary across people. A second area focuses on the role of genetic variation in shaping immune or physiological responses that could affect vaccine safety, supporting studies that link host genetics to immune pathways, reactogenicity, or other measurable responses. A third priority is identifying risk factors and biomarkers that may help assess whether certain diseases or disorders have any relationship to licensed vaccines. Examples of risk factors mentioned include prior infection history and a predisposition to, or presence of, allergic or autoimmune disease, along with biological markers that could be used for more precise evaluation of potential associations.
In addition to biological and clinical science questions, the announcement explicitly welcomes quantitative and data-science contributions. This includes developing or evaluating statistical methods for analyzing vaccine safety data, particularly using existing data sources such as passive reporting systems and healthcare databases. Projects might address challenges like confounding, bias, rare-event detection, temporal clustering, signal refinement, or improved causal inference strategies in observational settings. The FOA also highlights the application of genomic and molecular technologies and systems biology approaches, reflecting an interest in integrative methods that combine multi-omics, computational modeling, network analysis, and other high-dimensional approaches to evaluate safety-related mechanisms or patterns.
This opportunity aligns with the goals and objectives of the U.S. National Vaccine Plan, framing vaccine safety research as part of a broader national strategy to maintain and improve public health through vaccination while continuously strengthening safety monitoring and scientific understanding. In practice, this means proposed projects should clearly connect their aims to vaccine safety knowledge gaps, and they should be designed to produce insights, tools, or datasets that can inform future research, surveillance, or policy-relevant questions without conducting interventional clinical trials.
Eligibility is broad. In addition to many standard applicant types (state, county, and local governments; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit entities other than small businesses; and small businesses), the FOA notes additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and certain tribal governments and tribal organizations (including those other than federally recognized). It also allows non-U.S. entities (foreign organizations), which can be important for comparative immunology, global datasets, or methodological collaborations.
Key administrative details from the listing include an original closing date of September 7, 2021, a creation date of July 24, 2018, and CFDA numbers 93.084 and 93.855. The listing does not specify an award ceiling or expected number of awards in the provided text, so applicants typically would confirm current budget limits, project period expectations, and any institute-specific guidance in the full FOA and related NIH policy pages. Overall, the program is best understood as an NIH-backed pathway for innovative, non-clinical-trial research that can sharpen methods, clarify mechanisms, and improve the evidence base used to evaluate and communicate vaccine safety.Apply for PA 18 872
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Research to Advance Vaccine Safety (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.084, 93.855.
- This funding opportunity was created on 2018-07-24.
- Applicants must submit their applications by 2021-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs) - Research to Advance Vaccine Safety (R21 Clinical Trial Not Allowed)
What is the title of this funding opportunity?
The opportunity is titled Research to Advance Vaccine Safety (R21 Clinical Trial Not Allowed).
Which agency is offering this grant opportunity?
This is a discretionary grant opportunity offered by the National Institutes of Health (NIH).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PA-18-872.
What type of NIH award mechanism is this?
This opportunity uses the R21 mechanism, which is generally intended for exploratory, early-stage research, such as innovative, hypothesis-generating studies or proof-of-concept work rather than large, definitive projects.
What is the main purpose or central aim of this FOA?
The central aim is to fund exploratory research that strengthens the scientific foundation of vaccine safety, including improving understanding of how vaccines and vaccine components interact with the body, what factors may influence uncommon or unexpected outcomes, and how vaccine safety questions can be studied more rigorously using modern biological and analytical tools.
Are clinical trials allowed under this FOA?
No. This FOA explicitly states Clinical Trial Not Allowed. Applicants must propose non-trial designs.
If clinical trials are not allowed, what kinds of study designs are appropriate?
Appropriate approaches include laboratory studies, computational analyses, secondary data analyses, and observational and methodological work that does not meet the definition of a clinical trial.
What kinds of research topics does the FOA encourage?
The FOA encourages research that advances vaccine safety science, including biological, clinical science, and quantitative/data-science contributions that improve understanding, methods, or evidence related to vaccine safety.
What are the priority areas highlighted by NIH in this FOA?
The FOA highlights several priority areas, including:
- Characterizing physiological and immunological responses to vaccines and vaccine components
- Studying effects of different adjuvants to clarify response patterns and variability
- Examining how genetic variation influences immune or physiological responses relevant to safety
- Identifying risk factors and biomarkers to assess whether certain diseases or disorders have any relationship to licensed vaccines
- Developing or evaluating statistical and analytical methods for vaccine safety data
- Applying genomic, molecular, and systems biology approaches (including integrative multi-omics and high-dimensional analyses)
Does the FOA include research related to vaccine adjuvants?
Yes. One emphasized area is understanding physiological and immunological responses to vaccines and their components, including the effects of different adjuvants.
Does the FOA support research on why vaccine responses vary between individuals?
Yes. The FOA emphasizes clarifying normal response patterns and identifying biological signatures that may help explain variation in responses across people.
Is host genetics a relevant topic under this FOA?
Yes. A highlighted priority area is the role of genetic variation in shaping immune or physiological responses that could affect vaccine safety, including studies linking host genetics to immune pathways, reactogenicity, or other measurable responses.
What kinds of risk factors are mentioned as examples in the FOA?
Examples mentioned include prior infection history and a predisposition to, or presence of, allergic or autoimmune disease, along with identifying biomarkers that could improve evaluation of potential associations.
Does this opportunity focus only on biological mechanisms, or does it also welcome methods and data science?
It welcomes both. In addition to biological and clinical science questions, the FOA explicitly welcomes quantitative and data-science contributions.
What types of quantitative or statistical work does the FOA encourage?
The FOA encourages developing or evaluating statistical methods for analyzing vaccine safety data, especially using existing data sources such as passive reporting systems and healthcare databases, and addressing challenges like confounding, bias, rare-event detection, temporal clustering, signal refinement, and improved causal inference strategies in observational settings.
Are existing data sources specifically mentioned as acceptable for analysis?
Yes. The FOA points to using existing sources such as passive reporting systems and healthcare databases for vaccine safety analyses.
Does the FOA encourage systems biology or multi-omics approaches?
Yes. The FOA highlights the application of genomic and molecular technologies and systems biology approaches, including integrative methods such as multi-omics, computational modeling, network analysis, and other high-dimensional approaches.
How should proposed projects connect to vaccine safety?
Projects should clearly connect their aims to vaccine safety knowledge gaps and be designed to produce insights, tools, or datasets that can inform future research, surveillance, or policy-relevant questions, without conducting interventional clinical trials.
Does this FOA relate to any broader national strategy or plan?
Yes. The opportunity aligns with the goals and objectives of the U.S. National Vaccine Plan, positioning vaccine safety research as part of a broader national strategy to maintain and improve public health through vaccination while continuously strengthening safety monitoring and scientific understanding.
Who is eligible to apply?
Eligibility is broad and includes many standard applicant types, such as:
- State, county, and local governments
- Public and private institutions of higher education
- Nonprofit organizations (with or without 501(c)(3) status)
- For-profit entities (other than small businesses)
- Small businesses
Are there additional or special categories of eligible applicants listed?
Yes. The FOA also lists additional eligible applicants, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Eligible federal agencies
- Faith-based or community-based organizations
- U.S. territories or possessions
- Regional organizations
- Certain tribal governments and tribal organizations (including those other than federally recognized)
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA allows non-U.S. entities (foreign organizations), which may support comparative immunology work, the use of global datasets, or methodological collaborations.
What are the CFDA numbers associated with this opportunity?
The CFDA numbers listed are 93.084 and 93.855.
When was this opportunity created?
The listing shows a creation date of July 24, 2018.
What is the original closing date listed for this opportunity?
The listing states an original closing date of September 7, 2021.
Does the provided listing specify an award ceiling or the expected number of awards?
No. The provided text does not specify an award ceiling or expected number of awards. Applicants are advised (based on the listing) to confirm current budget limits, project period expectations, and any institute-specific guidance in the full FOA and related NIH policy pages.
What kinds of outcomes or deliverables are implied as valuable under this R21?
Based on the description, valuable outputs include mechanistic insights, improved analytical methods, and tools or datasets that strengthen the evidence base for evaluating and communicating vaccine safety and that can inform future research or surveillance efforts, without conducting clinical trials.
How should applicants interpret "uncommon or unexpected outcomes" in this FOA?
The FOA frames vaccine safety research as improving understanding of factors that may influence uncommon or unexpected outcomes, and encourages using modern biological and analytical tools to investigate these questions more rigorously through non-trial research approaches.
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