Opportunity Information: Apply for PA 12 038
Apply for PA 12 038
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Research to Advance Vaccine Safety (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.361 Nursing Research 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jul 28, 2015 and posted on Nov 28, 2011.
- Applicants must submit their applications by Jul 28, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: County governments Special district governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply.Non domestic (non U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The National Institutes of Health (NIH) funding opportunity titled "Research to Advance Vaccine Safety (R21)" (Funding Opportunity Number PA 12-038) supports exploratory, early-stage research meant to strengthen the scientific understanding of vaccine safety. Using the NIH R21 mechanism, the program is geared toward projects that can open new lines of inquiry, pilot emerging approaches, or test novel ideas that may later be expanded in larger studies. The central aim is to generate evidence and tools that help clarify how vaccines and vaccine components interact with human biology, and to improve how potential safety signals are detected, evaluated, and interpreted.
The announcement highlights several priority research directions. One focus is on physiological and immunological responses to vaccines or specific vaccine components, including the kinds of immune pathways or inflammatory processes that may be involved in typical responses and in rarer adverse outcomes. Another priority area is understanding how genetic variation influences immune or physiological responses in ways that could affect vaccine safety, such as differences in immune regulation, susceptibility to particular reactions, or variation in how the body processes vaccine components. The FOA also encourages work to identify risk factors and biological markers that could help assess whether there is a relationship between certain diseases or disorders and licensed vaccines. In practice, that can include developing or validating biomarkers, defining clinical or demographic risk profiles, or studying mechanistic pathways that could plausibly link an exposure to an outcome. In addition, the program welcomes development or evaluation of improved statistical methods for analyzing vaccine safety data, including analyses that use existing data sources such as passive reporting systems, where challenges like underreporting, reporting bias, confounding, and signal detection are common. Finally, it explicitly invites the use of genomic and molecular technologies to advance vaccine safety knowledge, which can include modern "omics" approaches, molecular profiling, or other high-resolution tools that clarify biological responses and heterogeneity across individuals.
Administratively, this is a discretionary grant opportunity under NIH, with activity categories associated with nursing research and infectious disease-related research (CFDA 93.361, 93.855, and 93.856). The listed award ceiling is $200,000. The opportunity does not require cost sharing or matching funds. While the listing includes historical dates (posted November 28, 2011; original closing date January 7, 2015; current closing date July 28, 2015; archived August 28, 2016), the core program description is still useful as a reference point for the kinds of vaccine safety projects NIH has sought to stimulate under the R21 format.
Eligibility is broad and includes many types of domestic and international applicants. Eligible applicants include state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. It also includes public and state-controlled institutions of higher education, private institutions of higher education, small businesses, and for-profit organizations other than small businesses. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, and the eligibility list explicitly includes faith-based and community-based organizations, regional organizations, and multiple categories of minority-serving institutions such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities. The FOA also allows non-U.S. (foreign) institutions to apply, permits non-domestic components of U.S. organizations, and allows foreign components as defined by NIH policy, which signals that NIH was open to expertise and data resources located outside the United States when scientifically justified.
Overall, the opportunity is designed to move vaccine safety science forward on several fronts at once: improving mechanistic understanding of biological responses to vaccination, clarifying why responses differ among individuals (including genetic contributions), strengthening the evidence base around suspected associations by identifying meaningful markers and risk factors, and upgrading the analytical and statistical toolkit used to study vaccine safety signals in real-world data. The full archived announcement and details were provided through the NIH grants guide page listed in the source information.
Frequently Asked Questions (FAQs): NIH "Research to Advance Vaccine Safety (R21)" (PA 12-038)
1) What is this funding opportunity?
This is a National Institutes of Health (NIH) funding opportunity titled "Research to Advance Vaccine Safety (R21)" under Funding Opportunity Number (FON) PA 12-038. It supports exploratory, early-stage research intended to improve scientific understanding of vaccine safety and strengthen how vaccine safety signals are detected, evaluated, and interpreted.
2) What is the main goal of the program?
The central goal is to generate evidence and tools that clarify how vaccines and vaccine components interact with human biology, and to improve methods for identifying and assessing potential safety signals in vaccine safety data.
3) What does the R21 mechanism mean for the type of research supported?
The NIH R21 mechanism is meant for exploratory and early-stage projects. In this program, that includes projects designed to open new lines of inquiry, pilot emerging approaches, or test novel ideas that could later be expanded into larger studies.
4) What kinds of research topics are prioritized?
The announcement highlights several priority directions, including: (a) physiological and immunological responses to vaccines or vaccine components, (b) genetic variation and how it influences vaccine-related responses, (c) identifying risk factors and biological markers relevant to assessing potential relationships between diseases/disorders and licensed vaccines, (d) improved statistical methods for analyzing vaccine safety data (including passive reporting systems), and (e) use of genomic and molecular technologies (including "omics") to advance vaccine safety knowledge.
5) Does the program focus on typical vaccine responses, rare adverse outcomes, or both?
Both. A stated focus is understanding physiological and immunological responses involved in typical responses as well as in rarer adverse outcomes, including immune pathways and inflammatory processes that may be involved.
6) What does the FOA say about studying vaccine components specifically?
It explicitly includes research on responses to vaccines or specific vaccine components, with the intent to clarify which biological pathways are engaged and how those pathways may relate to safety-relevant outcomes.
7) How is genetics addressed in this opportunity?
The FOA encourages research into how genetic variation may influence immune or physiological responses in ways that could affect vaccine safety. Examples described include differences in immune regulation, susceptibility to particular reactions, or variation in how the body processes vaccine components.
8) What does "risk factors and biological markers" mean in this context?
In the context of this FOA, it refers to identifying factors or markers that could help assess whether there is a relationship between certain diseases or disorders and licensed vaccines. The description includes developing or validating biomarkers, defining clinical or demographic risk profiles, and studying mechanistic pathways that could plausibly link an exposure to an outcome.
9) Does the opportunity support work on suspected associations between vaccines and certain conditions?
It supports work to identify risk factors and biological markers that could help assess whether there is a relationship between certain diseases/disorders and licensed vaccines, including mechanistic research and marker development/validation that can strengthen the evidence base around suspected associations.
10) Are methods and statistics projects eligible, or is it only lab/clinical biology?
Methods-focused projects are explicitly encouraged. The FOA welcomes development or evaluation of improved statistical methods for analyzing vaccine safety data, including work that addresses challenges common in real-world and passive reporting data.
11) What kinds of data challenges does the FOA call out for vaccine safety analysis?
For analyses using existing data sources such as passive reporting systems, the FOA notes challenges including underreporting, reporting bias, confounding, and signal detection.
12) Does the FOA encourage using existing data sources?
Yes. It specifically mentions analyses that use existing data sources, including passive reporting systems, and encourages improved statistical approaches suitable for those environments.
13) Are modern genomic or molecular approaches encouraged?
Yes. The FOA explicitly invites the use of genomic and molecular technologies to advance vaccine safety knowledge, including modern "omics" approaches, molecular profiling, and other high-resolution tools to clarify biological responses and heterogeneity across individuals.
14) What NIH activity areas or categories are associated with this opportunity?
Administratively, it is described as a discretionary NIH grant opportunity with activity categories associated with nursing research and infectious disease-related research, and it lists CFDA numbers 93.361, 93.855, and 93.856.
15) What is the maximum award amount mentioned?
The listed award ceiling is $200,000.
16) Is cost sharing or matching required?
No. The opportunity states that it does not require cost sharing or matching funds.
17) Who is eligible to apply?
Eligibility is broad and includes many types of domestic and international applicants. Eligible applicants include various levels of government (state, county, city or township), special district governments, independent school districts, and public housing authorities/Indian housing authorities. It also includes public and state-controlled institutions of higher education, private institutions of higher education, small businesses, and for-profit organizations other than small businesses. Nonprofit organizations are eligible with or without 501(c)(3) status, and the list explicitly includes faith-based and community-based organizations, regional organizations, and multiple categories of minority-serving institutions.
18) Are minority-serving institutions explicitly included?
Yes. The eligibility list explicitly includes multiple categories of minority-serving institutions, including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities.
19) Are faith-based and community-based organizations eligible?
Yes. The eligibility list explicitly includes faith-based and community-based organizations.
20) Can foreign (non-U.S.) institutions apply?
Yes. The FOA allows non-U.S. (foreign) institutions to apply.
21) Are non-domestic components of U.S. organizations allowed?
Yes. It permits non-domestic components of U.S. organizations, and it also allows foreign components as defined by NIH policy.
22) What does the inclusion of foreign components imply?
Based on the description provided, it signals NIH was open to expertise and data resources located outside the United States when scientifically justified.
23) What are the key scientific outcomes NIH is trying to stimulate with this R21?
The opportunity is designed to move vaccine safety science forward by improving mechanistic understanding of biological responses to vaccination, clarifying why responses differ among individuals (including genetic contributions), strengthening evidence around suspected associations via meaningful markers and risk factors, and improving the analytical/statistical toolkit used for vaccine safety signal evaluation in real-world data.
24) Is this opportunity still open?
The listing includes historical dates indicating it is archived (archived August 28, 2016) and shows historical closing dates (original closing date January 7, 2015; current closing date July 28, 2015). Based on those dates, it is presented as a reference point rather than an active competition.
25) Where were full details provided?
The full archived announcement and details were provided through the NIH grants guide page listed in the source information.
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Applicants who have applied for this opportunity (PA 12 038) also looked into and applied for these:
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| Cancer Education Grants Program (R25) Apply for PAR 12 049 Funding Number: PAR 12 049 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Palliative Care and End of Life in People Living with HIV/AIDS(R01) Apply for RFA NR 12 004 Funding Number: RFA NR 12 004 Agency: National Institutes of Health Category: Education Health Funding Amount: $300,000 |
| Palliative Care and End of Life in People Living with HIV/AIDS (R21) Apply for RFA NR 12 005 Funding Number: RFA NR 12 005 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Limited Competition Comprehensive Partnerships to Advance Cancer Health Equity (CPACHE) (U54) Apply for PAR 12 055 Funding Number: PAR 12 055 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
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| NCI Mentored Research Scientist Development Award to Promote Diversity (K01) Apply for PAR 12 050 Funding Number: PAR 12 050 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| NCI Mentored Clinical Scientist Research Career Development Award to Promote Diversity (K08) Apply for PAR 12 051 Funding Number: PAR 12 051 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| NCI Mentored Patient Oriented Research Career Development Award to Promote Diversity (K23) Apply for PAR 12 052 Funding Number: PAR 12 052 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Maternal Nutrition and Pre pregnancy Obesity Effects on Mothers, Infants and Children (R01) Apply for PA 12 061 Funding Number: PA 12 061 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| The NCI Transition Career Development Award to Promote Diversity (K22) Apply for PAR 12 062 Funding Number: PAR 12 062 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Early Stage Innovative Technology Development for Cancer Research (R21) Apply for RFA CA 12 002 Funding Number: RFA CA 12 002 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Validation and Advanced Development of Emerging Technologies for Cancer Research (R33) Apply for RFA CA 12 003 Funding Number: RFA CA 12 003 Agency: National Institutes of Health Category: Education Health Funding Amount: $300,000 |
| Innovative and Early Stage Development of Emerging Technologies in Biospecimen Science (R21) Apply for RFA CA 12 004 Funding Number: RFA CA 12 004 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Validation and Advanced Development of Emerging Technologies in Biospecimen Science (R33) Apply for RFA CA 12 005 Funding Number: RFA CA 12 005 Agency: National Institutes of Health Category: Education Health Funding Amount: $300,000 |
| NCI Established Investigator Award in Cancer Prevention and Control (K05) Apply for PAR 12 065 Funding Number: PAR 12 065 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
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