Opportunity Information: Apply for PA 15 313
Apply for PA 15 313
- The National Institutes of Health in the 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): 93.283 Centers for Disease Control and PreventionInvestigations and Technical Assistance 93.317 Emerging Infections Programs 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 Jul 28, 2015.
- Applicants must submit their applications by Sep 7, 2018. (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: Small businesses City or township governments Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) State governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
Research to Advance Vaccine Safety (R21) (Funding Opportunity Number PA 15 313) was a National Institutes of Health (NIH) discretionary grant opportunity designed to fund early-stage, exploratory research that improves the overall scientific understanding of vaccine safety. The announcement emphasized generating new knowledge, tools, and methods that can clarify how vaccines and vaccine components affect the body, why adverse events may occur in rare cases, and how researchers and public health agencies can better evaluate potential safety signals. The program explicitly aligned with the U.S. National Vaccine Plan, meaning it was positioned as part of a broader federal strategy to strengthen vaccine safety science, monitoring, and public confidence through rigorous evidence.
The FOA encouraged projects across several major scientific themes. One priority area was studying physiological and immunological responses to vaccines and their components, which can include examining immune pathways, inflammatory responses, and other measurable biological changes following vaccination. Another focus was on how genetic variation influences immune or physiological responses that could affect safety outcomes, reflecting interest in host factors that might make certain individuals more susceptible to specific adverse reactions. The announcement also highlighted the need to identify risk factors and biological markers (biomarkers) that could help assess whether there is any relationship between certain diseases or disorders and licensed vaccines. In practice, this could include research aimed at distinguishing coincidence from causality by finding measurable biological signatures, susceptibility profiles, or clinical predictors that can support careful safety assessment.
A substantial methodological component was also encouraged. The FOA welcomed the creation or evaluation of statistical methods for analyzing vaccine safety data, including approaches suited to real-world data and established surveillance resources. Examples referenced in the announcement included passive reporting systems and healthcare databases, which often require specialized analytic strategies to address issues like underreporting, reporting bias, confounding, missing data, and rare outcomes. In addition, the FOA promoted applying genomic and molecular technologies, as well as systems biology approaches, to evaluate vaccine safety. That direction points to integrative studies that combine multi-omics data, high-dimensional immune profiling, and computational modeling to better understand mechanisms, identify potential biomarkers, and improve how safety questions are investigated.
In terms of funding mechanics, this opportunity used the NIH R21 activity code, which is commonly associated with exploratory or developmental projects intended to support innovative ideas, pilot data generation, or proof-of-concept work rather than large, long-term clinical programs. The listed award ceiling was $200,000, and there was no cost sharing or matching requirement. The opportunity was posted on July 28, 2015, with an original and current closing date of September 7, 2018, and it was archived on October 8, 2018, indicating it is no longer open for applications.
Eligibility was broad and included many organization types across the public, private, nonprofit, and academic sectors. Eligible applicants included small businesses; for-profit organizations (including those other than small businesses); nonprofit organizations both with and without 501(c)(3) status; public and private institutions of higher education; and a range of governmental entities (state governments, county governments, city or township governments, special district governments, and independent school districts). The FOA also recognized participation from tribal governments and tribal organizations (including federally recognized tribal governments), public housing authorities/Indian housing authorities, and additional categories such as faith-based or community-based organizations. It further listed eligibility for certain specialized institutions (for example, HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, AANAPISIs, and tribally controlled colleges and universities), U.S. territories or possessions, and even non-U.S. entities (foreign organizations) and regional organizations, reflecting an intent to attract a wide range of capable research teams and settings.
The source information also associated the opportunity with multiple CFDA numbers spanning CDC and NIH-related domains (including allergy and infectious diseases and microbiology/infectious diseases research), reinforcing that the scientific scope overlapped with infectious disease research, immunology, and surveillance/epidemiology. For full details, the FOA provided an NIH Grants Guide link (http://grants.nih.gov/grants/guide/pa-files/PA-15-313.html) and contact support through the NIH Office of Extramural Research (OER) webmaster for access or technical issues.
Frequently Asked Questions (FAQs) - Research to Advance Vaccine Safety (R21) (PA 15 313)
1) What is the Research to Advance Vaccine Safety (R21) funding opportunity (PA 15 313)?
Research to Advance Vaccine Safety (R21) (Funding Opportunity Number PA 15 313) was a National Institutes of Health (NIH) discretionary grant opportunity intended to support early-stage, exploratory research to improve scientific understanding of vaccine safety. It emphasized generating new knowledge, tools, and methods to clarify how vaccines and vaccine components affect the body, why adverse events may occur in rare cases, and how potential vaccine safety signals can be evaluated more effectively.
2) What was the overall goal of this FOA?
The goal was to strengthen vaccine safety science by supporting studies that improve understanding of biological mechanisms, identify potential risk factors or biomarkers related to adverse events, and advance analytic and methodological approaches for assessing vaccine safety using real-world data and surveillance resources.
3) How did this opportunity relate to broader U.S. vaccine policy?
The announcement explicitly aligned with the U.S. National Vaccine Plan. That positioning indicates it was part of a broader federal strategy aimed at strengthening vaccine safety science, monitoring, and public confidence through rigorous evidence.
4) What research topics and themes were encouraged?
The FOA encouraged projects across several major themes, including: (a) physiological and immunological responses to vaccines and vaccine components; (b) the role of genetic variation in influencing immune or physiological responses that could affect safety outcomes; (c) identification of risk factors and biomarkers to help evaluate whether there is a relationship between certain diseases or disorders and licensed vaccines; (d) development or evaluation of statistical methods for analyzing vaccine safety data, especially in real-world settings; and (e) applying genomic, molecular, and systems biology approaches to evaluate vaccine safety.
5) What does it mean that this was an NIH R21?
This opportunity used the NIH R21 activity code, which is commonly associated with exploratory or developmental projects. The R21 mechanism is typically used to support innovative ideas, pilot data generation, and proof-of-concept work rather than large, long-term clinical programs.
6) What kinds of biological responses did the FOA highlight?
The FOA highlighted studying measurable physiological and immunological responses following vaccination. Examples described in the announcement included immune pathways, inflammatory responses, and other biological changes after exposure to vaccines or vaccine components.
7) Did the FOA encourage research on host genetics and susceptibility?
Yes. A specific focus area was how genetic variation influences immune or physiological responses that could affect safety outcomes, reflecting interest in host factors that might make certain individuals more susceptible to specific adverse reactions.
8) What did the FOA mean by identifying risk factors and biomarkers?
The FOA emphasized identifying risk factors and biological markers (biomarkers) that could help assess whether there is any relationship between certain diseases or disorders and licensed vaccines. In practical terms, this could include work aimed at distinguishing coincidence from causality by finding measurable biological signatures, susceptibility profiles, or clinical predictors that support careful safety assessment.
9) Were statistical and data-methods projects in scope?
Yes. The FOA welcomed creating or evaluating statistical methods for analyzing vaccine safety data. It specifically noted approaches suited to real-world data and established surveillance resources, including passive reporting systems and healthcare databases.
10) What data challenges did the FOA highlight for vaccine safety analytics?
The FOA noted that analyzing passive reporting systems and healthcare databases often requires specialized analytic strategies to address issues such as underreporting, reporting bias, confounding, missing data, and rare outcomes.
11) Did the FOA encourage genomic, molecular, and systems biology approaches?
Yes. It promoted applying genomic and molecular technologies and systems biology approaches to evaluate vaccine safety. This direction points to integrative studies that may combine multi-omics data, high-dimensional immune profiling, and computational modeling to better understand mechanisms, identify potential biomarkers, and improve investigation of safety questions.
12) What was the maximum award amount?
The listed award ceiling for this opportunity was $200,000.
13) Was cost sharing or matching required?
No. The opportunity stated there was no cost sharing or matching requirement.
14) When was the opportunity posted and when did it close?
The opportunity was posted on July 28, 2015. The original and current closing date listed was September 7, 2018.
15) Is this funding opportunity still accepting applications?
No. The opportunity was archived on October 8, 2018, which indicates it is no longer open for applications.
16) Who was eligible to apply?
Eligibility was broad and included small businesses; for-profit organizations (including those other than small businesses); nonprofit organizations with or without 501(c)(3) status; public and private institutions of higher education; and multiple levels of government (state, county, city or township, special district governments, and independent school districts). Eligibility also included tribal governments and tribal organizations (including federally recognized tribal governments), public housing authorities/Indian housing authorities, faith-based or community-based organizations, and a variety of specialized institutions (such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, AANAPISIs, and tribally controlled colleges and universities). The FOA also listed U.S. territories or possessions, non-U.S. entities (foreign organizations), and regional organizations as eligible.
17) Were non-U.S. (foreign) organizations eligible?
Yes. The eligibility list included non-U.S. entities (foreign organizations) and regional organizations.
18) What types of government entities were eligible?
The FOA listed state governments, county governments, city or township governments, special district governments, and independent school districts as eligible applicants. It also included tribal governments and tribal organizations, including federally recognized tribal governments.
19) Were faith-based and community-based organizations eligible?
Yes. The FOA explicitly listed faith-based or community-based organizations among eligible applicants.
20) What scientific areas did the associated CFDA numbers suggest?
The source information associated the opportunity with multiple CFDA numbers spanning CDC and NIH-related domains, including areas such as allergy and infectious diseases and microbiology/infectious diseases research. This reinforced that the scientific scope overlapped with infectious disease research, immunology, and surveillance/epidemiology.
21) Where could applicants find the official FOA details?
The FOA provided an NIH Grants Guide link for full details: http://grants.nih.gov/grants/guide/pa-files/PA-15-313.html
22) Who was listed for access or technical support?
The announcement referenced contact support through the NIH Office of Extramural Research (OER) webmaster for access or technical issues.
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