Opportunity Information: Apply for PA 15 312
Apply for PA 15 312
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Research to Advance Vaccine Safety (R01)" 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.)
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities County governments Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) City or township governments 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 (R01) is a National Institutes of Health (NIH) grant funding opportunity (Funding Opportunity Number PA-15-312) designed to support research that strengthens the scientific understanding of vaccine safety. The announcement focuses on building better evidence and better tools for evaluating safety questions around licensed vaccines and vaccine components. In practical terms, it is meant to fund studies that clarify how vaccines interact with the human body, why adverse responses might occur in some people, and how researchers and public health agencies can more accurately detect, measure, and interpret potential safety signals. The work supported under this opportunity is explicitly aligned with the U.S. National Vaccine Plan, meaning it is framed to advance national priorities for vaccine confidence, monitoring, and safety science.
The FOA highlights several major research directions. One priority area is studying physiological and immunological responses to vaccines and their components. This can include basic and translational research on immune activation, inflammation, reactogenicity, and other biological responses that occur after vaccination, with the goal of distinguishing normal immune responses from responses that could plausibly contribute to clinically meaningful adverse events. Another priority is understanding how genetic variation influences immune or physiological responses in ways that may affect vaccine safety. That includes research on host genetics, gene-environment interactions, and differential responses across populations that could help explain why a rare event might occur in a small subset of vaccine recipients.
A third emphasized area is identifying risk factors and biological markers that could be used to assess whether there is a relationship between certain diseases or disorders and licensed vaccines. This is about improving the ability to evaluate causality or lack of causality by finding measurable indicators (for example, biomarkers, immunologic profiles, or clinical predictors) that can help characterize susceptibility, timing, and mechanism. The FOA also encourages methodological work, especially the creation or evaluation of statistical methods for analyzing vaccine safety data. This includes approaches applicable to real-world data streams such as passive reporting systems and healthcare databases, which often have limitations like under-reporting, confounding, missing data, and reporting biases. Methods development in this space might involve new signal-detection techniques, better causal inference strategies, improved study designs for observational data, and validation techniques to ensure findings are robust and reproducible.
In addition, the FOA calls for the application of modern genomic and molecular technologies and systems biology approaches to vaccine safety questions. This can cover high-throughput genomics, transcriptomics, proteomics, metabolomics, and integrative systems analyses aimed at mapping pathways associated with adverse events or identifying biological signatures of risk. Overall, the scientific theme is not limited to any single vaccine or adverse event; it is broadly focused on improving the science, data, and analytic frameworks used to evaluate vaccine safety.
Administratively, this opportunity uses the R01 mechanism, which is NIH's standard research project grant. It is categorized as a discretionary grant in the health area. The FOA was posted and created on July 28, 2015, with an original and current closing date of September 7, 2018, and it was archived on October 8, 2018. It is associated with multiple CFDA numbers reflecting overlapping public health and infectious disease research areas: 93.283 (CDC Investigations and Technical Assistance), 93.317 (Emerging Infections Programs), 93.855 (Allergy and Infectious Diseases Research), and 93.856 (Microbiology and Infectious Diseases Research). The announcement states there is no cost sharing or matching requirement.
Eligibility is broad and includes many organization types across the public, nonprofit, academic, and private sectors. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (with the noted exception categories described in the FOA); small businesses; and for-profit organizations other than small businesses. It also explicitly includes a wide range of mission- and community-based institutions and entities such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Tribally Controlled Colleges and Universities (TCCUs), Native American tribal governments (federally recognized and other than federally recognized), U.S. territories or possessions, faith-based or community-based organizations, eligible federal agencies, regional organizations, and non-U.S. entities (foreign organizations).
For applicants or readers seeking the full official announcement and requirements, the FOA points to the NIH grants page at http://grants.nih.gov/grants/guide/pa-files/PA-15-312.html. For access or linking issues, the contact provided is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs) - Research to Advance Vaccine Safety (R01) (PA-15-312)
1. What is the "Research to Advance Vaccine Safety (R01)" funding opportunity?
Research to Advance Vaccine Safety (R01) is a National Institutes of Health (NIH) grant funding opportunity (Funding Opportunity Number PA-15-312) intended to support research that strengthens the scientific understanding of vaccine safety. It focuses on building stronger evidence and better tools for evaluating safety questions related to licensed vaccines and vaccine components.
2. What is the main purpose of this FOA?
The purpose is to fund studies that clarify how vaccines interact with the human body, why adverse responses might occur in some individuals, and how researchers and public health agencies can more accurately detect, measure, and interpret potential vaccine safety signals.
3. How is this opportunity connected to national public health priorities?
The FOA is explicitly aligned with the U.S. National Vaccine Plan, meaning it is framed to advance national priorities related to vaccine confidence, monitoring, and vaccine safety science.
4. What grant mechanism does this opportunity use?
This opportunity uses the R01 mechanism, which is NIH's standard research project grant mechanism.
5. What types of research topics does the FOA emphasize?
The FOA highlights multiple research directions, including: (a) physiological and immunological responses to vaccines and vaccine components; (b) genetic variation and how it may influence immune or physiological responses relevant to vaccine safety; (c) identifying risk factors and biological markers related to evaluating whether licensed vaccines are associated with certain diseases or disorders; (d) statistical and methodological advances for analyzing vaccine safety data; and (e) use of modern genomic, molecular, and systems biology approaches to address vaccine safety questions.
6. Does the FOA focus on a specific vaccine or adverse event?
No. The scientific theme is broad and is not limited to any single vaccine or any specific adverse event. It is focused on improving the science, data, and analytic frameworks used to evaluate vaccine safety generally.
7. What does the FOA mean by studying physiological and immunological responses to vaccines?
This includes basic and translational research on immune activation, inflammation, reactogenicity, and other biological responses after vaccination. A key goal is to distinguish expected, normal immune responses from responses that could plausibly contribute to clinically meaningful adverse events.
8. How does genetics fit into vaccine safety research under this FOA?
The FOA encourages research on how genetic variation may influence immune or physiological responses in ways that could affect vaccine safety. This includes studying host genetics, gene-environment interactions, and differential responses across populations that may help explain why rare events might occur in a small subset of vaccine recipients.
9. What are "risk factors" and "biological markers" in the context of this FOA?
In this FOA, risk factors and biological markers are measurable indicators (such as biomarkers, immunologic profiles, or clinical predictors) that could help assess whether there is a relationship (or lack of a relationship) between certain diseases or disorders and licensed vaccines. The intent is to improve the ability to evaluate susceptibility, timing, and potential mechanisms when safety questions arise.
10. What kind of methods development is encouraged?
The FOA encourages methodological work, especially the creation or evaluation of statistical methods for analyzing vaccine safety data. This can include new signal-detection techniques, improved causal inference strategies, better observational study designs, and validation techniques intended to make findings robust and reproducible.
11. What types of data sources are referenced for vaccine safety analysis?
The FOA references real-world data streams such as passive reporting systems and healthcare databases. It also notes that these sources often have limitations like under-reporting, confounding, missing data, and reporting biases, and it encourages methods that address these challenges.
12. What does the FOA mean by "modern genomic and molecular technologies" and "systems biology" approaches?
The FOA calls for applying high-throughput and integrative approaches such as genomics, transcriptomics, proteomics, metabolomics, and systems-level analyses. The aim is to map pathways associated with adverse events or identify biological signatures of risk.
13. Is this funding opportunity considered a discretionary grant, and in what area?
Yes. The opportunity is categorized as a discretionary grant in the health area.
14. When was this FOA posted, and what are the relevant dates?
The FOA was posted and created on July 28, 2015. The original and current closing date listed is September 7, 2018. The opportunity was archived on October 8, 2018.
15. Are there cost sharing or matching requirements?
No. The announcement states there is no cost sharing or matching requirement.
16. What CFDA numbers are associated with this FOA?
The FOA is associated with multiple CFDA numbers: 93.283 (CDC Investigations and Technical Assistance), 93.317 (Emerging Infections Programs), 93.855 (Allergy and Infectious Diseases Research), and 93.856 (Microbiology and Infectious Diseases Research).
17. Which types of organizations are eligible to apply?
Eligibility is broad and includes many organization types across public, nonprofit, academic, and private sectors. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (with exceptions as described in the FOA); small businesses; and for-profit organizations other than small businesses.
18. Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The FOA explicitly includes institutions and entities such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.
19. Are tribal governments and U.S. territories eligible?
Yes. The FOA explicitly includes Native American tribal governments (federally recognized and other than federally recognized), as well as U.S. territories or possessions.
20. Are foreign (non-U.S.) organizations eligible to apply?
Yes. The FOA explicitly includes non-U.S. entities (foreign organizations) among eligible applicants.
21. Where can applicants find the official NIH announcement for PA-15-312?
The FOA points to the NIH grants page at: http://grants.nih.gov/grants/guide/pa-files/PA-15-312.html
22. Who is the listed contact for access or linking issues with the FOA page?
The contact provided is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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