Opportunity Information: Apply for PA 12 037
Apply for PA 12 037
- The National Institutes of Health in the education 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): 93.361 Nursing Research 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Mar 26, 2015 and posted on Nov 28, 2011.
- Applicants must submit their applications by Jan 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments State governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities County governments Special district governments Small businesses.
- 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:
Research to Advance Vaccine Safety (R01) (Funding Opportunity Number PA 12-037) is a National Institutes of Health discretionary grant program designed to fund research that strengthens the scientific understanding of vaccine safety. The main goal is to support studies that can clarify how vaccines and vaccine components affect the body, why adverse events might occur in some individuals and not others, and how researchers and public health stakeholders can better evaluate vaccine safety signals using modern biological and analytical tools. The opportunity is framed around generating evidence that can improve how vaccine safety is studied, interpreted, and monitored, including work that draws on existing safety data resources.
The FOA highlights several specific research directions. One major area is the study of physiological and immunological responses to vaccines or their components, which can include investigating immune pathways, inflammatory responses, and other biologic mechanisms that might be relevant to adverse events. A second area focuses on genetics and individual variation, encouraging research on how genetic differences may shape immune or physiological responses after vaccination in ways that could influence safety outcomes. A third area emphasizes identifying risk factors and biological markers, meaning projects that aim to discover measurable indicators (such as biomarkers) or host characteristics that could help assess whether an observed disease or disorder might have a relationship to a licensed vaccine. A fourth area supports the development and testing of statistical methodologies for vaccine safety, including methods suited to analyzing data from established sources like passive reporting systems, where underreporting, reporting biases, and incomplete clinical detail can complicate interpretation. A fifth area encourages the use of genomic and molecular technologies to deepen understanding of vaccine safety, such as approaches that can detect biologic signatures, clarify mechanisms, or improve the resolution of safety assessments.
This is an R01 mechanism, meaning it is intended for substantial, hypothesis-driven or well-justified research projects that can produce meaningful advances in knowledge rather than small pilot efforts. The funding instrument type is a grant, and the activity categories align with health and education, with CFDA listings that include nursing research (93.361) as well as allergy, infectious diseases, and microbiology/infectious diseases research (93.855 and 93.856). The FOA states there is no cost sharing or matching requirement, which matters for budgeting because applicants are not expected to commit non-federal funds as a condition of award.
Eligibility is broad and includes many types of U.S. organizations and governments, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and other nonprofit structures), for-profit organizations other than small businesses, small businesses, independent school districts, and a range of local, county, state, special district, and tribal governments (including federally recognized tribal governments). The announcement also explicitly includes a variety of mission-focused institutions and community-based entities, such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Importantly, foreign institutions (non-U.S. entities) are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components as defined by the NIH Grants Policy Statement are allowed, which opens the door to international collaborations when they strengthen the science.
Key administrative details from the source record include an original posted date of November 28, 2011, with later record creation noted as March 26, 2015. The listed closing dates indicate the FOA ran through early 2016 (current closing date shown as January 7, 2016) and was archived on February 7, 2016, meaning it is no longer active in this form, though similar NIH vaccine safety opportunities may exist under newer announcements. The sponsoring agency is NIH, and the full archived announcement was provided through the NIH grants guide at the link in the source data. For access or technical issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster email.
Frequently Asked Questions (FAQs): Research to Advance Vaccine Safety (R01) - PA 12-037
What is the "Research to Advance Vaccine Safety (R01)" funding opportunity (PA 12-037)?
PA 12-037 is a National Institutes of Health (NIH) discretionary grant program that supports research intended to strengthen the scientific understanding of vaccine safety. The opportunity focuses on generating evidence that improves how vaccine safety is studied, interpreted, and monitored, including projects that make use of existing vaccine safety data resources.
What is the main goal of this FOA?
The main goal is to support studies that clarify how vaccines and vaccine components affect the body, why adverse events might occur in some individuals but not others, and how vaccine safety signals can be evaluated more effectively using modern biological and analytical tools.
What type of NIH award mechanism is this?
This opportunity uses the R01 mechanism. It is intended for substantial, well-justified (often hypothesis-driven) research projects that can produce meaningful advances in knowledge, rather than small pilot efforts.
What is the funding instrument type?
The funding instrument type is a grant.
What research topics and directions does the FOA emphasize?
The FOA highlights several research directions, including:
- Physiological and immunological responses to vaccines or vaccine components (for example, immune pathways and inflammatory responses that may be relevant to adverse events).
- Genetics and individual variation (how genetic differences may shape responses after vaccination and influence safety outcomes).
- Risk factors and biological markers (identifying host characteristics or biomarkers that may help assess whether an observed disease/disorder might be related to a licensed vaccine).
- Statistical methodologies for vaccine safety (including methods suitable for passive reporting system data where underreporting, reporting bias, and incomplete clinical detail can complicate interpretation).
- Use of genomic and molecular technologies to deepen vaccine safety understanding (detecting biologic signatures, clarifying mechanisms, or improving the resolution of safety assessments).
Does the FOA support research that uses existing vaccine safety data resources?
Yes. The opportunity is framed to encourage generating evidence that improves vaccine safety monitoring and interpretation, including work that draws on existing safety data resources.
Is this FOA focused on understanding adverse events following vaccination?
Yes. A central theme is understanding why adverse events might occur in some individuals and not others, including mechanistic and analytic approaches that improve evaluation of vaccine safety signals.
Does the FOA encourage biomarker research related to vaccine safety?
Yes. One of the explicitly listed directions is identifying risk factors and biological markers (biomarkers or host characteristics) that could help assess whether an observed condition might have a relationship to a licensed vaccine.
Does the FOA support methodological and statistical research for vaccine safety?
Yes. The FOA includes development and testing of statistical methodologies for vaccine safety, including methods designed for established data sources such as passive reporting systems where common limitations include underreporting, reporting biases, and incomplete clinical detail.
Does the FOA mention the use of modern genomic or molecular technologies?
Yes. The FOA encourages using genomic and molecular technologies to deepen understanding of vaccine safety, such as approaches to detect biologic signatures, clarify mechanisms, or improve safety assessment resolution.
Is there a cost sharing or matching requirement?
No. The FOA states there is no cost sharing or matching requirement, meaning applicants are not expected to commit non-federal funds as a condition of award.
Who is eligible to apply?
Eligibility is broad and includes many U.S. organizations and governments, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and other nonprofit structures), for-profit organizations other than small businesses, small businesses, independent school districts, and local/county/state/special district/tribal governments (including federally recognized tribal governments).
Are mission-focused and community-based entities eligible (such as HBCUs or faith-based organizations)?
Yes. The announcement explicitly includes historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
Are foreign (non-U.S.) institutions eligible to apply?
Yes. Foreign institutions (non-U.S. entities) are eligible to apply. The FOA also allows non-U.S. components of U.S. organizations and permits foreign components as defined by the NIH Grants Policy Statement.
Does the FOA allow international collaboration?
Yes. Because foreign institutions are eligible and foreign components are allowed (per NIH definitions), international collaboration is possible when it strengthens the science.
What agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What activity categories and CFDA listings are associated with this FOA?
The activity categories align with health and education. CFDA listings referenced in the source information include nursing research (93.361) and allergy, infectious diseases, and microbiology/infectious diseases research (93.855 and 93.856).
When was this FOA originally posted?
The source record lists an original posted date of November 28, 2011.
What does the record indicate about later updates or record creation?
The source record notes later record creation on March 26, 2015.
Is PA 12-037 still open for applications?
No. The closing dates shown indicate it ran through early 2016 (with a current closing date shown as January 7, 2016) and it was archived on February 7, 2016. That means this FOA is no longer active in this form.
If this FOA is archived, could similar NIH vaccine safety opportunities exist?
Yes. The information indicates this specific FOA is no longer active, but it also notes that similar NIH vaccine safety opportunities may exist under newer announcements.
Where was the full archived announcement provided?
The full archived announcement was provided through the NIH grants guide at the link referenced in the source data.
Who is listed as the contact for access or technical issues?
For access or technical issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster email.
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| 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 |
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