Research to Advance Vaccine Safety (R01 Clinical Trial Not Allowed) | PA 18 873

Opportunity Information: Apply for PA 18 873

Research to Advance Vaccine Safety (R01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity designed to support research that strengthens the scientific understanding of vaccine safety. The announcement invites investigator-initiated projects that deepen knowledge of how vaccines and their components interact with the body, with the larger goal of improving how vaccine safety is evaluated, monitored, and understood across populations. It is framed as an R01 grant mechanism and explicitly does not allow clinical trials, which means applicants should focus on non-trial human research, preclinical work, data-driven analyses, or methodological and mechanistic studies rather than prospective interventional studies assigning participants to vaccine-related interventions.

The scientific scope centers on multiple complementary areas that can inform vaccine safety from different angles. One major focus is characterizing physiological and immunological responses to vaccines and vaccine components, including work that compares or evaluates adjuvants and other formulation elements that may shape reactogenicity or rare adverse responses. Another emphasis is understanding how genetic variation influences immune and physiological responses that could affect safety outcomes, encouraging studies that link host genetics to patterns of response or susceptibility. The FOA also highlights the identification of risk factors that may contribute to adverse events or perceived associations, including infection history, underlying predispositions, or the presence of allergic and/or autoimmune disease. Closely related is the search for biological markers that could help assess whether and how certain diseases or disorders relate to licensed vaccines, with the intent of improving evidence quality and reducing uncertainty when safety signals arise.

Beyond mechanistic and risk-factor biology, the announcement strongly encourages work on advanced analytic and statistical approaches for vaccine safety assessment. This includes the development or evaluation of statistical methodologies suited to vaccine safety questions, particularly those using existing data resources such as passive safety reporting systems and large healthcare databases. Projects might address bias, confounding, signal detection, rare-event modeling, or methods that improve causal inference from observational sources. In addition, the FOA calls for the application of modern genomic and molecular technologies and systems biology approaches, supporting research that integrates high-dimensional data (for example, omics, molecular profiling, or network-based analyses) to better understand or predict safety-related responses.

This opportunity is positioned to align with the goals and objectives of the U.S. National Vaccine Plan, reflecting an interest in building durable scientific foundations for vaccine safety evaluation and public health decision-making. Administrative details indicate the opportunity is discretionary, uses the grant instrument, and falls under the health activity category, with CFDA numbers 93.084 and 93.855. The funding opportunity number is PA 18 873, and the record lists a creation date of July 24, 2018, with an original closing date shown as September 7, 2021.

Eligibility is broad and includes many typical applicant types such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations not federally recognized as governments; public housing authorities/Indian housing authorities; and a range of nonprofit organizations (both with and without 501(c)(3) status). For-profit organizations (other than small businesses) and small businesses are also eligible, along with additional categories listed as "Others." The FOA also explicitly notes additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, tribal governments other than federally recognized, and non-U.S. entities (foreign organizations). This wide eligibility reflects an intent to draw on diverse research settings, data resources, and scientific perspectives to advance the evidence base for vaccine safety.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Research to Advance Vaccine Safety (R01 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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