Epidemiological Studies of Vaccination and Health Outcomes Across the Lifespan

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Topic Description

Post Date: June 3, 2026

Expiration Date: June 3, 2028

Vaccines have long been effective tools for preventing infectious disease, yet comprehensive evaluation of their relationships with both positive and negative long-term health outcomes across the lifespan remains limited. Most prior studies on adverse events have focused on short-term outcomes. Further refining our understanding of long-term health outcomes requires newer data sources, comprehensive health outcome information, more robust study designs, and improved analytic approaches. 

Moreover, as concluded by the 2013 Institute of Medicine report The Childhood Immunization Schedule and Safety, and by the White Paper from CDC’s Vaccine Safety Datalink (Glanz et al., Vaccine, 2016), there is a need to evaluate various aspects of the childhood vaccination schedule. Prior analyses have also highlighted methodological and data-related challenges, including limited ability to capacity to compare schedule variations, consideration of common and novel vaccine product components, insufficient integration of clinical outcomes with biological and environmental data, and insufficient consideration of population heterogeneity – factors that could support personalized risk-benefit decisions and the development of  precision vaccination strategies for specific vulnerable subpopulations. 

Advances in real-world data (RWD), large-scale longitudinal cohorts, biospecimen linkages, biomarker identification, and data integration platforms now provide new opportunities to address these gaps, through comprehensive, population-level analyses of vaccination exposures and long-term health outcomes. When combined with biomarker and mechanistic data, these approaches can support causal inference and identification of effect modifiers across diverse populations, although careful attention to confounding biases and multiple comparisons is essential. To ensure rigor and interpretability, studies should prioritize standardized measurements, bias mitigation, appropriate statistical methods, large sample sizes, and replication across independent populations.

NIH seeks to encourage investigator-initiated research in the following areas:

  • Large-scale epidemiological studies
  • Long-term health outcomes
  • Vaccine exposures 
  • Multi-omics and subpopulations
  • Transparency and reproducibility
This topic is being issued as part of the Make America Healthy Again initiative, which is expanding NIH and agency research into specific areas.

It aligns with:

  • Vaccine Injury : HHS, in collaboration with NIH, will investigate vaccine injuries with improved data collection and analysis, including through a new vaccine injury research program at the NIH Clinical Center that may expand to centers around the country.

Scientific Contact:
NIAID VIHTAL HT
[email protected]

Participating ICOs

National Institute of Allergy and Infectious Diseases (NIAID)

NIAID encourages applications addressing vaccine safety, efficacy, and potential harm within its mission areas. Studies should combine rigorous epidemiologic designs with mechanistic approaches to evaluate long-term health outcomes, specific vaccine exposures, and susceptible populations. Priority focus areas include:

  • Leveraging large-scale longitudinal cohorts and real-world data to assess long-term health outcomes, including rare or delayed vaccine-associated events.
  • Evaluating vaccine schedules, components, platforms, and timing, including cumulative and interacting exposures.
  • Identifying biomarkers, immune signatures, and mechanisms underlying heterogeneous responses and long-term outcomes.
  • Integrating multi-omics, systems biology, and clinical data to understand how vaccines affect the immune system over time. 

This topic aims to strengthen the understanding of vaccine benefits and potential adverse outcomes to support data-driven, evidence-based vaccination strategies.

National Institute of Environmental Health Sciences (NIEHS)

The National Institute of Environmental Health Sciences (NIEHS) is interested only in applications that focus on the interaction between vaccine exposures and environmental exposures with relevance to human health outcomes. Environmental exposures of interest include, but are not limited to: air pollutants, pesticides, industrial by-products, trace elements (e.g., metals and metalloids), nanomaterials and microplastics, endocrine disrupting chemicals, persistent organic pollutants, emerging compounds and contaminants of concern, environmental radiation, and environmental exposures resulting from extreme weather events or disasters.

The NIEHS Worker Training Program and the Superfund Research Program are not participating in this topic.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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