Assessing the safety of COVID-19 vaccines using advanced statistical methods

A risk-varying and perturbed self-controlled case series design for assessing the safety of COVID-19 vaccines in a large health care system

NIH-funded research Kaiser Foundation Research Institute · NIH-11076736

This study is looking into how safe COVID-19 vaccines are, especially focusing on concerns about serious side effects like blood clots, to help people make better choices about getting vaccinated.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionKaiser Foundation Research Institute NIH-funded
Lab location1 site (Oakland, UNITED STATES)
Project IDNIH-11076736 on NIH RePORTER

What this research studies

This research investigates the safety of COVID-19 vaccines by developing new statistical models that can accurately assess the risk of severe adverse events (SAEs) associated with these vaccines. It aims to address concerns about vaccine safety, particularly regarding blood clots linked to the Janssen vaccine and the two-dose mRNA vaccines. By analyzing existing healthcare data and improving methodologies for evaluating vaccine safety, the research seeks to provide clearer insights into the risks involved in vaccination. Patients may benefit from enhanced safety monitoring and more informed decisions regarding COVID-19 vaccination.

Who could benefit from this research

Good fit: Ideal candidates for this research include individuals who have received or are considering receiving COVID-19 vaccines and have concerns about potential adverse effects.

Not a fit: Patients who have not received any COVID-19 vaccines or those who are not considering vaccination may not benefit from this research.

Why it matters

Potential benefit: If successful, this research could lead to improved safety assessments of COVID-19 vaccines, helping to alleviate vaccine hesitancy and promote public health.

How similar studies have performed: Other research has successfully utilized advanced statistical methodologies to assess vaccine safety, indicating that this approach has potential for meaningful insights.

Where this research is happening

Oakland, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.