SC-27 - Intermediate/ Advanced Methods in Vaccine Safety and Effectiveness

The Intermediate/Advanced Methods in Vaccine Safety and Effectiveness course will cover high-level topics but has been attended in the past by students who are new to vaccines. Methodological lectures will include applied examples of studies implemented by experts in industry, the FDA, and academic medicine. Topics include test negative designs, self-controlled risk interval studies, target trial emulation, and pregnancy safety methods.

Overall Learning Objectives
To educate students on the application of intermediate and advanced pharmacoepidemiology methods to the real-world analysis of vaccine safety and effectiveness. The examples provided will focus on preventative vaccines, not therapeutic vaccines.

Lecture-Specific Learning Objectives
• Introduction to vaccine safety and effectiveness
• Provide an overview of the course
• Introduce vaccine safety and effectiveness from a global perspective and how standardized case definitions support this work.
Vaccine Safety
• Lecture 1: High-level overview of methods used in vaccine safety
o Explain how safety signals are evaluated in observational studies using real-world data and detail methods considerations for controlling measured and unmeasured confounding
o Provide an overview and compare methods for detecting safety signals using spontaneously reported cases and active surveillance systems
o Introduce the US’s passive and active safety surveillance systems, including VAERS, VSD, and Sentinel.

• Lecture 2: Applied use cases and discussion of pharmacoepidemiologic methods for evaluating vaccine safety in pregnancy
o Overview methodological challenges common to perinatal pharmacoepidemiology (ex.
o truncation bias, immortal time bias)
o o Detail analytic methods to account for methodological issues and conduct observational studies
o of vaccine safety during pregnancy
o o Provide Review examples from of recent pregnancy safety studies for RSV, COVID-19, and
o influenza vaccines led by academics in the US or Canada

Vaccine Effectiveness
• Lecture 1: TND & SCRI methods for vaccine effectiveness and how threats to validity were addressed in use cases (30 minutes)
o Describe methods used for vaccine effectiveness, their strengths, and limitations, including control of measured and unmeasured confounding (ex. healthcare seeking behavior)
o Describe methods (negative outcomes and linkages to outside survey data) used to assess the effect of unmeasured variables in claims-based studies of vaccine effectiveness
o Describe the causal approximation of effectiveness estimates from prospective cohort to test negative case control study
o Summarize the limitations, challenges, and key considerations of test negative case control and self-controlled risk interval studies

• Lecture 2: Target trial emulation for estimating vaccine effectiveness
o Provide an overview of target trial emulation methods, including assessment of fit-for-purpose real world data
o Discuss target trial emulation in the context of vaccine effectiveness and safety; map key constructs to vaccine clinical trials
o Review examples of how target trial emulation has been used to evaluate the effectiveness and safety of COVID-19 vaccines

2025 Course Schedule (3.5 hours)
1. 1. Introduction – Primary: Jennifer E. Gerber, PhD, MSc (20 min.)
a. Provide an introduction to pharmacoepidemiology for vaccine effectiveness and safety, including the need for standardized case definitions

2. Vaccine Safety (70 min. in total)
a. Lecture 1: High-level overview of methods used in vaccine safety and applied use cases – Henok Tadesse Ayele, PhD, MPH, MSc
i. Including methods used for passive and active surveillance and self-controlled risk intervals for evaluating vaccine safety
b. Lecture 2: Applied use cases and discussion of pharmacoepidemiology for pregnancy safety (30 min.) – Annette Regan, PhD, MPH
c. Q&A (10 min.)

3. Coffee Break (15 min.)

4. Vaccine Effectiveness (60 min. in total, each lecturer has 30 min., including pulling up their slides)
a. Lecture 1: Test negative designs, self-controlled risk intervals, and other methods used to evaluate vaccine effectiveness (30 minutes) – Caroline Korves, ScD
i. Includes how threats to validity were addressed in use cases
b. Lecture 2: Target trial emulation for estimating vaccine effectiveness (30 min.) – Katie Mues, PhD
c. Q&A (10 min.)

5. Panel Discussion with Q&A (20 min.) – Moderated by Jennifer E. Gerber, PhD, MSc, O’Mareen Spence, PhD, and Robert Chen, MD

6. Course Evaluation Completion (5 min.)
a. Please bring an electronic device so that you can complete ISPE’s brief questionnaire

Resources for Students
• Vaccination Programmes: Epidemiology, Monitoring, Evaluation. 1st Ed. (routledge.com; open access)