Course Syllabus
Course Overview:
This 8 session, two-credit course focuses on vaccines and immunization, one of the most important public health interventions of the 20 & 21 centuries. The goal of this course is to learn about vaccines through the lens of COVID-19 disease and vaccines. We will discuss development, production, distribution, safety and efficacy testing, program implementation and regulation. Enrollees will be divided into groups of 4-6 students. Each group will be assigned a specific COVID-19 vaccine platform in order to facilitate discussion of the steps of moving from concept to testing, through regulatory approval and distribution of the final product. There will be time both during and between lectures for students to discuss relevant issues with the faculty. Relevant reading materials will be provided. Discussion board questions and/or specific assignments relevant to presented material will be used to expand our understanding of this subject matter.
Goals & Objectives:
At the conclusion of the course, students will be able to:
- Describe and differentiate the different types of COVID-19 vaccines, how they work and the relationship between vaccine characteristics, age for administration, and need for booster doses.
- Understand the role of COVID-19 vaccines in controlling COVID-19 related illnesses on an individual and community level.
- Appreciate the steps needed for a COVID-19 vaccine to become licensed, added to the routine immunization schedule, and covered by public and/or private payers.
- Become familiar with the tools used to measure vaccine coverage in general and to measure adverse reactions to specific vaccines.
- Be aware of the systems in place to monitor the safety of licensed vaccines in general, and have an understanding of current COVID-19 vaccine safety issues.
- Be aware of factors contributing to underutilization of vaccines, and vaccine hesitancy.
- Understand the process of vaccine development and delivery issues in general, and specifically as they relate to COVID-19 vaccines.
- Be knowledgeable about new developments in vaccinology.
Suggested and Supplemental Readings:
Plotkin's Vaccines, 7th Edition, 2017. Editors: Stanley A. Plotkin & Walter Orenstein & Paul A. Offit & Kathryn M. Edwards
Understanding Modern Vaccines: Perspectives in Vaccinology, London, Elsevier, 2011. Editors: Garçon N, Stern PL, Cunningham AL, Stanberry LR. https://www.sciencedirect.com/journal/perspectives-in-vaccinology
See required readings in Modules on Courseworks.
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Date |
Topics |
Lecturer(s) |
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Tuesday, January 12, 2021 |
History of Vaccines Learning Objectives: A history of vaccination from ancient to modern times Vaccine immunology 101 Learning Objectives: Primary & secondary immune Response Active vs. passive protection Age dependent development of immunologic protection Vaccine Makeup and Development Issues Learning Objectives: Live attenuated, killed, protein subunit, RNA or DNA? The role of adjuvants? Technical issues that can impact the speed of development |
Philip LaRussa, MD and Lawrence Stanberry, MD, PhD |
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Tuesday, January 19, 2021 |
Goals of an Immunization Program Learning Objectives: Establishing Medical Need Role of epidemiological data in developing and monitoring immunization strategy Active & Passive surveillance programs (e.g. Influenza, Varicella, Polio) Eradication vs. limitation Universal vs. targeted immunization Develop a Target Product Profile (TTP) Learning Objectives: Indication for use Target population Safety/Reactogenicity Efficacy Dose regimen Durability of protection Route of Administration Coverage Product Stability and Storage Co-administration with other vaccines Presentation Registration and Prequalification |
Philip LaRussa, MD and Lawrence Stanberry, MD, PhD |
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Tuesday, January 26, 2021 |
How do you measure efficacy? Learning Objectives: Disease prevention Surrogate markers What does it take to develop, obtain regulatory approval for and manufacture a vaccine? Phase I, II, III & IV clinical studies What type of study design is preferred: cohort, case control, environmental? How do you measure safety? Learning Objectives: Anticipating safety issues, e.g., antibody enhanced disease Preliminary safety testing Age dependent immune responses Testing in susceptible individuals vs. those with prior immunity Testing in special populations, e.g., immunodeficient subjects, children, elderly How safe is safe enough? Public perception vs. scientifically collected data Role of the popular media Vaccine hesitancy, and refusal |
Philip LaRussa, MD and Lawrence Stanberry, MD, PhD |
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Tuesday, February 2, 2021 |
Overview of Coronavirus virology & clinical disease Learning Objectives: Brief overview of current epidemiology, and clinical presentations Coronavirus Vaccine Makeup & Development Issues Learning Objectives: Brief overview of COVID Vaccine platforms in development What type of partnerships will be necessary between academic, government, industry, and NGO’s to bring CoVID-19 vaccines to the public? |
Philip LaRussa, MD and Lawrence Stanberry, MD, PhD |
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Tuesday, February 9, 2021 |
Current and past Immunization Programs Learning Objectives: Programs in resource-rich vs. resource-poor countries Examples of past & current immunization campaigns: Smallpox, Polio, Influenza, Ebola Immunizations & the legal system Learning Objectives: Individual rights vs. the greater good Role of the legal system in managing this balance Mandated vs. recommended immunizations School entry & job entry requirements Current legal issues *with discussion |
Philip LaRussa, MD |
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Tuesday, February 16, 2021 |
Zoom breakout session for teams to meet and work on their team presentations. Drs. LaRussa and Stanberry will visit each breakout room and be available to answer questions. |
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Tuesday March 2, & 9, 2021 |
Student presentations; Final assignment is to develop and present (45 minutes + 15 minute Q&A, each group) a final plan that will include the following elements: 1. Describe and discuss the pro and cons of your vaccine construct 2. Describe and discuss the pro and cons of route of administration including vaccine delivery devices, if applicable. 3. Describe your proposed preclinical toxicology, immunology and efficacy studies 4. Present your Target Product Profile 5. Present an abbreviated Phase 2B trial design 6. Present an abbreviated Phase 3 trail design including the following elements: a. Population to be enrolled with inclusion and exclusion criteria b. Estimated duration of the trial c. Immunization schedule d. Primary outcome measure and how the outcome will be determined/measured e. Secondary outcome measures (up to 3) and how they will be determined/measured f. Immunology studies and when samples will be collected g. Describe how you will determine sample sizes for primary efficacy and safety outcomes 7. Present an abbreviated post-marketing phase 4 study design, proposing outcomes to be explored. 8. Assuming that your Phase 3 clinical trial shows safety and efficacy, briefly describe who you will seek approval from (FDA and/or WHO), and for what indication(s)? 9. Assume you are members of the ACIP or WHO committee that will determine who should first receive the vaccine when becomes available. Please describe and defend your top five populations (who, and in what situation). |
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