Everybody know vaccines, most of us we get vaccines on a regular basis, however the students will learn the difference between a vaccine and a the other medicinal products and this in all their aspects.
After this course the students will know:
• The evolution of vaccine science over time
• What are the different types of vaccines?
• How do vaccines work and how do they differ from other types of drugs?
• Epidemiological surveillance of communicable diseases and the success factors of vaccination programs
• Specific aspects of clinical studies on vaccines
• The role of regulators: vaccine benefits/risks and the consequences of vaccine approval in the EU and worldwide (role of the WHO)
• Current aspects of the vaccine industry, public acceptance of vaccination, and new technologies used for different vaccines
History of vaccines
Recap immunology: how do vaccines work?
Recap epidemiology applied to vaccine-preventable diseases and vaccination programs
What kind of vaccines do we have and how are they given
Specificities of vaccine clinical studies ; immunogenicity and vaccination schedules
How are vaccines registered and what is the difference with small molecules; vaccines manufacturing; post-authorization activities and health-economic aspects
Vaccines hot topics: vaccine hesitancy; life-course immunization; therapeutic vaccines: what do they stand for
A. What is vaccinology?
1. History of vaccine development, scientific principles as they developed over time
2. How do vaccines work? Basic immunology (humoral and cell-mediated, Th1-Th2) with examples applied to existing vaccines; adjuvants;
3. Types of vaccines & technologies (live-attenuated, inactivated: whole cell, polysaccharides, conjugated, acellular/subunit; recombinant, vector-based, DNA & mRNA, adjuvants and platforms)
B. Epidemiology, pathology, transmission of vaccine-preventable diseases, vaccination delivery, public health value of vaccination
4. Medical need, disease epidemiology, surveillance and vaccination registers, target populations, risk groups; immunization of pregnant women. Disease control, Elimination, Eradication
5. Vaccine-preventable diseases: description, transmission, herd immunity. Logistics and cold chain
6. Types of vaccination programs: campaigns vs routine; Expanded Program on Immunization (EPI);
7. Evaluation of vaccination coverage and program success; benefit-risk evaluation of vaccines
8. Basics of Health Economic models; private vs public markets; Value, RoI, Vaccine pricing; Tiered pricing, Health-Economic definitions, ICER, Discounting
C. Vaccine clinical studies
9. Immunogenicity and vaccine interferences; correlates of protection, surrogate markers (Elisa, OPA, neutralizing antibodies, endpoints
10. Clinical phases, “Proof of principle”, investigators and vaccine networks (KP, FinIP). Safety, adverse events, solicited vs unsolicited; Efficacy, effectiveness, persistence of vaccine protection
11. Vaccine schedules: priming and boosting; 2+1 vs 3+1; age for starting schedule in infants – depending upon diseases prevalence (pertussis vs polio vs Hib…)
12. Informed consent, ethical aspects of vaccine trials, vaccine studies in developing countries
D. Regulatory issues and vaccine recommendations, socio-economic aspects
13. WHO, EMA, FDA, other national authorities; Vaccine advisors, NITAGs, RITAGs; Regulatory approval, WHO Prequalification, Vaccine manufacturing
14. Vaccine Post-authorization activities: Pharmacovigilance, vaccine efficacy surveillance
E. Vaccine updates
15a. Future vaccines; Therapeutic vaccines
15b. Cancer vaccines
16. Antivaccine lobbies; Vaccine hesitancy; Influence of the Media; Appropriate training for Health Care Providers
17. Life-course immunization, vaccination of adults and older adults, need for boosters
18. Assessing the value of a vaccine (Group exercise)
During the course, students will choose from among the topics offered the one they will prepare with another student to present in class.
At the end of the course one role play: the students have to read a document from the EMA on the withdrawal of a new vaccine, the B/R is available, they have to prepare a discussion between the industry (the developer) and the authorities (Public Health)
The course is taught in an interactive lecture format.
In addition, students will choose from among the topics offered and prepare one with another student to present in class.
At the end of the course, there will be a role-play exercise: students must read the EMA summary report on a vaccine and prepare a discussion between the industry (the developer) and the authorities (public health).
Student assessment will be based on three elements: their presentation on the assigned topic during the course, a role-play involving defending a vaccine to the authorities, and two oral questions during the individual exam.
The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship.
Oral presentations with slides on the different topics
Internet websites from authorities.
Articles from different topics
Textbook “Vaccines” (Stanley Plotkin) : 7th Edition
| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Biomedical Sciences, Professional focus in Preclinical Research | Standard | 0 | 3 | |
| Master in Biomedical Sciences, Professional focus in Preclinical Research | Standard | 2 | 3 |