Title: Development and Application of Vaccines in Global Health
Keywords: Health Policy
Drugs and vaccines
Disease prevention, control and elimination
Communicable diseases
Country: Spain
Institution: Spain - Barcelona Institute for Global Health - University of Barcelona
Course coordinator: Denise Naniche
Date start: 2025-06-10
Date end: 2025-06-19
About duration and dates: Duration: 8 days in two weeks (June 5-7 and 10-14). Application deadline: May 1st 2024. Readings (including essential and recommended) will be distributed prior to course commencement.
Classification: advanced optional
Mode of delivery: Face to face
Course location: School of Medicine
University of Barcelona
C/ Casanova, 143
08036 Barcelona
ECTS credit points: 3 ECTS credits
SIT: Classroom hours: 24
Independent study/work hours: 49
Evaluation hours: 2 hours
TOTAL: 75 hours
Language: English
Description: At the end of the course, participants will be able to:

1. Explain how vaccines work to provide individual and population immunity at an advanced level.
2. Describe the steps in the development of a safe, immunogenic and effective vaccine.
3. Evaluate challenges and obstacles to implementing immunisation programs and strategies to improve their effectiveness.
4. Appraise the factors that influence global vaccination policy, for existing vaccines as well as future vaccines
Assessment Procedures: Students will be evaluated individually through a two-hour exam including multiple-choice and short answer questions (100% of final grade). Rubric will be uploaded in the Virtual Campus.
The exam will take place on June 14th 2024 from 9:00-11:00.
Content: DAY 1
S1: Introduction, history and current state of the art
The first class will introduce the concept of vaccination as one of the most successful worldwide interventions in reducing disease burden and mortality. The first part of the session will focus on basic vaccine concepts and on the history of the vaccines which have shaped public health. The session will then move into global achievements of vaccines from disease control to eradication.
S2: How do vaccines work? Harnessing the innate and adaptive immune responses
This session will introduce concepts of innate and adaptive immunity necessary for understanding how the immune system mounts an immune response and provides protection against pathogens. Since many vaccines are delivered at a very early age, we will also cover the development of fetal and infant immune systems and their response to vaccines. Students will be introduced to concepts of passive and active immunity as well as key differences in the immune response according to types of antigens present in pathogens and/or vaccines.

S1: Long term immune protection and correlates of immunity
The concept of immunological memory both at the individual level and at the population level will be covered. Students will study the types of immunogens and immune responses which give rise to long term protective immunity. In class discussion will focus on the successes and challenges in inducing long term immunity through vaccination. The second hour of the class will introduce the concept of correlates of immunity and how vaccinologists define and measure protective immunity. Examples of traditional biological markers used as correlates of immunity as well as newer approaches will be used for class discussion.
S2: Technical aspects of vaccine development: the pre-clinical phase (emphasis and examples of malaria)
This session will focus on the process of antigen discovery and selection of vaccine candidates. Students will learn the advantages and disadvantages of different immunogen delivery strategies including vectors, DNA, adjuvants and proteins. The extensive process of pre-clinical vaccine development will be detailed including the steps involved in in vitro and animal model testing of vaccine candidates prior to human clinical trials. Examples of pr-eclinical vaccine development for existing and potential vaccines will be used for class discussion.

S1: Steps in the development of a vaccine: from clinical trials to licensure
This session will focus on the different phases of clinical development of a vaccine prior to licensure. Students will learn the steps of the regulatory processes involved in licensing a vaccine as well as mechanisms for ensuring quality of the final product. Examples of the steps involved in clinical development, licensing, certification and production of existing vaccines will be used for in class discussion.
S2: Post-licensure evaluation of vaccine safety and effectiveness
This session will delve into the issues of how adverse vaccine events are monitored and their impact on vaccine policy. The discussion will cover aspects of post licensure surveillance for low frequency adverse events as well as for vaccine safety in vulnerable populations.
The second part of the session will focus on post licensure evaluation of effectiveness of a vaccine. We will cover methodology and challenges in assessment of vaccine effectiveness.

S1: International policies and financing of vaccines
The first hour of the session will introduce the concept of Global Health Public Goods (GHPG) which identifies a ‘good’ or service as a global benefit which would not be produced or disseminated if left to market forces. This session will investigate the challenges related to the concept that no-one should be excluded from accessing the good. Vaccines are considered the paradigm of GHPG.
The second hour will help the students to understand the role, interests, and power games of the organizations instrumental in managing vaccines as a global public health good. Historically, the World Health Organization has been the key player. However, in the last 2 decades, other key stakeholders have emerged, such as Gavi the Vaccine Alliance, Product Development Partnerships (PDPs) and the Bill & Melinda Gates Foundation. This
session will give an overview of the complex scenario generated by the proliferation of new actors with overlapping vaccine agendas.
S2: Vaccines in the community: acceptability, safety concerns and media responsibility
This session will offer the student a logical framework to understand the controversial topics surrounding vaccine risk communication. Uncertainty about vaccine risks and benefits has spurred the need for vaccine risk communication. Often poorly understood adverse events are at the heart of a controversy where existing communication appears inadequate.
The second hour of the session will consider the ways in which concerns over vaccine safety have emerged and have been disseminated through popular media, legislative hearings, and Internet-based activism.

S1: Implementation and challenges of vaccine introduction
This session will focus on the steps in the introduction of a new vaccine. The session will cover the challenges in integrating a vaccine in the national immunisation programmes. Factors such as the availability of site-specific data on disease burden, as well as health system characteristics, and policy issues will be considered. The session will introduce the various international bodies involved in promoting equity of access to vaccines, as well as accelerating their uptake.
S2: Logistics of introducing vaccines and maintaining immunization programs
This session will introduce the principal challenges and barriers of the introduction of new vaccines and the maintenance of immunization programmes in times of crisis. Issues such as cold chain, vaccine availability and stability, data, scaling up and equitable access will be considered. The session will introduce the steps and processes involved in ensuring safety and continuity of immunization, be it in routine or emergency situations.

S1: Challenges in new vaccine development: case studies
The session will use a practical in-class exercise to apply the knowledge gained thus far in the course. We will address the challenges including the scientific, clinical, regulatory, safety and community issues relevant to developing a new vaccine.
S2: Review and Wrap up
This session will tie together and review the information learned during the course with questions from students. We will also discuss the challenges facing the development of new vaccines in the 21st century.

Self-study day to prepare for the exam

Final examination (2h)
Methods: The course is based on active participatory learning methods such as: Participation in class discussions is encouraged by facilitators.
Activities will include structured questions and exercises during the lectures to be resolved individually, in pairs or groups.
Students will be required to read materials to prepare for the classes that may be included in the exam.
Prerequisites: Previous knowledge of immunology will be helpful but not required, and for those with none, additional learning tools will be provided

tropEd candidates must accredit an English language level TOEFL test 550 or 213 computer-based or 79/80 internet-based or IELTS band 6.0 or equivalent.
Attendance: A minimum of 10 students is required for the course to take place. Maximum 45 students.

No limitation for number of tropEd students, but in house students have priority.
Selection: For tropEd students: First come, first served.
Fees: Academic year 2023-24 fee: 525€ + University taxes (90€ approx.)
Scholarships: Not available.
Major changes since initial accreditation: Any changes in course coordinator, objectives, content, learning methods, assessment procedures need to be described with a short explanation about the reason for this change.

The course has evolved and adapted to new knowledge, evidence and scientific developments along time. Feedback from annual students’ evaluation of the course has been considered to improve content and methodology.
Lessons learned: Practical approach and applicability opportunities should be considered when developing activities in the course.
Since this is a course for the postgraduate students in global health, be aware that not all students have a medical background and that we need an interdisciplinary approach.
tropEd accreditation:
Accredited in June 2014. Re-accredited in October 2018 and in September 2023. This accreditation is valid until September 2028.
Email Address: denise.naniche@isglobal.org
Date Of Record Creation: 2014-06-23 05:58:09 (W3C-DTF)
Date Of Record Release: 2014-06-23 11:14:03 (W3C-DTF)
Date Record Checked: 2019-08-14 (W3C-DTF)
Date Last Modified: 2024-06-11 10:29:22 (W3C-DTF)