Title: Development and Application of Vaccines
Keywords: Health economics
Health Policy (incl. advocacy)
Disease prevention & control
Communicable diseases (in general)
Country: Spain
Institution: Spain - Barcelona Institute for Global Health - University of Barcelona
Course coordinator: Denise Naniche
Date start: 2019-05-27
Date end: 2019-06-05
About duration and dates: 2019-05-24 to 2019-06-05, One day is added for pre-readings. A total of 1,7 weeks
Classification: advanced optional
Mode of delivery: Face to face
Course location: School of Medicine
University of Barcelona
C/ Casanova, 143
08036 Barcelona
SPAIN
ECTS credit points: 3 ECTS credits
SIT: Independent study hours: 49
Classroom hours: 26
Total: 75 h
Language: English
Description:

By the end of the course, students will be able to:

• Illustrate how vaccines work to provide individual and population immunity at an advanced level.

• Interpret the steps in the development of a safe, immunogenic and effective vaccine.

• Evaluate the challenges and obstacles of implementing immunization programs and strategies to improve their effectiveness.

• Critically discuss the factors that influence global vaccination policy, for existing vaccines as well as future vaccines.
Assessment Procedures:
The evaluation will be assessed individually. The final grade will be the result from:

1. A two-hour multiple-choice exam (70% of final grade).

2. Active participation in class (30%).

Final grades will be given 15 days after the exam.

Student participation in class will be assessed as follows:

• A grade of 5 or less corresponds to minimum, disruptive, or no participation;
• A grade of 8 corresponds to responding constructively to questions;
• A grade of 10 corresponds to asking perceptive questions and active constructive and educational interaction with colleagues and instructor.

Re-sit: Students failing to reach a minimum of 5 grade will be asked to take a new exam within the following 2 weeks after communication of the grade.
Content:

The course is divided into 13 two-hour sessions:

1. Introduction, history and current state of the art of vaccines
We start the course by travelling back a few centuries to the early stages of “vaccinology”. The session will then focus on the history of the vaccines that have shaped public health through the 20th century. The session will also allow students to become familiar with scientific contributions of pioneers in the field of immunization. The session will then move into discussion of vaccines currently available and gaps and challenges in meeting global health needs of the 21st century.

2. How do vaccines work? Harnessing the innate and adaptive immune responses
This session introduces 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.

3. 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 introduces the concept of correlates of immunity or 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.

4. Technical aspects of vaccine development: the preclinical phase 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 preclinical 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 preclinical vaccine development for existing and potential vaccines will be used for class discussion.

5. Steps in the development of a vaccine: from clinical trials to licensure
This session focus on the different phases of vaccine development prior to licensure. Students will learn the regulatory processes involved in licensing and commercializing 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.

6. Post-licensure evaluation of vaccine safety and effectiveness
This session delves 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 hour focus on post licensure evaluation of effectiveness of a vaccine.

7. Implementation and challenges of vaccine introduction
This session focus on the steps in introduction of a new vaccine. The session will cover the challenges in integrating a vaccine in national immunization programs. Factors such as the availability of site-specific data on disease burden as well as health system characteristics and policy issues and will be considered. The session introduces the various international bodies involved in promoting equity of access to vaccines as well as accelerating their uptake.

8. International policies and financing of vaccines
The first hour of the session introduces 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. The session also investigates 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 helps the student to understand the role, interests, and power games of the institutions instrumental in managing vaccines as a global public health good. Historically, the World Health Organisation (WHO) has been the key player. However, in the last 2 decades, other key stakeholders have emerged, such as the GAVI Alliance, the 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.

9. Vaccines in the community: acceptability, safety concerns and media responsibility
This session offers 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 considers the ways in which concerns over vaccine safety have emerged and have been disseminated through popular media, legislative hearings, and Internet-based activism. As a case study, we review the controversy over the alleged connection between autism and the measles-mumps-rubella (MMR) vaccine.

10. From development to implementation: the meningitis and HPV stories
This session introduces the principal challenges and barriers to the development and implementation of two vaccines crucial to global health: human papilloma virus and meningitis vaccines. These case studies will draw on information learned in the course.

11. Challenges in vaccine development: the case of HIV The case of HIV vaccine research and development is discussed to illustrate the scientific and political challenges currently shaping the development of vaccines for major global diseases. As well as providing a broad outline of the history and challenges of the global effort to develop a preventive HIV vaccine, the session provides an overview of the current state of affairs in the path towards an AIDS vaccine. We focus on the challenges related to the development of global public goods in health, including global coordination, the challenges of securing the engagement of the pharmaceutical industry both in developed and developing countries, the need to involve people from most affected communities, the regulatory hurdles, and the fundamental need to ensure that national authorities, funders, and policy makers ensure that AIDS vaccine development be a critical public health priority.

12. Future Challenges in Vaccine Development and Application
This session ties together the information learned during the course. We discuss the challenges facing the development of new vaccines in the 21st century.

13. Final examination (3 hours)
Methods:
Lectures will be combined with participative activities designed to assist students in assimilating information. Activities will include structured questions and exercises during the lectures to be resolved individually, in pairs or groups.

Students will have required reading material to prepare for the classes that may be included in the exam.
Prerequisites:
Students should have an advanced level of English. TOEFL test score 213 computer-based or 550 paper-based or 79-80 internet-based or IELTS band 6.0; or equivalent.
Attendance:
30 maximum students; 10 maximum tropEd students
Selection:
Students will be selected for this course based on a CV and letter of motivation.
Fees:
480 € plus university taxes
Scholarships:
There are no scholarships available for this course at the present time.
Major changes since initial accreditation:
We decided to change the main component of the student assessment from a paper submission to an examination. This was due to the fact that this course is usually scheduled at the end of the academic year in our master program, when most students are under pressure to finalize their MFP. Preparing a paper for submission was considered by students a time management conflict and asked the type of assessment to be changed.
Student evaluation:
This course has been consistently praised by students for being particularly well structured and step-wise developed. The presence of the coordinator in all sessions was also very well received.
Over the last five years, however, students expressed negative feedback about the teaching styles of some teachers. When that feedback was considered consistent, those teachers were replaced by new ones, without changing the objectives or the content. The last edition completed in May 2018 had a mean score of 4.7 out of 5 in the student feedback.
Lessons learned:
The regular presence of the coordinator in the classroom, contributing to connect the different course content, even if when he or she is not the teacher, clearly offers a distinctive learning benefit for students.
Student feedback is key to detect teachers who are not fit for purpose.
Courses close to the end of the academic year must avoid the inclusion of the submission of papers as an important part of the student assessment
tropEd accreditation:
Accredited in June 2014. This accreditation is valid until June 2019.

Re-accredited in October 2018. This accrditation is valid until October 2023.
Email Address: nuria.casamitjana@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: 2018-06-10 (W3C-DTF)
Date Last Modified: 2018-10-31 10:13:35 (W3C-DTF)

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