CEC01-01 Introduction to the course and working group assignment

This Education Course is part of the CE identified by the Education Subcommittee at EUROTOX. Vaccines are an important topic in light of new infections, just think of the Corona virus 2019-n-CoV pandemic that has upset our lives and from which we have not yet emerged or the SARS between 2002 and 2003, or that of MERS between 2012 and 2019. This course will focus on vaccines from design, to efficacy and regulatory requirements. The course includes three lectures followed by an intense group work in the afternoon in order to stimulate the participation of learners as much as possible. The course participants will be divided into groups of maximum six which, led by the teachers, will deepen aspects such as the design of a new vaccine, the factors that influence the response to a vaccine, side effects and ethical issues related to the use of animals in vaccine testing. Three different vaccines accepted by EMA, namely Comirnaty, a COVID-19 mRNA vaccine (nucleoside-modified), Jcovden, an adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S) vaccine, and Nuvaxovid, a recombinant, adjuvanted COVID-19 Vaccine, will be used as examples. This will allow to familiarize with the regulatory requests for authorization purposes, including the preclinical and clinical data that must be provided, of three different types of vaccines (e.g. traditional, RNA, adenovirus).