Activities DGfI YI

Title: Pre-clinical and clinical development of novel anti-viral vaccines

Lecturers:
Dr. Stefanie Krumm, Infectious Disease Vaccines, BioNTech
Univ.-Prof. Dr. med. Leif Erik Sander, Department of Infectious Diseases, Respiratory and Critical Care Medicine, Charité-Universitätsmedizin Berlin, Berlin Institute of Health, Berlin

Stefanie Krumm: Development of Prophylactic Infectious Disease mRNA-based Vaccines: The COVID-19 pandemic highlighted how crucial the rapid provision of a vaccine is to reduce worldwide propagation and to protect against severe outcomes associated with infection. The need for fast, flexible and scalable vaccine development are key challenges in the control and prevention of newly emerging and re-emerging infectious disease pathogens. To address these challenges, BioNTech SE is developing innovative mRNA-platform vaccines against various infectious disease pathogens which would allow rapid manufacturing for population-wide vaccination. This seminar lecture focuses on the preclinical development of suitable vaccine candidates and the usage of different in vitro transcribed mRNA vaccine platforms for prophylactic vaccines. Preclinical development starts with target analysis and rational vaccination strategy and antigen design. Antigen candidates are then subjected to various in vitro and in vivo testing including antigen expression, formulation evaluation to protect mRNA against degradation and the induction of a directed immunogenic reaction characterized by antigen-specific B-cell and T-cell responses. The complex analysis guides further antigen improvements towards identification of a vaccine candidate suitable for clinical development.

Leif Sander: The clinical development of vaccines traditionally follows a phased approach: from preclinical r&d and testing in animal models, followed by clinical trials in three phases—Phase 1 (safety and dosage in a small group), Phase 2 (expanded safety and immune response data), and Phase 3 (large-scale efficacy trials). Upon regulatory approval, vaccines undergo post-market surveillance for long-term safety. This process typically takes 10–15 years. During the COVID-19 pandemic, vaccine development was significantly accelerated to under a year. This was enabled by unprecedented global collaboration, parallel trial phases, and real-time “rolling” regulatory reviews. Scientists could leveraged decades of research on coronaviruses, and vaccines including mRNA and viral vector platforms. Lastly, large-scale manufacturing began prior to final approvals to ensure immediate vaccine distribution. Additionally, massive funding and corporate investments removed financial barriers that usually prolong the vaccine development process, while global trial participation provided fast, robust data. Here I will go through the different steps of clinical vaccine development and also discuss barriers and bottlenecks for novel technologies and bott as well as promising new developments in this area of life-saving medicines.

About the speaker Stefanie Krumm: Throughout her scientific career, Dr. Stefanie Krumm’s research focused on therapeutics and prophylactic vaccine development against various virial pathogens. After obtaining her technical Biology degree at the University of Stuttgart, she focused her doctoral studies on the characterization of host and pathogen directed small-molecule inhibitors against RNA viruses in vitro and in vivo. During her postdoctoral position at King’s College in London, she investigated HIV glycan targeting broadly neutralizing antibody development and viral escape mechanisms as well as (non-) neutralizing antibody responses to protein-based vaccines against emerging hemorrhagic fever viruses. Dr. Krumm joined the Infectious Disease Vaccine unit at BioNTech in 2018 as a scientist working on the preclinical development of prophylactic RNA based vaccines against various infectious diseases, and she now heads the platform development subunit.

About the speaker Leif Sander: Leif Erik Sander is a physician scientist, specialized in internal medicine, pulmonary medicine and clinical infectious diseases. From 2008 to 2011, he trained as a postdoctoral fellow in immunology at the Icahn School of Medicine at Mount Sinai, New York. In 2012, he established a research group at Charité in Berlin and by 2016, he became a Professor for Immunology and Vaccine Research at Charité. Since 2022, he heads the Department of Infectious Diseases and Critical Care Medicine at Charité and leads a research group on ‘Personalized Medicine in Infectious Diseases’ at the Berlin Institute of Health.
His research focuses on antimicrobial immune responses, vaccine development, and novel anti-infective strategies. His team investigates safety, immunogenicity and effectiveness of vaccine, including a recent multicenter trial assessing the effectiveness of MVA vaccination against MPOX. He served as a member of the expert advisory panel to the German government on COVID-19. He hold several patents for novel vaccine candidates and has a keen interest in translation and innovation in the field of infectious diseases.

Together with the YI podcast host Nóra Balzer, YI proudly presents the start of the second podcast season! New content on academic research topics and beyond will be published every month.

In this special holiday edition, the Young Immunologist Board of the German Association of Immunology has shared their top advice to help YOU level up your scientific career in 2025. Whether you’re just starting out in your PhD or gearing up for your next big career move, this episode is packed with tips you don’t want to missent of the biotech field. The gender gap in science startups and the mindset change in science towards entrepreneurship are debated as well.

We also encourage you to revisit some of our current episodes. Whether you’re catching up on missed episodes or re-listening to your favorites, there’s plenty of content to keep you engaged and informed.

Curious? Follow the link and let us know your thoughts via our socials or e-mail to youngimmunologists@dgfi.org.

Read about the podcast in EJI (https://onlinelibrary.wiley.com/doi/10.1002/eji.202350595).

Programming skills are becoming more important. Our YI* Coding Club conducts in-person meetups with advanced researchers, an online seminar including a hands-on tutorial by one of our YI members and an online summer programming session on R introduction focused on data visualization. Find us on a slack channel in the YI community slack workspace.

In this series of lectures, the DGfI Commission on Gender Equality and Career Development provides a forum for excellent female immunologists. They will share their exciting research, but also talk about their experiences in forming a career as women in STEM (=MINT).

Programme
29.01.2025 | 4-6pm | Prof. Dr. Susana Minguet
21.05.2025 | 4-6pm | Prof. Dr. Eva Tolosa