Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Karin Bok, MS, PhD
Deputy Director
Office of Vaccines Research & Review
Center for Drug Evaluation and Research (CDER) |
US Food and Drug Administration (FDA)
Dr. Karin Bok is the Deputy Office Director of the Office of Vaccines Research and Review, Food and Drug Administration. She provides Office-level oversight and support of regulatory reviews and actions on vaccines and related biologics, including allergenics, live biotherapeutic products, and bacteriophages. Dr. Bok’s expertise covers a wide range of preclinical and clinical development of preparedness and response medical countermeasures, including preventive and therapeutic products against Ebola, Zika, Nipah, Influenza, and Coronavirus. She also had a key role in the development of broadly neutralizing monoclonal antibodies for HIV, as well as universal influenza and RSV vaccines. Karin has extensive experience collaborating with government colleagues and external stakeholders in areas of research and policy, including vaccine safety and maternal immunization. She also held a leading role in H-CORE (HHS Coordination Operations and Response Element, former Operation Warp Speed) contributing to accelerating the development and testing of vaccines against SARS-CoV-2 in the US.
Abstract
Karin Bok, deputy office director of FDA’s Office of Vaccines Research and Review, presents on “The Power and Promise of mRNA Vaccines” at the 2024 CITC, detailing the decades of scientific breakthroughs that enabled this technology. She explains how innovations like capping, tailing, codon optimization, and crucially, lipid nanoparticles facilitate effective delivery of mRNA into cells. The presentation highlights the synthetic, cell-free manufacturing process of mRNA vaccines, which allows for rapid production and scaling not possible with traditional methods. These vaccines deliver antigens intracellularly, stimulating a broad immune response including not only antibodies and CD4 cells but also CD8 cells. Bok emphasizes the high efficacy of SARS-CoV-2 and RSV mRNA vaccines, which demonstrated over 90% effectiveness in trials and in real-world use. Safety is a paramount consideration, with risks like myocarditis carefully monitored and contextualized against the often higher risks of natural infection. While antibody levels may decline over time, memory B and T cells provide durable immunity. The platform’s inherent adaptability and speed position it as an ideal system for rapid response to emergencies and for developing new vaccines, with many more mRNA-based vaccines currently in the pipeline.