Vaccines

Abstract

The course on Vaccines covers different steps in the development of vaccines from the selection of target infection through to post-approval surveillance. Specific aspects in production of viral and bacterial antigens and the final vaccine, in clinical development of the vaccine, the regulatory requirements and pharmacovigilance will be discussed. Aspects of therapeutic vaccines will be discussed

Objective

Students acquire the ability to anticipate problems, analyse complex situations, and offer a strategy for the development of vaccines. Students understand the complexity of vaccine development and production. Students can define interaction with different partners involved in the development/production af a vaccine and with the competent authority during the approval procedure. Students understand possibility of vaccines against medical diseases.

Content

Production of antigen and final vaccine: - Bacterial and viral antigens: Isolation, purification, research&development production - Modification of antigen: Toxin to toxoid, polysaccharide-protein complex (conjugation - Formulation and stability - Manufacturing of final vaccine - Requirements regarding manufacturing suites, gowning, hygiene, etc. Regulatory specifics: - Differences between pharmaceuticals and biologicals - The manufacturing process in biologicals - Batch release - Variations /Changes - Stability testing Vaccine Safety Basics & Vaccine Pharmacovigilance: - Vaccine Safety Basics(What is a vaccine & how does it work? What side effects are to be expected following vaccination? Historical vaccination incidents vs challenge of vaccine safety today) - Vaccine Pharmacovigilance (Regulatory framework, Adverse Event (AE)/ Adverse Event Following Immunisation (AEFI), Clinical trials, spontaneous and literature reports, Pharmacovigilance Principles) - Applying Pharmacovigilance in Day-to-Day practice (Case study: Interactions between PV and Quality) Therapeutic Vaccines - Prophylactic vs. Therapeutic Vaccines - Immunological Background and Vaccine Design. - Virus Like Particles: Nature's Nanoparticles - Case studies; Preclinical and Clinical development of vaccine for Alzheimer's disease, Hypertension and Fertility management.

Resources