Saudi Cultural Missions Theses & Dissertations
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Item Restricted Improving and Characterising Influenza and COVID-19 vaccines(University of Sydney, 2023-10-19) Alharbi, Abdulsalam Abdullah; Kayser, VeyselThe development of safe and effective vaccinations against infectious illnesses and certain cancers that cause substantial morbidity and death is a major advancement in medicine. Vaccination, as a preventative public health measure, has clearly led to better health outcomes for people all over the globe. It is believed that vaccinations have prevented six million deaths every year (1). The need of developing a strong vaccination plan for global immunisation has been reaffirmed in the light of the COVID-19 pandemic. Safe and effective vaccines can only be developed with persistent characterisation and stable formulations. In addition, efforts are made to find solutions to problems like preserving cold chains, which are essential for keeping vaccines at their peak potency and efficacy throughout storage and shipping. The first chapter provides a general introduction to vaccinations and their background, as well as a brief synopsis of the other chapters, each of which is dedicated to one of three goals. In Chapter 2, we go deeply and exhaustively into a variety of flu-related topics (viruses and vaccines). The thesis's three aims are discussed in the following chapters. The primary objective was to find a suitable replacement for Triton X-100, which is currently used as a splitting agent in the manufacturing of split-virus influenza vaccines but is considered a "substance of very high concern" by the European Commission due to the production of harmful metabolites upon its environmental release. In Chapter 3, we see the results of an experimental study introducing an alternative to Triton X-100 that shows promise for use in the manufacturing of inactivated influenza vaccines. The second goal of this research was to conduct the first-ever evaluation of the capacity of macrocycles to stabilise influenza virus (chapter 4). Despite macrocycles' widespread use in the pharmaceutical industry, the potential of these structures to improve influenza vaccine formulations has not been investigated until recently. The third goal of this study was to investigate the effects of the stabiliser sCX[4] on the thermal stability and aggregation properties of two different COVID-19 vaccine formulations (from Pfizer and AstraZeneca). This study set out to explain how sCX[4] affects the stability and aggregation behaviour of COVID-19 vaccine formulations. This thesis presents novel experimental approaches that may improve and speed up the process of creating vaccines against influenza and COVID-19. These results help advance scientific knowledge and provide crucial insight for the development of future influenza and COVID-19 vaccines, which will assist public health initiatives throughout the world.16 0Item Restricted Review times and clinical evidence on COVID-19 Vaccine Approvals in the US Food and Drug Administration and European Union” EMA”(Massachusetts University, 2024) Abu Rukbah, Walaa Saad; Mekary, RaniaBackground: Medication approval procedures have undergone streamlining by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This study identifies discrepancies in evidence supplied, comparing the review times and regulations of drugs licensed by both agencies. Objective: To compare the alignment of review outcomes between the EMA and FDA for medicines approved by both agencies from 2020 to 2022. Design: By examining the FDA and EMA websites, all COVID-19 vaccines licensed from December 2020 to January 2022 were identified. Publicly available information from the FDA and EMA websites determined the COVID-19 vaccines approved by each agency. Results: In 2020-2022, the FDA licensed 3 vaccines, while the EMA licensed 5. The median review time is typically shorter in the FDA than in the EMA. Differences in regulations and processes for COVID-19 vaccines submitted to the two regulators were identified. Conclusion: The median review time for COVID-19 vaccines approved by both agencies was similar. Despite differences in regulations and processes due to the pandemic, both the FDA and EMA share the common goal of ensuring safety and efficacy.36 0