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European Pharmaceutical Students’ Association
Efficacy and safety of COVID-19 vaccines: An overlook of a pandemic vaccine development landscape Author: Bruno Miguel da Silva Casquilho Alves Scientific Coordinator: Ana Paula Martins, Assistant Professor with Habilitation, Phd, Diana Costa, PharmD, Msc Institution: Faculty of Pharmacy of the University of Lisbon
INTRODUCTION: As soon as COVID-19 became a public health emergency, the race was on to develop vaccines of robust quality, safety and efficacy that could provide an important arsenal to prevent the spread of the virus or the development of the symptoms associated with its infection. With global society paralyzed, it was of everyone’s interest that the process of developing, evaluating and distributing these vaccines was as fluid as possible. AIM: This report focuses on the safety and efficacy evaluation process of the vaccines that have been approved until July, 2021, for the EU, analytically comparing the results obtained. It also addresses all the measures that have been adopted to speed up the availability of these vaccine technologies to the public. Additionally, it contains a historical contextualization of the evolution of scientific research on coronaviruses and a multidisciplinary approach to the molecular structure and epidemiology of SARS-CoV2. It aims to provide the public with clear and robust information on COVID-19 vaccines. MATERIAL AND METHODS: To achieve the proposed objectives, a literature review was conducted. Data collection was supported by scientific articles, collected through research in platforms such as PubMed and Google Scholar. In particular, the EMA and European Commission websites were consulted. EMA Public Assessment Reports were consulted as a basis for the study of the safety and efficacy assessment processes of vaccines approved in the European Union. RESULTS AND CONCLUSION: It was possible to analyze the adaptations performed by EMA in their vaccine assessment process, concluding that the development of vaccines
has the same requirements as other medicines to establish a favorable benefit/risk ratio for market authorization. Additionally, it was possible to understand in depth the way all the background research in the coronavirus field has enhanced the rapid discovery of strategic therapeutic targets and a better understanding of the pathophysiological mechanisms of SARS-CoV-2. Additionally, a comparative analysis was established between the clinical trials of the different vaccines approved in the European Union. This data will be used for further study, in order to verify if the clinical results correspond to the behavior seen in the real-world population.
