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.

Questions & answers

Please, tell us a little bit more about yourself. My name is Bruno Alves, I’m 22 years old and I’m a 4th year MPharm student at the Faculty of Pharmacy, University of Lisbon. I have been actively involved in a series of extracurricular projects, namely in associativism, being currently President of APEF, Portugal. In my third year, I started a cycle of public health research projects in the area of vaccines, so I hope to grow academically and be able to use my findings for my professional future.

Tell us a bit more about your research and its significance. My project was started in 2020, when the pandemic was at its peak. Vaccines were in the development phase, and the population had many questions about how they worked and how their safety and efficacy was being ensured. In order to create scientific content that would answer these questions, I decided to embark on a series of projects that would cover the different phases of vaccine development, from clinical evaluation to pharmacovigilance.

What was the biggest challenge while carrying out the research and how did you overcome that? No doubt the schematization of project topics. It was a very abstract period of time in which I was reading a lot of literature without knowing what I was going to do with it. It was crucial to systematise all the data and ensure an organised archive of it, in order to achieve a fruitful systematic analysis. With the topics defined, the research and writing work became much simpler. In your opinion, what is the benefit of joining ESSP and what advice do you have for students undertaking research in the future? I really believe it is an asset to communicate science projects with other students. I believe I grew in terms of critical thinking, scientific awareness, and work organisation. My main advice: don’t stop being ambitious in searching for answers to your questions. That’s what research is all about, and there are never any silly questions. Together, we can add value in health, and make research a noble activity for the population.