Benefit/risk assessment of SARS-CoV-2 vaccines approved in the European Union

Abstract

The pandemic caused by SARS-CoV-2 has produced a significant impact on health, especially among elderly individuals and those with pre-existing health problems. The development of prophylactic vaccines has been urgently needed to combat the pandemic caused by this virus. Therefore, vaccines against SARS-COV-2 have been developed at an unprecedented speed. It has become essential to evaluate and compare the efficacy and safety of these vaccines as soon as possible and that has been the objective of this work. For this purpose, a literature search was performed in sources and databases such as Pubmed, Google Scholar, European Medicines Agency (EMA) and Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) until December 2021. The pivotal trials of all vaccines approved by the EMA (those used by the regulatory agencies for authorization and the basis of the technical datasheet) have been analyzed (ComirnatyBioNTech-Pzifer, COVID-19 Vaccine Moderna, Vaxzevria or AstraZeneca and COVID-19 Vaccine Janssen).