Safety of COVID-19 vaccines administered in the EU: Should we be concerned?
Metadatos
Mostrar el registro completo del ítemEditorial
ELSEVIER
Materia
COVID-19 Vaccines Safety Side effects Thrombosis Clinical trials Public health
Fecha
2021Referencia bibliográfica
Hernández, A. F., Calina, D., Poulas, K., Docea, A. O., & Tsatsakis, A. M. (2021). Safety of COVID-19 vaccines administered in the EU: Should we be concerned?. Toxicology Reports, 8, 871-879. [DOI: 10.1016/j.toxrep.2021.04.003]
Resumen
The COVID-19 pandemic has had an unprecedented and devastating impact on public health, society and economics around the world. As a result, the development of vaccines to protect individuals from symptomatic
COVID-19 infections has represented the only feasible health tool to combat the spread of the disease. However,
at the same time the development and regulatory assessment of different vaccines has challenged pharmaceutical
industries and regulatory agencies as this process has occurred in the shorter time ever though. So far, two mRNA
and two adenovirus-vectored vaccines have received a conditional marketing authorisation in the EU and other
countries. This review summarized and discusses the assessment reports of the European Medicine Agency (EMA)
concerning the safety of the 3 vaccines currently used in the EU (Pfizer, Moderna and Astra-Zeneca). A particular
focus has been paid to safety information from pre-clinical (animal) and clinical (phase 3 trials) studies. Overall,
the most frequent adverse effects reported after the administration of these vaccines consisted of local reactions
at the injection site (sore arm and erythema) followed by non-specific systemic effects (myalgia, chills, fatigue,
headache, and fever), which occurred soon after vaccination and resolved shortly. Rare cases of vaccine-induced
immune thrombotic thrombocytopenia have been reported for Vaxzevria. Data on long-term studies, interaction
with other vaccines, use in pregnancy/breast-feeding, use in immunocompromised subjects, and in subjects with
comorbidities, autoimmune or inflammatory disorders are still missing for these vaccines. Therefore, careful
follow-up and surveillance studies for continued vaccine safety monitoring will be needed to ascertain the potential risks of such adverse events or diseases. In conclusion, the benefits and risks of current COVID-19 vaccines
must be weighed against the real possibility of contract the disease and develop complications and long-term
sequels; all this on the basis of the available scientific evidence and in the absence of unmotivated biases.