Safety of COVID-19 vaccines administered in the EU: Should we be concerned?
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 t...
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doaj-5875c6d44664497aad9ee9690cbf019c2021-04-22T13:38:54ZengElsevierToxicology Reports2214-75002021-01-018871879Safety of COVID-19 vaccines administered in the EU: Should we be concerned?Antonio F. Hernández0Daniela Calina1Konstantinos Poulas2Anca Oana Docea3Aristidis M. Tsatsakis4Department of Legal Medicine and Toxicology, University of Granada School of Medicine, Granada, Spain; Instituto de Investigación Biosanitaria, Granada (ibs.GRANADA), Spain; Corresponding author at: Department of Legal Medicine and Toxicology, University of Granada School of Medicine, Granada, Spain.Department of Clinical Pharmacy, University of Medicine and Pharmacy of Craiova, 200349, Craiova, RomaniaLaboratory of Molecular Biology and Immunology, Department of Pharmacy, University of Patras, Panepistimiopolis, 26500 Rio-Patras, GreeceDepartment of Toxicology, University of Medicine and Pharmacy of Craiova, 200349, Craiova, RomaniaDepartment of Forensic Sciences and Toxicology, Faculty of Medicine, University of Crete, 71003, Heraklion, GreeceThe 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.http://www.sciencedirect.com/science/article/pii/S2214750021000792Covid-19VaccinesSafetySide effectsThrombosisClinical trials |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Antonio F. Hernández Daniela Calina Konstantinos Poulas Anca Oana Docea Aristidis M. Tsatsakis |
spellingShingle |
Antonio F. Hernández Daniela Calina Konstantinos Poulas Anca Oana Docea Aristidis M. Tsatsakis Safety of COVID-19 vaccines administered in the EU: Should we be concerned? Toxicology Reports Covid-19 Vaccines Safety Side effects Thrombosis Clinical trials |
author_facet |
Antonio F. Hernández Daniela Calina Konstantinos Poulas Anca Oana Docea Aristidis M. Tsatsakis |
author_sort |
Antonio F. Hernández |
title |
Safety of COVID-19 vaccines administered in the EU: Should we be concerned? |
title_short |
Safety of COVID-19 vaccines administered in the EU: Should we be concerned? |
title_full |
Safety of COVID-19 vaccines administered in the EU: Should we be concerned? |
title_fullStr |
Safety of COVID-19 vaccines administered in the EU: Should we be concerned? |
title_full_unstemmed |
Safety of COVID-19 vaccines administered in the EU: Should we be concerned? |
title_sort |
safety of covid-19 vaccines administered in the eu: should we be concerned? |
publisher |
Elsevier |
series |
Toxicology Reports |
issn |
2214-7500 |
publishDate |
2021-01-01 |
description |
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. |
topic |
Covid-19 Vaccines Safety Side effects Thrombosis Clinical trials |
url |
http://www.sciencedirect.com/science/article/pii/S2214750021000792 |
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