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Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran)

INTRODUCTION: Two severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines, tozinameran/BNT162b2 (Comirnaty®, Pfizer-BioNTech) and elasomeran/mRNA-1273 (Spikevax®, Moderna), were approved by the Food and Drug Administration (FDA) and the European Medicines Agency (E...

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Autores principales: Valnet-Rabier, Marie-Blanche, Tebacher, Martine, Gautier, Sophie, Micallef, Joelle, Salvo, Francesco, Pariente, Antoine, Bagheri, Haleh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10007713/
https://www.ncbi.nlm.nih.gov/pubmed/37012149
http://dx.doi.org/10.1016/j.therap.2023.03.005
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author Valnet-Rabier, Marie-Blanche
Tebacher, Martine
Gautier, Sophie
Micallef, Joelle
Salvo, Francesco
Pariente, Antoine
Bagheri, Haleh
author_facet Valnet-Rabier, Marie-Blanche
Tebacher, Martine
Gautier, Sophie
Micallef, Joelle
Salvo, Francesco
Pariente, Antoine
Bagheri, Haleh
author_sort Valnet-Rabier, Marie-Blanche
collection PubMed
description INTRODUCTION: Two severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines, tozinameran/BNT162b2 (Comirnaty®, Pfizer-BioNTech) and elasomeran/mRNA-1273 (Spikevax®, Moderna), were approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) at the end of 2020, less than a year after the start of the coronavirus disease 2019 (COVID-19) pandemic. In France, the health authorities have requested an intensive vaccination campaign, accompanied by a reinforced and active pharmacovigilance surveillance. This surveillance and analysis of real-life data, based on spontaneous reports received by the French Network of Regional PharmacoVigilance Centers (RFCRPV), has enabled to identify numerous pharmacovigilance signals. Some of them, such as myocarditis and heavy menstrual bleeding, have been confirmed as adverse effects of these vaccines. METHOD: We propose a descriptive review of the main pharmacovigilance signals identified by the RFCRPV concerning vaccines from the mRNA platform. RESULTS: Most pharmacovigilance signals were common to both mRNA vaccines: myocarditis, menstrual disorders, acquired haemophilia, Parsonage-Turner syndrome, rhizomelic pseudo-polyarthritis and hearing disorders. Other signals were more specific, such as arterial hypertension with tozinameran or delayed reaction site injection with elasomeran. CONCLUSION: This non-exhaustive review illustrates the experience of RFCRPV in identifying and monitoring pharmacovigilance signals related to mRNA vaccines in France during the COVID-19 pandemics, and the crucial role of pharmacological and clinical expertise in this area. It also highlights the predominant contribution of spontaneous reporting in the generation of pharmacovigilance signals, particularly for serious and rare adverse events not detected before marketing.
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spelling pubmed-100077132023-03-13 Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran) Valnet-Rabier, Marie-Blanche Tebacher, Martine Gautier, Sophie Micallef, Joelle Salvo, Francesco Pariente, Antoine Bagheri, Haleh Therapie Pharmacovigilance INTRODUCTION: Two severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines, tozinameran/BNT162b2 (Comirnaty®, Pfizer-BioNTech) and elasomeran/mRNA-1273 (Spikevax®, Moderna), were approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) at the end of 2020, less than a year after the start of the coronavirus disease 2019 (COVID-19) pandemic. In France, the health authorities have requested an intensive vaccination campaign, accompanied by a reinforced and active pharmacovigilance surveillance. This surveillance and analysis of real-life data, based on spontaneous reports received by the French Network of Regional PharmacoVigilance Centers (RFCRPV), has enabled to identify numerous pharmacovigilance signals. Some of them, such as myocarditis and heavy menstrual bleeding, have been confirmed as adverse effects of these vaccines. METHOD: We propose a descriptive review of the main pharmacovigilance signals identified by the RFCRPV concerning vaccines from the mRNA platform. RESULTS: Most pharmacovigilance signals were common to both mRNA vaccines: myocarditis, menstrual disorders, acquired haemophilia, Parsonage-Turner syndrome, rhizomelic pseudo-polyarthritis and hearing disorders. Other signals were more specific, such as arterial hypertension with tozinameran or delayed reaction site injection with elasomeran. CONCLUSION: This non-exhaustive review illustrates the experience of RFCRPV in identifying and monitoring pharmacovigilance signals related to mRNA vaccines in France during the COVID-19 pandemics, and the crucial role of pharmacological and clinical expertise in this area. It also highlights the predominant contribution of spontaneous reporting in the generation of pharmacovigilance signals, particularly for serious and rare adverse events not detected before marketing. Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. 2023-03-11 /pmc/articles/PMC10007713/ /pubmed/37012149 http://dx.doi.org/10.1016/j.therap.2023.03.005 Text en © 2023 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Pharmacovigilance
Valnet-Rabier, Marie-Blanche
Tebacher, Martine
Gautier, Sophie
Micallef, Joelle
Salvo, Francesco
Pariente, Antoine
Bagheri, Haleh
Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran)
title Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran)
title_full Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran)
title_fullStr Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran)
title_full_unstemmed Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran)
title_short Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran)
title_sort pharmacovigilance signals from active surveillance of mrna platform vaccines (tozinameran and elasomeran)
topic Pharmacovigilance
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10007713/
https://www.ncbi.nlm.nih.gov/pubmed/37012149
http://dx.doi.org/10.1016/j.therap.2023.03.005
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