Title :

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

Author(s) :

Valnet-Rabier, Marie-Blanche [Auteur]
Centre Hospitalier Régional Universitaire de Besançon [CHRU Besançon]
Tebacher, Martine [Auteur]
Les Hôpitaux Universitaires de Strasbourg [HUS]
Gautier, Sophie [Auteur]
Centre Régional de PharmacoVigilance Nord-Pas-de-Calais [CHU Lille] [CRPV]
Lille Neurosciences & Cognition (LilNCog) - U 1172
Micallef, Joelle [Auteur]
Service de Pharmacologie Clinique [Hôpital de la Timone - APHM]
Salvo, Francesco [Auteur]
Bordeaux population health [BPH]
Pariente, Antoine [Auteur]
Bordeaux population health [BPH]
Département Hospitalo-Universitaire de Pharmacologie de Bordeaux
Bagheri, Haleh [Auteur]
Centre Régional de PharmacoVigilance [CHU Toulouse] [CRPV]

Journal title :

Therapies

Volume number :

78

Pages :

499-507

Publication date :

2023-04-04

ISSN :

1958-5578

HAL domain(s) :

Sciences du Vivant [q-bio]/Santé publique et épidémiologie

English abstract : [en]

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 ...
Show more >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.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Lille Neurosciences & Cognition (LilNCog) - U 1172

Submission date :

2024-01-15T23:12:00Z
2024-05-24T07:49:06Z