tetano
Editor, Senior Moderator
Therapie
. 2024 Nov 14:S0040-5957(24)00199-9.
doi: 10.1016/j.therap.2024.11.002. Online ahead of print. The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report
Samuel Crommelynck[SUP] 1 [/SUP], Aurélie Grandvuillemin[SUP] 2 [/SUP], Claire Ferard[SUP] 3 [/SUP], Céline Mounier[SUP] 3 [/SUP], Nathalie Gault[SUP] 4 [/SUP], Evelyne Pierron[SUP] 3 [/SUP], Baptiste Jacquot[SUP] 3 [/SUP], Tiphaine Vaillant[SUP] 4 [/SUP], Isabelle Parent du Chatelet[SUP] 5 [/SUP], Alexis Jacquet[SUP] 6 [/SUP], Francesco Salvo[SUP] 7 [/SUP], Martine Alt[SUP] 8 [/SUP], Haleh Bagheri[SUP] 9 [/SUP], Joëlle Micallef[SUP] 10 [/SUP], Antoine Pariente[SUP] 11 [/SUP], Sophie Gautier[SUP] 12 [/SUP], Marie-Blanche Valnet-Rabier[SUP] 13 [/SUP], Marina Atzenhoffer[SUP] 14 [/SUP], Marion Lepelley[SUP] 15 [/SUP], Judith Cottin[SUP] 16 [/SUP], Isabelle Lacroix[SUP] 17 [/SUP], Valérie Gras[SUP] 18 [/SUP], Nathalie Massy[SUP] 19 [/SUP], Alban Dhanani[SUP] 6 [/SUP], Philippe Vella[SUP] 6 [/SUP], Youssef Shaim[SUP] 6 [/SUP], Laurence Baril[SUP] 5 [/SUP], Annie-Pierre Jonville-Béra[SUP] 20 [/SUP], Mehdi Benkebil[SUP] 3 [/SUP]; 30 French Regional Pharmacovigilance Centres
Affiliations
In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres. Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed. Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed. The enhanced national PV system contributed actively better to define the safety profile of the newly developed vaccines, and the French National Agency for Medicines and Health Products Safety continues to monitor the benefit and risks of the COVID-19 vaccines.
Keywords: Adverse drug reaction; Benefit-risk assessment; COVID-19 vaccines; Enhanced surveillance; Pharmacovigilance; Safety signal.
. 2024 Nov 14:S0040-5957(24)00199-9.
doi: 10.1016/j.therap.2024.11.002. Online ahead of print. The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report
Samuel Crommelynck[SUP] 1 [/SUP], Aurélie Grandvuillemin[SUP] 2 [/SUP], Claire Ferard[SUP] 3 [/SUP], Céline Mounier[SUP] 3 [/SUP], Nathalie Gault[SUP] 4 [/SUP], Evelyne Pierron[SUP] 3 [/SUP], Baptiste Jacquot[SUP] 3 [/SUP], Tiphaine Vaillant[SUP] 4 [/SUP], Isabelle Parent du Chatelet[SUP] 5 [/SUP], Alexis Jacquet[SUP] 6 [/SUP], Francesco Salvo[SUP] 7 [/SUP], Martine Alt[SUP] 8 [/SUP], Haleh Bagheri[SUP] 9 [/SUP], Joëlle Micallef[SUP] 10 [/SUP], Antoine Pariente[SUP] 11 [/SUP], Sophie Gautier[SUP] 12 [/SUP], Marie-Blanche Valnet-Rabier[SUP] 13 [/SUP], Marina Atzenhoffer[SUP] 14 [/SUP], Marion Lepelley[SUP] 15 [/SUP], Judith Cottin[SUP] 16 [/SUP], Isabelle Lacroix[SUP] 17 [/SUP], Valérie Gras[SUP] 18 [/SUP], Nathalie Massy[SUP] 19 [/SUP], Alban Dhanani[SUP] 6 [/SUP], Philippe Vella[SUP] 6 [/SUP], Youssef Shaim[SUP] 6 [/SUP], Laurence Baril[SUP] 5 [/SUP], Annie-Pierre Jonville-Béra[SUP] 20 [/SUP], Mehdi Benkebil[SUP] 3 [/SUP]; 30 French Regional Pharmacovigilance Centres
Affiliations
- PMID: 39638686
- DOI: 10.1016/j.therap.2024.11.002
In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres. Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed. Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed. The enhanced national PV system contributed actively better to define the safety profile of the newly developed vaccines, and the French National Agency for Medicines and Health Products Safety continues to monitor the benefit and risks of the COVID-19 vaccines.
Keywords: Adverse drug reaction; Benefit-risk assessment; COVID-19 vaccines; Enhanced surveillance; Pharmacovigilance; Safety signal.