Evaluation of Covid-19 vaccines: Pharmacoepidemiological aspects.

Thérapie
Antoine Pariente, Julien Bezin

Abstract

The marketing authorization granted to SARS-Cov-2 vaccines was accompanied by reinforced safety monitoring plans. These plans' implementation was part of the usual logic of post-marketing surveillance of new and innovative health products. It was especially adapted to the context of post-marketing monitoring of drugs developed according to the usual scientific quality standards but in an accelerated schedule. In Europe, the reinforced surveillance system relies on the complementary strengths of pharmacovigilance and pharmacoepidemiology. If the performances of pharmacovigilance monitoring are incomparable for the detection of safety signals relating to rare events of atypical presentation, it needs to be completed with pharmacoepidemiology activities for more common events, either multifactorial or frequently classified as idiopathic. The pharmacoepidemiological monitoring developed in Europe was elaborated before the first SARS-Cov-2 vaccines where marketed, taking into account the lessons learned from the vaccination campaign against 2009 A (H1N1) influenza. It includes numerous academic studies as well as studies performed within vaccines risk management plans. In terms of safety, those defined a priori mostly concerns a lis...Continue Reading

References

Jul 26, 2013·Brain : a Journal of Neurology·Yves DauvilliersUNKNOWN Narcoflu-VF study group
Dec 10, 2014·International Journal of Clinical Pharmacy·Vaishali K PatadiaGianluca Trifirò
Sep 16, 2015·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Alexandra C PacurariuPreciosa M Coloma
Apr 16, 2016·Thérapie·Jean-Luc FaillieAntoine Pariente
Mar 2, 2019·Thérapie·Agnès Sommet, Antoine Pariente
Feb 25, 2021·The New England Journal of Medicine·Noa DaganRan D Balicer
Apr 3, 2021·Lancet·Søren Dinesen ØstergaardHenrik Toft Sørensen
Jun 2, 2021·Thérapie·Clémence LacroixUNKNOWN French Network of Pharmacovigilance Centres

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Citations

Jun 14, 2021·Thérapie·Jean-Louis MontastrucAgnès Sommet
Jun 14, 2021·Thérapie·Mathieu MolimardJean-Luc Cracowski

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Software Mentioned

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