30 mars 2023
Despite the alert launched across the Atlantic, no risk of cardiovascular event has been associated with bivalent mRNA vaccines from Pfizer & BioNTech in people over 50 years of age. This is the finding of a French EPI-PHARE study, published in the New England Journal of Medicine.
No, bivalent mRNA vaccines against Covid-19 do not increase the risk of a serious cardiovascular event compared to monovalent mRNA vaccines. Which are not associated with a risk of serious cardiovascular events (excluding myocarditis). It is a pharmacoepidemiology study conducted by the ANSM-Cnam scientific interest group in the epidemiology of EPI-PHARE health products that is reassuring on this subject.
Unverified US Alert
This recent work was undertaken following the announcement in January 2023, by the Food and Drug Administration and the Vaccine Safety Datalink des Centers for Disease Control and Prevention Americans, of an increased risk of ischemic stroke within 21 days following administration of the bivalent Comirnaty* vaccine in people aged 65 and over.
Covering vaccinations administered in France between October 6 and November 9, 2022, the study included a total of 470,962 people, of whom 20.6% had received the monovalent vaccine and 79.4% one of the bivalent vaccines. . “No increased risk of ischemic stroke, hemorrhagic stroke, myocardial infarction, pulmonary embolism, or any of the four events combined could be demonstrated within 21 days of administration of a bivalent vaccine Comirnaty in comparison with the administration of the monovalent vaccine »note the authors.
As a result, “ the continued use of bivalent mRNA vaccines against Covid-19 is supported by these reassuring results”they conclude.
To note : Since the end of 2022 in France, three mRNA vaccines developed by Pfizer/BioNtech laboratories can be used as a booster in children aged 12 and over: a monovalent vaccine targeting only the original SARS-CoV-2, a bivalent vaccine targeting SARS-CoV -2 and the Omicron BA.1 subline and a bivalent vaccine targeting the original SARS-CoV-2 and the BA.4 and BA.5 subvariants.
*Pfizer & BioNTech