Risk for Myocardial Infarction, Stroke, and Pulmonary Embolism Following COVID-19 Vaccines in Adults Younger Than 75 Years in France.

Autor:	Botton J; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France, and Faculté de Pharmacie, Université Paris-Saclay, Châtenay-Malabry, France (J.B.)., Jabagi MJ; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France (M.J.J., M.B., B.B., J.D., S.L.V., A.W., R.D.)., Bertrand M; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France (M.J.J., M.B., B.B., J.D., S.L.V., A.W., R.D.)., Baricault B; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France (M.J.J., M.B., B.B., J.D., S.L.V., A.W., R.D.)., Drouin J; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France (M.J.J., M.B., B.B., J.D., S.L.V., A.W., R.D.)., Le Vu S; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France (M.J.J., M.B., B.B., J.D., S.L.V., A.W., R.D.)., Weill A; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France (M.J.J., M.B., B.B., J.D., S.L.V., A.W., R.D.)., Farrington P; School of Mathematics and Statistics, The Open University, Milton Keynes, United Kingdom (P.F.)., Zureik M; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France, and University Paris-Saclay, UVSQ, Univ. Paris-Sud, Inserm, Anti-infective evasion and pharmacoepidemiology, CESP, Montigny le Bretonneux, France (M.Z.)., Dray-Spira R; EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France (M.J.J., M.B., B.B., J.D., S.L.V., A.W., R.D.).
Jazyk:	angličtina
Zdroj:	Annals of internal medicine [Ann Intern Med] 2022 Sep; Vol. 175 (9), pp. 1250-1257. Date of Electronic Publication: 2022 Aug 23.
DOI:	10.7326/M22-0988
Abstrakt:	Background: The BNT162b2 (Pfizer-BioNTech) vaccine has been shown to be safe with regard to risk for severe cardiovascular events (such as myocardial infarction [MI], pulmonary embolism [PE], and stroke) in persons aged 75 years or older. Less is known about the safety of other COVID-19 vaccines or outcomes in younger populations. Objective: To assess short-term risk for severe cardiovascular events (excluding myocarditis and pericarditis) after COVID-19 vaccination in France's 46.5 million adults younger than 75 years. Design: Self-controlled case series method adapted to event-dependent exposure and high event-related mortality. Setting: France, 27 December 2020 to 20 July 2021. Patients: All adults younger than 75 years hospitalized for PE, acute MI, hemorrhagic stroke, or ischemic stroke ( n  = 73 325 total events). Measurements: Linkage between the French National Health Data System and COVID-19 vaccine databases enabled identification of hospitalizations for cardiovascular events (MI, PE, or stroke) and receipt of a first or second dose of the Pfizer-BioNTech, mRNA-1273 (Moderna), Ad26.COV2.S (Janssen), or ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vaccine. The relative incidence (RI) of each cardiovascular event was estimated in the 3 weeks after vaccination compared with other periods, with adjustment for temporality (7-day periods). Results: No association was found between the Pfizer-BioNTech or Moderna vaccine and severe cardiovascular events. The first dose of the Oxford-AstraZeneca vaccine was associated with acute MI and PE in the second week after vaccination (RI, 1.29 [95% CI, 1.11 to 1.51] and 1.41 [CI, 1.13 to 1.75], respectively). An association with MI in the second week after a single dose of the Janssen vaccine could not be ruled out (RI, 1.75 [CI, 1.16 to 2.62]). Limitations: It was not possible to ascertain the relative timing of injection and cardiovascular events on the day of vaccination. Outpatient deaths related to cardiovascular events were not included. Conclusion: In persons aged 18 to 74 years, adenoviral-based vaccines may be associated with increased incidence of MI and PE. No association between mRNA-based vaccines and the cardiovascular events studied was observed. Primary Funding Source: None.
Databáze:	MEDLINE
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