A Pharmacoepidemiological Study of Myocarditis and Pericarditis Following the First Dose of mRNA COVID-19 Vaccine in Europe

被引:0
作者
Tome, Joana [1 ]
Cowan, Logan T. [1 ]
Fung, Isaac Chun-Hai [1 ]
机构
[1] Georgia Southern Univ, Jiann Ping Hsu Coll Publ Hlth, Dept Biostat Epidemiol & Environm Hlth Sci, Statesboro, GA 30458 USA
关键词
COVID-19; adverse drug reaction; myocarditis; pericarditis; COVID-19 mRNA vaccine;
D O I
10.3390/microorganisms11051099
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
This study assessed the myocarditis and pericarditis reporting rate of the first dose of mRNA COVID-19 vaccines in Europe. Myocarditis and pericarditis data pertinent to mRNA COVID-19 vaccines (1 January 2021-11 February 2022) from EudraVigilance database were combined with European Centre for Disease Prevention and Control (ECDC)'s vaccination tracker data. The reporting rate was expressed as events (occurring within 28 days of the first dose) per 1 million individuals vaccinated. An observed-to-expected (OE) analysis quantified excess risk for myocarditis or pericarditis following the first mRNA COVID-19 vaccination. The reporting rate of myocarditis per 1 million individuals vaccinated was 17.27 (95% CI, 16.34-18.26) for CX-024414 and 8.44 (95% CI, 8.18-8.70) for TOZINAMERAN; and of pericarditis, 9.76 (95% CI, 9.06-10.51) for CX-024414 and 5.79 (95% CI, 5.56-6.01) for TOZINAMERAN. Both vaccines produced a myocarditis standardized morbidity ratio (SMR) > 1, with the CX-024414 vaccine having a greater SMR than TOZINAMERAN. Regarding TOZINAMERAN, SMR for pericarditis was >1 when considering the lowest background incidence, but <1 when considering the highest background incidence. Our results suggest an excess risk of myocarditis following the first dose of the mRNA COVID-19 vaccine, but the relationship between pericarditis and the mRNA COVID-19 vaccine remains unclear.
引用
收藏
页数:12
相关论文
共 34 条
[1]   Comparison of adverse drug reactions among four COVID-19 vaccines in Europe using the EudraVigilance database: Thrombosis at unusual sites [J].
Abbattista, Maria ;
Martinelli, Ida ;
Peyvandi, Flora .
JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2021, 19 (10) :2554-2558
[2]  
[Anonymous], adverse drug reaction reports of antineoplastics in our hos
[3]   Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting [J].
Barda, Noam ;
Dagan, Noa ;
Ben-Shlomo, Yatir ;
Kepten, Eldad ;
Waxman, Jacob ;
Ohana, Reut ;
Hernan, Miguel A. ;
Lipsitch, Marc ;
Kohane, Isaac ;
Netzer, Doron ;
Reis, Ben Y. ;
Balicer, Ran D. .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 385 (12) :1078-1090
[4]   Myocarditis With COVID-19 mRNA Vaccines [J].
Bozkurt, Biykem ;
Kamat, Ishan ;
Hotez, Peter J. .
CIRCULATION, 2021, 144 (06) :471-484
[5]   Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination: What Do We Know So Far? [J].
Das, Bibhuti B. ;
Moskowitz, William B. ;
Taylor, Mary B. ;
Palmer, April .
CHILDREN-BASEL, 2021, 8 (07)
[6]   Myocarditis and Pericarditis After Vaccination for COVID-19 [J].
Diaz, George A. ;
Parsons, Guilford T. ;
Gering, Sara K. ;
Meier, Audrey R. ;
Hutchinson, Ian V. ;
Robicsek, Ari .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2021, 326 (12) :1210-1212
[7]  
European Centre for Disease Prevention and Control, DAT COVID 19 VACC EU
[8]  
European Medicines Agency, COVID 19 VACC UPD ON
[9]  
European Medicines Agency Pharmacovigilance Risk Assessment Committee, 2021, SIGN ASS REP MYOC PE
[10]  
Gargano JW, 2021, MMWR-MORBID MORTAL W, V70, P977, DOI 10.15585/mmwr.mm7027e2