A prospective study on myocardial injury after BNT162b2 mRNA COVID‐19 fourth dose vaccination in healthy persons. (28th September 2022)

• Record Type: Journal Article
• Authors: Levi, Nir; Moravsky, Gil; Weitsman, Tatyana; Amsalem, Itshak; Bar‐Sheshet Itach, Sarit; Algur, Nurit; Lapidus, Ira; Mitz, Ofir; Glikson, Michael; Wiener‐Well, Yonit; Hasin, Tal
• Is Part Of: European journal of heart failure. Volume 25:Number 2(2023)
• Page Start: 313
• Page End: 318
• Publication Date: 2022-09-28
• Subjects: COVID‐19 -- mRNA -- Myocardial injury -- Myocarditis -- Vaccine; Heart failure -- Periodicals; Heart Failure -- Periodicals; Insuffisance cardiaque -- Périodiques; Heart failure; Periodicals; 616.129005
• DOI: 10.1002/ejhf.2687
• Languages: English
• ISSNs: 1388-9842

Abstract

Abstract : Aims: To prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer‐BioNTech) against COVID‐19. Methods and results: Health care workers who received the BNT162b2 vaccine during the fourth dose campaign had blood samples collected for high‐sensitivity cardiac troponin (hs‐cTn) during vaccine administration and 2–4 days afterward. Vaccine‐related myocardial injury was defined as hs‐cTn elevation above the 99th percentile upper reference limit and >50% increase from baseline measurement. Participants with evidence of myocardial injury underwent assessment for possible myocarditis. Of 324 participants, 192 (59.2%) were female and the mean age was 51.8 ± 15.0 years. Twenty‐one (6.5%) participants had prior COVID‐19 infection, the mean number of prior vaccine doses was 2.9 ± 0.4, and the median time from the last dose was 147 (142–157) days. Reported vaccine‐related adverse reactions included local pain at injection site in 57 (17.59%), fatigue in 39 (12.04%), myalgia in 32 (9.88%), sore throat in 21 (6.48%), headache in 18 (5.5%), fever ≥38°C in 16 (4.94%), chest pain in 12 (3.7%), palpitations in 7 (2.16%), and shortness of breath in one (0.3%) participant. Vaccine‐related myocardial injury was demonstrated in two (0.62%) participants, one had mild symptoms and one was asymptomatic; both had a normal electrocardiogram and echocardiography. Conclusion: In a prospective investigation, an increase in serum troponin levels was documented among 0.62% of healthy health care workers receiving the fourth dose BNT162b2 vaccine. The two cases had mild or no symptoms and no clinical sequela. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT05308680. Abstract : An association between the administration of mRNA vaccines against COVID‐19 and myocarditis was well established in large population‐based retrospective studies. In this prospective study, health care workers who received the fourth dose of the BNT162b2 (Pfizer‐BioNTech) vaccine had blood samples collected for high‐sensitivity cardiac troponin (hs‐cTn) before and 2–4 days after vaccine administration. Of 324 recipients, 2 (0.62%) were found to have a vaccine‐related myocardial injury; both had a normal electrocardiogram (ECG) and left ventricular ejection fraction on echocardiography. CMR, cardiovascular magnetic resonance; LVEF, left ventricular ejection fraction. *CMR was performed based on a clinical indication in one recipient.