NEW STUDY

July 26, 2023 171 Views

Myocardial Injury after COVID-19 mRNA-1273 Booster Vaccination   STUDY

 

Department of Cardiology and Cardiovascular Research Institute Basel (ESC Heart Failure, open-access journal of the Heart Failure Association of the European Society of Cardiology)

 

Prospective active surveillance study (Not a retrospective passive surveillance study) Industry independent, instigated by the investigators Aims Incidence and potential mechanisms of oligosymptomatic myocardial injury, following COVID-19 mRNA booster vaccination.

 

Safety net for those already boosted, screening and prevention of complications Methods and Results December 2021 to February 2022 Hospital employees scheduled to undergo mRNA-1273 booster vaccination, assessed for mRNA-1273 vaccination-associated myocardial injury, defined as acute dynamic increase in high-sensitivity cardiac troponin T (hs-cTnT) concentration, above the sex-specific upper-limit of normal on day 3 (48-96h) after vaccination without evidence of an alternative cause. 777 participants Median age 37 years, 69.5% women 40 participants (5.1%) had elevated high-sensitivity cardiac troponin T concentration on day 3 (Taken as above the 99th percentile for age and sex) mRNA-1273 vaccine-associated myocardial injury was adjudicated in 22 participants (2.8%). One in 35 recipients (2.8%) had vaccine-associated myocardial injury Of the 777, 2 women had chest pain Of these 22 cases with mRNA-1273 vaccine-associated myocardial injury Twenty cases occurred in women Two in men Hs-cTnT-elevations were mild and only temporary. No patient had ECG- changes, none developed major adverse cardiac events within 30 days In the overall booster cohort hs-cTnT concentrations, on day 3 Median 5 ng/L, IQR, 4-6 Matched controls (n=777), 3 ng/L IQR, 3-5 Significantly higher p less than 0.001 (If elevated on day3, given warning, investigations and advice) No MACE (major adverse cardiac events) within 30 days Cases had comparable systemic reactogenicity Concentrations of cytokines and cytokine antagonists were markers quantifying systemic inflammation Lower concentrations GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) induces the development of monocytes, neutrophils, eosinophils, and myeloid and dermal dendritic cells. IFN- λ1(IL-29) a group of anti-viral cytokines, that consists of four IFN-λ molecules Conclusion mRNA-1273 vaccine-associated myocardial injury was more common than previously thought, being mild and transient, and more frequent in women versus men. The possible protective role of IFN-λ1(IL-29) and GM-CSF warrant further studies.

 

Similar Pfizer studies – A prospective study on myocardial injury after BNT162b2 mRNA COVID-19 fourth dose vaccination in healthy persons https://pubmed.ncbi.nlm.nih.gov/36097…

A prospective study on myocardial injury after BNT162b2 mRNA COVID-19 fourth dose vaccination in healthy persons https://onlinelibrary.wiley.com/doi/1…\

NZ Pfizer add https://www.everydayheroestakeaction….

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