Cardiac Inflammation after COVID-19 mRNA Vaccines: A Global Pharmacovigilance Analysis

Abstract

Background To counter the COVID-19 pandemic, mRNA vaccines, namely tozinameran and elasomeran, have been authorized in several countries. These next generation vaccines have shown high efficacy against COVID-19 and demonstrated a favorable safety profile. As widespread vaccinations efforts are taking place, incidents of myocarditis and pericarditis cases following vaccination have been reported. This safety signal has been recently confirmed by the European Medicine Agency and the U.S. Food and Drug Administration. This study aimed to investigate and analyze this safety signal using a dual pharmacovigilance database analysis. Methods This is as an observational study of reports of inflammatory heart reactions associated with mRNA COVID-19 vaccines reported in the World Health Organization's global individual case safety report database (up to June 30th 2021), and in the U.S. Vaccine Adverse Event Reporting System (VAERS, up to May 21st 2021). Cases were described, and disproportionality analyses using reporting odds-ratios (ROR) and their 95% confidence interval (95%CI) were performed to assess relative risk of reporting according to patient sex and age. Results At a global scale, the inflammatory heart reactions most frequently reported were myocarditis (1241, 55%) and pericarditis (851, 37%), the majority requiring hospitalization (n=796 (64%)). Overall, patients were young (median age 33 [21-54] years). The main age group was 18-29 years old (704, 31%), and mostly males (1555, 68%). Pericarditis onset was delayed compared to myocarditis with a median time to onset of 8 [3-21] vs. 3 [2-6] days, respectively (p=0.001). Regarding myocarditis, an important disproportionate reporting in males (ROR, 9.4 [8.3-10.6]) as well as in adolescents (ROR, 22.3 [19.2-25.9]) and 18-29 years old (ROR, 6.6 [5.9-7.5]) compared to older patients were observed. Conclusions The inflammatory heart reactions, namely myocarditis and pericarditis, have been reported world-wide shortly following COVID-19 mRNA vaccination. An important disproportionate reporting among adolescents and young adults, particularly in males, was observed especially for myocarditis. Guidelines must take this specific risk into account and to optimize vaccination protocols according to sex and age. While the substantial benefits of COVID-19 vaccination still prevail over risks, clinicians and the public should be aware of these reactions and seek appropriate medical attention.

PQQ Supplementation and SARS-CoV-2 Spike Protein-Induced Heart Inflammation

“…SARS-CoV-2 spike protein-induced inflammations have been shown in many works 2 - 15 with attribution in some cases to the spike protein produced by the vaccines by itself rather than the virus. 6 - 9 , 11 - 15 …”

“…Mostly unexplored in the literature is the specific opportunity to develop COVID-19-like symptoms following vaccinations which create the SARS-CoV-2 spike protein, which starts to be covered consistently in the literature. 6 - 9 , 11 - 15 …”

Systematic review of cardiac adverse effects in children and young people under 18 years of age after SARS-CoV-2 vaccination

“…We considered data from case reports/case series separately from the data extracted from databases reporting adverse effects of vaccination against SARS-CoV-2. Data from three passive surveillance databases were used in included studies; the European Medicines Agency's European database of suspected adverse drug reaction reports (EudraVigilance, covering European Union and European Economic Area countries) 21 , the Centers for Disease Control (CDC) Vaccine Adverse Event Reporting System (VAERS, covering the USA), 20 and the World Health Organisation's global Individual Case Safety Report Database, VigiBase 23 . More than 130 countries contribute to VigiBase although more than 85% of adverse effects caused by BNT162b2 (Pfizer) vaccine were reported from countries in Europe and America 24 .…”

“…Three included studies used data extracted from passive vaccine surveillance systems, the EudraVigilance 44 , VAERS 20 44 and VigiBase 23 databases with most recent data being from 30 June 2021 (VigiBase 23 ), 6 August 2021 (EudraVigilance 44 ) and 18 August 2021 (VAERS 20 ).…”

“…The study from VigiBase reported 291 events after the Pfizer vaccine and 3 after the Moderna vaccine; 249 events were myocarditis and 45 were pericarditis, with no deaths amongst the 12-17 year age-group 23 . Compared with females, the odds of myocarditis was 12.0 (95% CI: 7.9-18.3) for males 12-17 years, with odds for pericarditis amongst boys compared with girls being 12.7 (95% CI: 4.5-35.5) 23 .…”