Background: Rise in incidences of carditis post Covid-19 vaccines and need of effective risk mitigation strategies (RMS).
Objectives: Statistical analysis of carditis from FAERS database and substantiates risk mitigation strategies.
Methods: To analyse association between carditis (Myocarditis/endocarditis/pericariditis) and Covid-19 vaccines FAERS database was searched from Jan 2021 to Aug 2022.
Results: Currently no RMS are available targeting carditis across the globe. As per our study 4884 patients’ data were screened, having at least 01 AE post Covid-19 vaccination. Among the population, total 144(2.94%) patients were affected with carditis. Pericarditis was common (n=81, 56.25%) followed by myocarditis (n=60, 41.66%), pleuropericarditis (n=4, 2.77%) and endocarditis (n=3, 2.08%). Among the (n=144) patients of carditis, 7 (4.86%), 55(38.19%) and 18(12.5%) cases of pericarditis were reported after receiving the vaccine of Astrazeneca, Pfizer-BioNTech and Moderna respectively. Myocarditis was reported in 30 cases (20.83%) of Pfizer-BioNTech vaccine, 3 (2.08%) with Astrazeneca and 27 (18.75%) cases with Moderna. Pleuropericarditis was observed with Moderna vaccine in 04 patients. With two proportional Z test, p value was (p < 0.05 with CI-95%) which further strengthens the possibilities of carditis in covid-19 vaccinated patients. As per this statistical analysis its important to have Pre-administration (A. Targeted questionnaire on how many dose received, any relevant cardiac history, any predisposing drug/s being taken by patient, any surgery including cardiac done recently etc. B. Lab parameters like Troponin-I&T, CPK-MB, etc) and post-administration risk minimization measures (A. Pictograms should be provided to consumers giving information on carditis related symptoms like, chest pain, sweating, fainting, , etc, which will help to identify symptoms by consumers easily and very early stage and reach out to HCPs at earliest, B. What are the primary care can be taken by consumer if carditis related sign/symptoms are there, C. Educational materials on Do and Don’ts for pre-administration post administration of vaccines) to prevent such events.
Conclusions: Our study results urges MAHs to develop suggested RMS in a digitally interconnected way with authorities, MAHs and patients have relevant information on very early stage to prevent the risk of carditis and to increase risk-benefit balance.
