Regulatory authorities nationally and internationally have concluded that myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the pericardium) are rare side effects after vaccination with Covid-19 mRNA vaccines. Since myocarditis and pericarditis are serious side effects where there is no good data on triggers or cardiac effects in the long term, there is an urgent need to both validate the reported disease cases and their course in Norway and to follow up the patients afterwards.
This project is a collaboration between the National Institute of Public Health (NIPH), The Norwegian Medicines Agency (SLV) and Oslo University Hospital (OUS) where the purpose is:
1. to validate the cases of reported pericarditis and myocarditis after coronary vaccination in Norway, as well as identify risk factors (Validation study)
2. to investigate whether there are long-term cardiac effects after undergoing Covid-19 vaccine-triggered myocarditis (Clinical follow-up study).
In the validation study, we will include all patients reported to Norwegian health registries with possible vaccine-triggered myocarditis and pericarditis. We will find the patients by linking diagnostic codes from NPR with vaccine data from SYSVAK and information on infection from MSIS. By searching the patient records of the identified patients, we will confirm or deny the diagnosis Covid-19 vaccine-triggered myocarditis or pericarditis defined according to the Brighton criteria, as well as register the course and examine for possible risk factors. Patients with confirmed Covid-19 vaccine-triggered myocarditis diagnosis from the validation study will be invited to participate in the clinical follow-up study. Via search in patient records, we will collect retrospective data on the course of the disease during the acute myocarditis as well as general data such as other diseases, exercise habits, medication use, etc. Included patients will be admitted for control 1 and 2 years after the myocarditis for ECG cardiac exams, 24-hour rhythm recording, echocardiography / ultrasound of the heart, MRI of the heart and blood samples that will be stored in a study-specific biobank with the possibility of later analyzes. We collect endpoints, such as signs of heart disease or cardiac events after 1 and 2 years.
Covid-19 vaccine-triggered myocarditis and pericarditis are considered the most serious unexpected side effects of the Covid-19 vaccines. First and foremost, the study will provide good follow-up and possible treatment of affected patients. In addition, the study has a very great societal benefit by providing important information to the Coronary Vaccination Program on the long-term effects of vaccine adverse reactions. Validation is important quality assurance. Complete datasets without inclusion bias important to provide the real picture of the side effects. A precise knowledge base is important to avoid unnecessary concern among the population. We therefore request a dispensation from the duty of confidentiality for the validation study.
Both the incidence and severity of Covid-19 vaccine-triggered myocarditis and pericarditis will be crucial in defending mass vaccination of the population in the future.