The main goal of this study is to describe the clinical course, outcomes and risk factorsfor myocarditis and pericarditis associated with Moderna vaccination targetingSARS-CoV-2.
This study will use an "Moderna vaccination targeting SARS-CoV-2 - exposed case cohort
design" to assess the risk factors other than Moderna vaccination targeting SARS-CoV-2
vaccination for the development of myocarditis and pericarditis in Moderna vaccination
targeting SARS-CoV-2 recipients, to understand which characteristics increase or decrease
the risk for the development of myocarditis and pericarditis after Moderna vaccination
targeting SARS-CoV-2 vaccination.
The second design "a myocarditis/pericarditis cohort study design" will be used to
describe the prognostic factors for a severe clinical course in participants with
myocarditis or pericarditis regardless of vaccination status. As most myocarditis and
pericarditis cases are mild in disease severity, it is clinically relevant to identify
the participants who are at increased risk for severe clinical outcomes (such as acute
coronary syndrome, acute myocardial infarction, heart failure, atrial
fibrillation/flutter, ventricular arrhythmias/cardiac arrest, pulmonary embolism or deep
venous thrombosis, stroke outcomes, peripheral arterial embolism, hospital readmission,
intensive care unit [ICU] admission or death) as early as possible in order to provide
appropriate care in a timely manner. Therefore, information available at the onset of
myocarditis or pericarditis could be used to predict the clinical course including
long-term outcomes.
Biological: mRNA-1273
intramuscular injection
Other Name: Elasomeran,Imelasomeran,Davesomeran,Spikevax,Spikevax bivalent
Inclusion Criteria:
- For the Elasomeran-Moderna vaccination targeting SARS-CoV-2-exposed case-cohort
study, a cohort will be defined including participants of all ages with (1) at least
one dose of Moderna vaccination targeting SARS-CoV-2 administered during the study
period, (2) at least one year of enrolment in the applicable database prior to the
index vaccine dose to allow for ascertainment of baseline covariables and potential
risk factors, and (3) no myocarditis or pericarditis events within 6 months prior to
Moderna vaccination targeting SARS-CoV-2 receipt. Myocarditis and pericarditis cases
are defined when adjudication criteria similar to Centers for Disease Control and
Prevention (CDC) case definition for probable or definite myocarditis or
pericarditis is fulfilled.
- For the cohort study, participants will be included if they: (1) meet the
adjudication criteria similar to the CDC case definition for probable or definite
myocarditis or pericarditis, (2) have at least one year of enrolment in the
applicable database prior to the index myocarditis or pericarditis event to allow
for ascertainment of baseline covariates and potential risk factors, and (3) have
not received a COVID-19 vaccine other than Moderna vaccination targeting SARS-CoV-2
within 30 days prior to the index myocarditis or pericarditis event.
Exclusion Criteria:
- Participants who have evidence of myocarditis or pericarditis in structured data
(for example: ICD-10 codes) where review of clinical data is incompatible with
adjudication criteria similar to CDC case definition for myocarditis or pericarditis
will be described but will not be included as cases in primary analyses.
- In the Moderna vaccination targeting SARS-CoV-2-exposed case-cohort design, these
non-confirmed myocarditis/pericarditis cases will be censored at the onset of the
false positive myocarditis/ pericarditis diagnosis.
Aarhus University Hospital
Aarhus, Denmark
University of Oslo
Oslo, Norway
IDIAP Jordi Gol
Barcelona, Spain
FISABIO
Valencia, Spain
Drug Safety Research Unit (DSRU)
Southampton, United Kingdom
Not Provided