mRNA-1273-P911: Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  SPIKEVAX
• Name of medicine, other:
  Spikevax bivalent

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  The main goal of this study is to characterize presentation, clinical course, and long-term outcomes of myocarditis temporally associated with administration of mRNA-1273 (SPIKEVAX) COVID-19 vaccine.
• Outcomes:
  Outcomes will include major adverse clinical outcomes, structural or functional cardiac abnormalities, and patient-reported outcomes and functional assessments. Required medication or related cardiac procedures during and following hospitalization, along with cardiac or other hospitalization events, and presence and findings from ambulatory monitoring will be described across the follow-up period. Risk factors for adverse long-term outcomes of vaccine-associated myocarditis including demographic factors, lifestyle factors, and medical history.
• Data analysis plan:
  Patients with myocarditis will be described in terms of demographic characteristics, lifestyle factors, and medical history, stratified by and compared across study cohorts. The clinical course of the index myocarditis event will be described for myocarditis cases by exposure status, including analysis of relevant procedures, available data on outcomes, relevant healthcare utilization, and occurrence of additional cardiac events over the follow-up period. Regression models assessing the relative risk of long-term adverse outcomes among vaccine-associated myocarditis (VAM) compared cases relative to non-vaccine myocarditis (NVM) cases. A predictive modeling approach will be used to identify potential risk factors associated with long-term outcomes, if identified, among vaccine-associated myocarditis cases.