Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  200000015711

  covid-19 vaccines
• Medical condition to be studied:
  Myocarditis
• Additional medical condition(s):
  Pericarditis

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  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:
  1

Study design details

• Main study objective:
  To describe the clinical course (treatment, survival, hospitalisations, long-term cardiac outcomes) of myocarditis or pericarditis among individuals diagnosed with myocarditis and/or pericarditis after receiving at least 1 dose of the Pfizer-BioNTech COVID-19 vaccine and among individuals diagnosed
• Outcomes:
  Potential outcomes for myocarditis are treatment, recovery, survival, hospitalisations, sudden cardiac death, heart failure, cardiogenic shock, fulminant myocarditis, inflammatory cardiomyopathy, heart transplant, and arrhythmia. Potential outcomes for pericarditis are treatment, recovery, survival, hospitalisations, and chronic, restrictive, and recurrent pericarditis. Potential risk factors for myocarditis and pericarditis, such as age, sex, Pfizer-BioNTech COVID-19 vaccination status, vaccine doses received (e.g. first, second, third, and booster doses), and history of COVID-19
• Data analysis plan:
  For the primary objective, the distributions of vaccination status and other baseline characteristics will be described. For continuous variables, means, standard deviations and quartiles will be estimated. For categorical variables, counts and proportions will be estimated. The missingness of variables will also be described. The occurrence of the different treatments and outcomes during follow-up will be described using counts and proportions. Continuous variables (e.g. length of stay) will be described using means, standard deviations and quartiles. When appropriate, the occurrence of time-to-event outcomes (e.g. death) will be described using the Kaplan-Meier estimator or curve. Analysis will be performed overall by sex and age, COVID-19 history, vaccination status, and time since vaccination.