mRNA-1273-P920, Post-marketing safety of elasomeran/davesomeran and andusomeran vaccines in the United States

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, Spikevax XBB.1.5
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN01) covid-19, RNA-based vaccine

  covid-19, RNA-based vaccine

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  10000000

Study design details

• Main study objective:
  The overarching aim of this study is to characterize the safety of the Omicron-containing bivalent SARS-CoV-2 mRNA-1273 booster vaccine as used in routine clinical practice.
• Outcomes:
  Number of Participants With Adverse Events of Special Interest (AESI)
• Data analysis plan:
  Primary Cohort Analysis For each patient, a propensity score (PS) will be calculated to estimate the probability of receiving a dose of the elasomeran/davesomeran or andusomeran vaccine conditional on measured covariates. ; The PS will be calculated utilizing inverse probability of treatment weighting (IPTW).