Post-marketing safety of the Moderna COVID-19 vaccine following the 2024/2025 strain change in the United States

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  No individual level data collected for the purpose of the study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SPIKEVAX
• Medicinal product name, other:
  mRNA-1273.712
• 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

Study design details

• Study design:
  ​​This retrospective US cohort study will actively monitor safety outcomes following administration of mRNA-1273.712 targeting the SARS-CoV-2 KP.2 variant among individuals in the US enrolled in commercial and Medicare Advantage plans.
• Data analysis plan:
  Analyses will be conducted within each database, and results will be pooled through a meta-analysis when appropriate. ; Analyses for <65 years old and ≥65 years old population will be conducted separately, given differences in the insurance coverage. ; Covariates will be described via summary statistics and for continuous variables will include mean, standard deviation, median, interquartile range; for categorical variables, counts and proportions.