Cohort 1: Influenza vaccinated concurrent comparator Eligible vaccine episodes must meet the following inclusion criteria within the protocol-specified time windows: - Non-missing sex: (start of available data, 1 day prior to index) - No receipt of elasomeran/davesomeran and andusomeran vaccine: (90 days prior to index, 1 day prior to index) - No receipt of influenza vaccine: (90 days prior to index, 1 day prior to index) - No receipt of any other COVID-19 vaccine: (90 days prior to index, index date) - Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date) Cohort 2: Medically attended COVID-19 concurrent comparator Eligible vaccine and disease episodes must meet the following inclusion criteria within the specified time windows: - Non-missing sex: (start of available data, 1 day prior to index) - No receipt of elasomeran/davesomeran and andusomeran vaccine: (180 days prior to index, 1 day prior to index) - No evidence of medically attended COVID-19: (180 days prior to index, 1 day prior to index) - No receipt of any other COVID-19 vaccine: (180 days prior to index, index date) - Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)

• Vaccine and disease episodes with a prior AESI within the washout window will be excluded from the analytic cohort. - For the influenza vaccinated concurrent comparator cohort, individuals who receive an elasomeran/davesomeran and andusomeran vaccine and an influenza vaccine on the same day or within a minimum number of days will be excluded from the primary analysis. Note: Other protocol-defined inclusion/exclusion criteria may apply.