Inclusion Criteria:

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)

Exclusion Criteria:

- 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.