This is an observational cohort study to evaluate real-world vaccine effectiveness anddurability of Moderna COVID-19 vaccine among a diverse population at Kaiser PermanenteSouthern California (KPSC).The primary objective of this study is to evaluate the vaccine effectiveness (VE) ofreceipt of Moderna COVID-19 vaccine in preventing SARS-CoV-2 infection and severeCOVID-19 disease.SARS-CoV-2 infection will be defined as a positive antigen test result as well as apositive molecular diagnostic test among symptomatic or asymptomatic participants or aCOVID-19 diagnosis code. Severe COVID-19 disease will be defined as COVID-19hospitalization or mortality.
This study utilized electronic healthcare data collected within the Kaiser Permanente
Southern California (KPSC) integrated healthcare system which provides care to over 4.6
million individuals. Participants in this study received vaccination and were assessed
for study outcomes as part of routine care. Vaccination information and study outcome
status was assessed using procedure, diagnostic, and laboratory code information. Medical
chart review was conducted to assess the association of severe outcomes (hospitalization
and death) with COVID-19 illness.
Analyses assessing absolute vaccine effectiveness will identify participants who receive
Moderna COVID vaccine from the KPSC electronic healthcare database and match them to
unvaccinated participants based on age, sex, race/ethnicity, and data of vaccination
(index date). Vaccinated and unvaccinated participants will then be followed-up in the
database for the occurrence of study outcomes. Cox proportional hazards regression will
be used to compare the relative risk of study outcomes by vaccination status.
Analyses of relative vaccine effectiveness will identify participants who receive
specific dose number and formulation of Moderna COVID vaccine (Group N) from the KPSC
electronic healthcare database and match them to a group of vaccinated participants with
a different dose/formulation type (i.e. Group n-1). Similar matching criteria will be
applied. Both groups will be followed for study outcomes and cox proportional hazards
regression will be used to compare the relative risk of study outcomes by vaccination
status.
Inclusion Criteria:
- Aged ≥18 years at index date (participants aged 6 months through 17 years will also
be included after Food and Drug Administration [FDA] authorization to vaccinate
younger age groups)
- KPSC member for ≥12 months prior to index date through 14 days after the index date
(allowing a 31-day gap)
Exclusion Criteria:
- Receipt of a COVID-19 vaccine other than Moderna COVID-19 vaccine prior to or on the
index date
- Receipt of 2 doses of Moderna COVID-19 vaccine <24 days apart for 2-dose exposed
cohort
- Receipt of any COVID-19 vaccine <14 days after the index date
- No health care utilization and no vaccination from the 2 years prior to the index
date through the index date
- Occurrence of a COVID-19 outcome <14 days after the index date
Kaiser Permanente Southern California
Pasadena, California, United States
Not Provided