Covid-19 Living Data

Study registration: *
Publication Bruxvoort K, SSRN, 2021
Dates: 2020-12-18 to 2021-06-30
Funding: Private (Moderna Inc.)
Conflict of interest: Yes (KJB, LSS, LQ, BKA, YL, GSL, YT, AF, HST, JET, HFT are employees of Kaiser Permanente Southern California, which has been contracted by Moderna for the conduct of this present study. CAT is an employee of and a shareholder in Moderna Inc. KJB received funding from GlaxoSmithKline, Dynavax, Pfizer, Gilead, and Seqirus unrelated to this manuscript. LSS received funding from GlaxoSmithKline, Dynavax, and Seqirus unrelated to this manuscript. LQ received funding from GlaxoSmithKline and Dynavax unrelated to this manuscript. BKA received funding from GlaxoSmithKline, Dynavax, Seqirus and Pfizer unrelated to this manuscript. YL received funding from GlaxoSmithKline, Dynavax, Seqirus and Pfizer unrelated to this manuscript. GSL received funding from GlaxoSmithKline unrelated to this manuscript. YT received funding from GlaxoSmithKline unrelated to this manuscript. AF received funding from Pfizer, GlaxoSmithKline, CDC, and Gilead unrelated to this manuscript. HST received funding from GlaxoSmithKline, Pfizer, ALK, and Wellcome unrelated to this manuscript. JET received funding from Pfizer unrelated to this manuscript. HFT received funding from GlaxoSmithKline and Seqirus unrelated to this manuscript; HFT also served in advisory boards for Janssen and Pfizer.)

Methods
Methods	Study design:Cohort Description of participants: Adults aged ≥18 years who are members of Kaiser Permanente Southern California in the USA Inclusion criteria: Aged ≥18 years members of Kaiser Permanente Southern California for ≥12 months prior to receipt of the second dose of mRNA-1273 (for vaccinated individuals and their matched unvaccinated counterparts) vaccinated group - 2 doses of mRNA-1273 at least 24 days apart (4-day grace period allowed prior to the recommended 28-day interval) from December 18, 2020 to March 31, 2021 unvaccinated comparison group - eligible individuals who had not received mRNA-1273 or any other COVID-19 vaccine as of the index date, randomly selected and 1:1 matched to vaccinated individuals by age (18–44 years, 45–64 years, 65–74 years, and ≥75 years), sex, and race/ethnicity (Non-Hispanic White, Non-Hispanic Black, Hispanic, Non-Hispanic Asian, and Other/Unknown). Exclusion criteria: Received a COVID-19 vaccine other than mRNA-1273 prior to the index date (2nd dose of mRNA-1273 ) received 2 doses of mRNA-1273 <24 days apart received any COVID-19 vaccine <14 days after the index date had no health care utilization and no vaccination from the 2 years prior to the index date through the index date had a COVID-19 outcome <14 days after the index date. Follow-up duration (months): 6.47
Vaccines:	2 doses of mRNA-1273
Variant description :
Variant description :	Variant name: Delta Evidence: Indirect evidence (prevalence of variant in the population: 5.0 - 47.1)
Documents available	Protocol NR Statistical plan NR Data-sharing stated: Yes Data accessibility: Katia Bruxvoort, PhD, MPH Email: kbruxvoort@uab.edu
General comment	Concerns regarding the lack of adjustment for covid symptoms at the time of potential vaccination - a potentially important confounder.