Study registration: *
Publication Bruxvoort K, medRxiv, 2021
Dates: 2021-03-01 to 2021-07-27
Funding: Private (Moderna Inc.)
Conflict of interest: Yes (KJB, LSS, LQ, BKA, YL, GSL, YT, AF, MA, JET, HST, JHK, and HFT are employees of Kaiser Permanente Southern California, which has been contracted by Moderna for the conduct of this present study. KJB received funding from GlaxoSmithKline, Dynavax, Pfizer, Gilead, and Seqirus 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

Study design:Test-negative
Description of participants: Adults members of an integrated health care system (KPSC) in the USA
Inclusion criteria:
  • Individuals who had a SARS-CoV-2 positive test sent for WGS or a negative test from March 1, 2021 to July 27, 2021
  • Age ≥18 years
  • ≥12 months of KPSC membership as of the specimen collection date.

Exclusion criteria:
  • Received a COVID-19 vaccine other than mRNA-1273
  • Received 2 doses of mRNA-1273 <24 days apart or <14 days prior to specimen collection date
  • Received >2 doses of mRNA-1273 prior to the specimen collection date
  • Positive SARS-CoV-2 test or COVID- 19 diagnosis code between 12/18/2020 and 2/28/2021 or ≤90 days prior to positive test date.

Follow-up duration (months): 4.89
Vaccines:
  • 1 or 2 doses of mRNA-1273
Variant description :
Variant name: Delta
Evidence: Direct evidence (effectiveness determined by sequencing cases)
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated: Yes
Data accessibility: Upon request, and subject to review, KPSC may provide the deidentified aggregate-level data that support the findings of this study. Deidentified data (including participant data as applicable) may be shared upon approval of an analysis proposal and a signed data access agreement.
General comment Potential for residual confounding, selection bias (e.g. due to the test-negative design), concerns around potential differential testing (for infection outcomes only), and lack of a pre-determined analysis plan.