Study registration: NCT04848584
Publication Tartof S, Lancet, 2021
Dates: 2020-12-14 to 2021-08-08
Funding: Private (Pfizer Inc.)
Conflict of interest: Yes (MZ, SG, KP, FJA, LJ, SRV, and JMM are employees of and hold stock and stock options in Pfizer. TBF holds shares of Pfizer stock. SYT, JMS, HF, VH, BKA, ONR, TBF, and OAO received research support from Pfizer during the conduct of this study that was paid directly to KPSC. For work unrelated to this project, SYT received research funding from Gilead, GlaxoSmithKline, and Genentech; BKA received research funding from GlaxoSmithKline, Novavax, Dynavax, Genentech, Novartis, Seqirus, and Moderna; JMS received research funding from Novavax, Dynavax, and ALK; and HF received research funding from Genentech. All other authors declare no competing interests.)

Methods

Study design:Cohort
Description of participants: Kaiser Permanente Southern California healthcare system members aged 12 and up in multiple centres in USA
Inclusion criteria:
  • All Kaiser Permanente Southern California members ≥12 years of age
  • ≥1 year of prior membership

Exclusion criteria:
  • Patients with documentation requesting removal from all research studies

Follow-up duration (months): 7.90
Vaccines:
  • 2 doses of BNT162b2
Variant description :
Variant name: Delta
Evidence: Direct evidence (effectiveness determined by sequencing cases)
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes
Data accessibility: Individual-level testing and clinical outcomes data reported in this study are not publicly shared. Individuals wishing to access disaggregated data, including data reported in this study, should submit requests for access to SYT (sara.y.tartof@kp.org). Deidentified data (including, as applicable, participant data and relevant data dictionaries) will be shared upon approval of analysis proposals with signed data-access agreements in place.
General comment In addition to the preprint, the study registry record was used in data extraction and risk of bias assessment.