Study registration: *
Publication Dagan N, N Engl J Med, 2021
Dates: 20/12/2020 to 01/02/2021
Funding: Public/non profit (Morrisâ Singer Fund)
Conflict of interest: Yes (Dr. Barda, Dr. Dagan, and Dr. Balicer report grants from Pfizer, outside the submitted work.)

Methods

Study design:Cohort
Description of participants: Individuals 16 years and older with no previous documented infection with SARS-CoV-2 (PCR) in Israel
Inclusion criteria:
  • Age of 16 years or older
  • Not having a previously documented positive SARS-CoV-2 polymerase-chain-reaction (PCR) test
  • Being a member of the health care organization during the previous 12 months.

Exclusion criteria:
  • Persons not having a documented geostatistical living area
  • Those who have had interactions with the health care system during the preceding 3 days that may indicate the start of symptomatic disease and may preclude vaccination
  • Nursing home residents
  • Persons medically confined to the home
  • Health care workers

Follow-up duration (months): 1.44
Vaccines:
  • 2 IM doses of BNT162b2, 21 days apart
Variant description :
Variant name: Alpha
Evidence: Indirect evidence (prevalence of variant in the population: 10 to 70%)
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: No, NR
Data accessibility: NR
General comment Concerns over uncontrolled confounding; informative censoring (control participants who went on to get vaccinated are likely to be different from those who did not); and (for data on infections) the likelihood of getting tested for infection may depend on vaccination status.