Study registration: *
Publication Goldshtein I, JAMA, 2021
Dates: 2020-12-19 to 2021-02-28
Funding: Not reported/unclear
Conflict of interest: no COI (None reported)

Methods

Study design:Cohort
Description of participants: Pregnant women with no history of SARS-CoV-2 registered in a a large state-mandated health care organization in Israel
Inclusion criteria:
  • All female members of a large state-mandated health care organization (Maccabi Healthcare Services) who were pregnant at any time from December 19, 2020 (initiation of the national vaccination campaign), through February 28, 2021

Exclusion criteria:
  • Members who joined the fund less than 1 year preconception
  • preconception records indicating SARSCoV-2 infection (defined as a positive polymerase chain reaction test result or a hospital diagnosis of SARS-CoV-2 infection)
  • vaccinated prepregnancy with the BNT162b2 mRNA vaccine

Follow-up duration (months): 2.33
Vaccines:
  • 1 or 2 doses of BNT162b2
Variant description :
Variant name: Alpha
Evidence: Indirect evidence (prevalence of variant in the population: >50%)
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated: NR
Data accessibility: Corresponding Author: Inbal Goldshtein, PhD, Maccabi Healthcare Services, 4 Yehezkel Kaufmann St, Tel Aviv, Israel 68125 (goldst_in@mac.org.il)
General comment Moderate concerns over possible residual confounding, informative censoring leading to potentially missing outcome data, and no access to a protocol or statistical analysis plan.