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Table 1 Summary of the included studies

From: Maternal and neonatal safety outcomes after SAR-CoV-2 vaccination during pregnancy: a systematic review and meta-analysis

Study ID

Study design, country and time of realization

Participants

Intervention group

Control group

Main inclusion criteria

Exclusion criteria

Primary outcomes

Beharier 2021 [20]

Cohort, Jerusalem, between April 2020 and March 2021

1094

Vaccinated group during pregnancy

Unvaccinated non infected controls

Age of 18 years or older and a willingness to participate and provide informed consent

Pregnant women with active maternal COVID-19 disease at delivery

Blakeway 2021 [30]

Cohort, London, United Kingdom, between March 1, 2020, and July 4, 2021

1328

At least 1 dose during pregnancy

Did not receive a vaccine during pregnancy

Pregnant women with known vaccination status and complete maternal and fetal outcome data

women who were vaccinated entirely (i.e., all doses) before pregnancy or after birth or women who had pregnancies complicated by fetal aneuploidy or genetic syndromes

COVID-19 vaccine uptake during pregnancy among women eligible for vaccination

Butt 2021 [31]

Case–control, Qatar, Between December 20, 2020, and May 30, 2021

2020

PCR positive of Pregnant women

PCR negative of Pregnant women

All women presented to Hamad Medical Corporation between December 20, 2020, and May 30, 2021, with confirmed pregnancies

who were tested for SARS-CoV-2 by RT-PCR prior to pregnancy and those who had no SARS-CoV-2 testing done between December 20, 2020, and May 30, 2021

overall vaccine effectiveness > 14 days after the second dose of the vaccine, we also determined vaccine effectiveness > 14 days after the first dose up to the date of the second dose

Collier 2021 [32]

Cohort, Jerusalem, from December 2020 through March 2021

103

Pregnant Vaccinated women

Pregnant Unvaccinated and infected women

Pregnant, lactating, and non-pregnant women aged 18 to 45 years who were vaccinated or infected

_

SARS-CoV-2 receptor binding domain binding, neutralizing, and functional non-neutralizing antibody responses from pregnant, lactating, and nonpregnant women were assessed following vaccination

Dagan 2021 [33]

Cohort Jerusalem, between 20 December 2020 and 3 June 2021

21,722

Pregnant Vaccinated women

Pregnant Unvaccinated and infected women

Pregnancy, age of 16 years or older, continuous membership in CHS for 1 complete year, no previous positive SARS-CoV-2 PCR test, no previous SARS-CoV-2 vaccination, not residing in long-term care facilities

Individuals with missing data (only relevant for the body mass index and living area variables)

documented SARS-CoV-2 infection, symptomatic SARS-CoV-2 infection (COVID-19), COVID-19-related hospitalization; severe COVID-19, and COVID-19-related death

Kharbanda 2021 [35]

Cohort, USA, from December 15, 2020, through June 28, 2021

21,267

Ongoing pregnancy periods (vaccinated women)

Spontaneous abortions (vaccinated women)

_

_

_

Rottenstreich 2021 [36]

Cohort, Jerusalem, between January and April 2021

1775

Covid‐19 vaccinated Pregnant women

Covid‐19 Unvaccinated Pregnant women

All women aged 18 years or older, with no documented previous positive PCR test, who delivered between 19 January 2021 (when the first vaccinated women gave birth) and 27 April 2021

women with current or previous Covid‐19 disease

chorioamnionitis, postpartum hemorrhage, endometritis, blood transfusion, a cesarean delivery (CD), ICU admission, and a maternal hospital length of stay of > 5 days for vaginal delivery and > 7 days for CD

Shanes 2021 [37]

Cohort, USA

200

Pregnant Vaccinated women

Pregnant Unvaccinated women

_

_

_

Theiler 2021 [38]

Cohort, USA

2002

Covid‐19 vaccinated Pregnant women

Covid‐19 Unvaccinated Pregnant women

All patients aged 16 to 55 years with a delivery event between December 10, 2020, and April 19, 2021, at a hospital within the Mayo Clinic Health System

Patients who opted out to use their medical records for research if their delivery occurred in Minnesota

(1) maternal death during hospitalization; (2) intrapartum neonatal death within 7 days of birth; (3) hypoxic-ischemic encephalopathy; (4) uterine rupture; (5) unplanned maternal ICU admission; (6) return to the operating room within 72 h of delivery; (7) postpartum hemorrhage with blood transfusion; (8) third- or fourth-degree laceration; (9) 5-min Apgar score of < 7; (10) admission to the neonatal ICU within 1 day of birth for > 1 day; or (11) neonatal birth trauma

Wainstock 2021 [39]

Cohort, Jerusalem, between January and June 2021

4,860

Covid‐19 vaccinated Pregnant women

Covid‐19 Unvaccinated Pregnant women

_

_

_

Pfizer BioNTech C4591001

RCT

37,706

BNT162b2 (30 μg)

Placebo

_

_

vaccine efficacy

Moderna mRNA-1273-P301

RCT

30,418

Moderna COVID-19 Vaccine mRNA-1273

Placebo

_

_

_

COV003 (Brazil)

RCT, Brazil

6753

ChAdOx1 nCoV-19

MenACWY "control vaccine" (first dose), Saline (second dose)

Adults aged 18 years and older

_

_