Effectiveness and safety of COVID-19 vaccine in pregnant women: A systematic review with meta-analysis

Mara Tormen; Cristina Taliento; Stefano Salvioli; Irene Piccolotti; Gennaro Scutiero; Rosaria Cappadona; Pantaleo Greco

doi:10.1111/1471-0528.17354

Effectiveness and safety of COVID-19 vaccine in pregnant women: A systematic review with meta-analysis

BJOG. 2023 Mar;130(4):348-357. doi: 10.1111/1471-0528.17354. Epub 2022 Dec 12.

Authors

Mara Tormen^{1

2}, Cristina Taliento², Stefano Salvioli^{3

4}, Irene Piccolotti², Gennaro Scutiero^{1

2}, Rosaria Cappadona², Pantaleo Greco^{1

2}

Affiliations

¹ Maternal and Child Department, Unit of Obstetrics and Gynecology, S. Anna University Hospital, Cona, Ferrara, Italy.
² Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
³ Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Sciences (DINOGMI), University of Genoa - Campus of Savona, Savona, Italy.
⁴ Department of Neuroscience and Rehabilitation, University of Ferrara, Ferrara, Italy.

Abstract

Background: There are limited data regarding COVID-19 vaccination during pregnancy.

Objectives: To evaluate the effects of COVID-19 vaccination received during pregnancy on SARS-CoV-2 infection, COVID-19-related hospitalisation, COVID-19-related intensive care unit (ICU) admission and maternal-fetal complications.

Search strategy: MEDLINE, CINHAL, Embase, Scopus and CENTRAL databases, as well as ClinicalTrials.gov, reference lists, related articles and grey literature sources.

Selection criteria: Randomised controlled trials, non-randomised studies of interventions, pregnant women, COVID-19 vaccination during pregnancy.

Data collection and analysis: Study selection, risk-of-bias assessment, data extraction and assessment of the certainty of evidence using the GRADE method were performed independently by two authors. Meta-analyses were performed using Cochrane RevMan 5.4. PROSPERO registration number: CRD42022308849.

Main results: We included 14 observational studies (362 353 women). The administration of a COVID-19 vaccine during pregnancy resulted in a statistically significant reduction in SARS-CoV-2 infection (OR 0.46, 95% CI 0.28-0.76) and COVID-19-related hospitalisation (OR 0.41, 95% CI 0.33-0.51). The effect appeared to be greater in fully vaccinated women, for both infection (OR 0.31, 95% CI 0.16-0.59) and hospitalisation (OR 0.15, 95% CI 0.10-0.21). However, the certainty of evidence was very low. The difference in COVID-19-related ICU admission between vaccinated and unvaccinated individuals did not reach statistical significance (OR 0.58, 95% CI 0.13-2.58). Finally, there were no statistically significant differences in any of the maternal-fetal complications considered in the included studies.

Conclusions: COVID-19 vaccination administered during pregnancy seems to reduce SARS-CoV-2 infection and COVID-19-related hospitalisation, with no significant effects on maternal-fetal complications.

Keywords: COVID-19 vaccine; SARS-CoV-2; effectiveness; meta-analysis; pregnancy; systematic review.

Publication types

Meta-Analysis
Systematic Review
Review

MeSH terms

COVID-19 Vaccines* / adverse effects
COVID-19* / epidemiology
COVID-19* / prevention & control
Female
Humans
Intensive Care Units
Pregnancy
Pregnant Women*
SARS-CoV-2

Substances

COVID-19 Vaccines