Evidence map›Paper›PMID 37012114›Full record

SynthesisVaccine2023

Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis.

Agustín Ciapponi, Mabel Berrueta, Edward P K Parker, Ariel Bardach, Agustina Mazzoni, Steven A Anderson, Fernando J Argento, Jamile Ballivian, Karin Bok, Daniel Comandé and 11 more

Open access · hybridFull text readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 4 pooled it
22.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 4 syntheses or guidelines pooled it, 77 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Neonatal and maternal outcomes of mRNA versus Non-mRNA COVID-19 vaccines in pregnant patients: a systematic review and meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2024
    Pooled it
  5. Trial
  6. Article
  7. Observational
  8. Observational
  9. Article
  10. Global vaccine development.Nature medicine · 2026
    Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 10 institutions in 6 countries.

Agustín CiapponiCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina. Electronic address: aciapponi@iecs.org.ar.
Mabel BerruetaCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina. Electronic address: mberrueta@iecs.org.ar.
Edward P K ParkerThe Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. Electronic address: Edward.Parker@lshtm.ac.uk.
Ariel BardachCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina. Electronic address: abardach@iecs.org.ar.
Agustina MazzoniCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina. Electronic address: amazzoni@iecs.org.ar.
Steven A AndersonUS Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: Steven.Anderson@fda.hhs.gov.
Fernando J ArgentoCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina. Electronic address: fargento@iecs.org.ar.
Jamile BallivianCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina.
Karin BokNational Institute of Allergy and Infectious Diseases, National Institutes of Health, 31 Center Dr # 7A03, Bethesda, MD 20892, USA. Electronic address: karin.bok@nih.gov.
Daniel ComandéCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina. Electronic address: dcomande@iecs.org.ar.
Erin GoucherSchool of Public Health and Tropical Medicine, Tulane University, New Orleans, USA. Electronic address: egoucher@tulane.edu.
Beate KampmannThe Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK; Vaccines & Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, the Gambia; Charité Centre for Global Health, Universitätsmedizin Charité Berlin, Germany. Electronic address: Beate.Kampmann@lshtm.ac.uk.
Flor M MunozThe Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. Electronic address: florm@bcm.edu.
Federico Rodriguez CairoliCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina. Electronic address: fcairoli@iecs.org.ar.
Victoria Santa MaríaCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina.
Andy S StergachisSchool of Pharmacy and School of Public Health, University of Washington, 1959 NE Pacific St, BOX 357631, Seattle, WA, USA. Electronic address: stergach@uw.edu.
Gerald VossCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway. Electronic address: gerald.voss@cepi.net.
Xu XiongNational Institute of Allergy and Infectious Diseases, National Institutes of Health, 31 Center Dr # 7A03, Bethesda, MD 20892, USA. Electronic address: xxiong@tulane.edu.
Natalia ZamoraCentro de Investigación de Epidemiología y Salud Pública (CIESP) - Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Argentina.
Sabra ZaraaBaylor College of Medicine, Texas Children's Hospital, 6621 Fannin St, Houston, TX 77030, USA. Electronic address: szaraa@uw.edu.
Pierre M BuekensNational Institute of Allergy and Infectious Diseases, National Institutes of Health, 31 Center Dr # 7A03, Bethesda, MD 20892, USA. Electronic address: pbuekens@tulane.edu.
Consejo Nacional de Investigaciones Científicas y Técnicas · ARLondon School of Hygiene & Tropical Medicine · GBNational Institutes of Health · USBaylor College of Medicine · USCoalition for Epidemic Preparedness Innovations · NONational Institute of Allergy and Infectious Diseases · USTulane University · USUnited States Food and Drug Administration · USUniversity of London · GBUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAssessment of COVID-19 vaccines safety during pregnancy is urgently needed.

methodsWe conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185).

resultsWe retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49-15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56-2.12). Animal studies showed consistent results with studies in pregnant persons.

conclusionWe found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.

Indexed as

COVID-19VaccinesAdjuvants, ImmunologicAluminumCOVID-19 VaccinesFemaleHumansPregnancyVaccinationAdjuvants, ImmunologicAluminumCOVID-19 VaccinesVaccinesAdjuvantCOVID-19Meta-analysisPregnancySystematic reviewVaccine safety

Identifiers

PMID37012114
PMCPMC10040368
OpenAlexW4361011616

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read132
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.