Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis
- PMID: 37012114
- PMCID: PMC10040368
- DOI: 10.1016/j.vaccine.2023.03.038
Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis
Abstract
Background: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed.
Methods: We 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).
Results: We 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.
Conclusion: We 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.
Keywords: Adjuvant; COVID-19; Meta-analysis; Pregnancy; Systematic review; Vaccine safety.
Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.
Conflict of interest statement
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Pierre M. Buekens reports financial support was provided by Bill & Melinda Gates Foundation].
Figures
Similar articles
-
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis.Drug Saf. 2024 Oct;47(10):991-1010. doi: 10.1007/s40264-024-01458-w. Epub 2024 Jul 15. Drug Saf. 2024. PMID: 39009928 Free PMC article.
-
Safety of COVID-19 vaccines, their components or their platforms for pregnant women: A rapid review.medRxiv [Preprint]. 2021 Jun 6:2021.06.03.21258283. doi: 10.1101/2021.06.03.21258283. medRxiv. 2021. Update in: Vaccine. 2021 Sep 24;39(40):5891-5908. doi: 10.1016/j.vaccine.2021.08.034. PMID: 34127978 Free PMC article. Updated. Preprint.
-
Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review.Vaccine. 2021 Sep 24;39(40):5891-5908. doi: 10.1016/j.vaccine.2021.08.034. Epub 2021 Aug 13. Vaccine. 2021. PMID: 34489131 Free PMC article. Review.
-
Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217. Cochrane Database Syst Rev. 2022. PMID: 36321557 Free PMC article.
-
Safety monitoring of bivalent mRNA COVID-19 vaccine among pregnant persons in the vaccine adverse event reporting System - United States, September 1, 2022 - March 31, 2023.Vaccine. 2024 Apr 2;42(9):2380-2384. doi: 10.1016/j.vaccine.2024.02.084. Epub 2024 Mar 11. Vaccine. 2024. PMID: 38462432 Review.
Cited by
-
Neonatal and maternal outcomes of mRNA versus Non-mRNA COVID-19 vaccines in pregnant patients: a systematic review and meta-analysis.Rev Bras Ginecol Obstet. 2024 Sep 18;46:e-rbgo69. doi: 10.61622/rbgo/2024rbgo69. eCollection 2024. Rev Bras Ginecol Obstet. 2024. PMID: 39380590 Free PMC article. Review.
-
T-cell responses to ancestral SARS-CoV-2 and Omicron variant among unvaccinated pregnant and postpartum women living with and without HIV in South Africa.Sci Rep. 2024 Sep 2;14(1):20348. doi: 10.1038/s41598-024-70725-8. Sci Rep. 2024. PMID: 39223211 Free PMC article.
-
COVID-19 and influenza vaccine uptake among pregnant women in national cohorts of England and Wales.NPJ Vaccines. 2024 Aug 14;9(1):147. doi: 10.1038/s41541-024-00934-9. NPJ Vaccines. 2024. PMID: 39143081 Free PMC article.
-
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis.Drug Saf. 2024 Oct;47(10):991-1010. doi: 10.1007/s40264-024-01458-w. Epub 2024 Jul 15. Drug Saf. 2024. PMID: 39009928 Free PMC article.
-
Pregnancy Outcomes among Pregnant Persons after COVID-19 Vaccination: Assessing Vaccine Safety in Retrospective Cohort Analysis of U.S. National COVID Cohort Collaborative (N3C).Vaccines (Basel). 2024 Mar 11;12(3):289. doi: 10.3390/vaccines12030289. Vaccines (Basel). 2024. PMID: 38543923 Free PMC article.
References
-
- Figueiro-Filho E.A., Yudin M., Farine D. COVID-19 during pregnancy: an overview of maternal characteristics, clinical symptoms, maternal and neonatal outcomes of 10,996 cases described in 15 countries. J Perinat Med. 2020;48:900–911. - PubMed
-
- Zambrano L.D., Ellington S., Strid P., Galang R.R., Oduyebo T., Tong V.T., et al. Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-October 3, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1641–1647. - PMC - PubMed
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Medical