Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis

PregCOV-19 Living Systematic Review Consortium, Silvia Fernández-García, Laura del Campo-Albendea, Dharshini Sambamoorthi, Jameela Sheikh, Karen Lau, Nana Osei-Lah, Anoushka Ramkumar, Harshitha Naidu, Nicole Stoney, Paul Sundaram, Paulomi Sengupta, Samay Mehta, Shruti Attarde, Sophie Maddock, Millie Manning, Zainita Meherally, Kehkashan Ansari, Heidi Lawson, Magnus YapTania Kew, Andriya Punnoose, Chloe Knight, Eyna Sadeqa, Jiya Cherian, Sangamithra Ravi, Wentin Chen, Kate Walker, Keelin O’Donoghue, Madelon van Wely, Elizabeth van Leeuwen, Elena Kostova, Heinke Kunst, Asma Khalil, Vanessa Brizuela, Edna Kara, Caron Rahn Kim, Anna Thorson, Olufemi T. Oladapo, Lynne Mofenson, Sami L Gottlieb, Mercedes Bonet, Ngawai Moss, Javier Zamora, John Allotey, Shakila Thangaratinam*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

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Abstract

Objective: To assess the effects of COVID-19 vaccines in women before or during pregnancy on SARS-CoV-2 infection-related, pregnancy, offspring and reactogenicity outcomes.

Design: Systematic review and meta-analysis.

Data sources: Major databases between December 2019 and January 2023.

Study selection: Nine pairs of reviewers contributed to study selection. We included test-negative designs, comparative cohorts and randomised trials on effects of COVID-19 vaccines on infection-related and pregnancy outcomes. Non-comparative cohort studies reporting reactogenicity outcomes were also included.

Quality assessment, data extraction and analysis: Two reviewers independently assessed study quality and extracted data. We undertook random-effects meta-analysis and reported findings as HRs, risk ratios (RRs), ORs or rates with 95% CIs.

Results: Sixty-seven studies (1 813 947 women) were included. Overall, in test-negative design studies, pregnant women fully vaccinated with any COVID-19 vaccine had 61% reduced odds of SARS-CoV-2 infection during pregnancy (OR 0.39, 95% CI 0.21 to 0.75; 4 studies, 23 927 women; I2=87.2%) and 94% reduced odds of hospital admission (OR 0.06, 95% CI 0.01 to 0.71; 2 studies, 868 women; I2=92%). In adjusted cohort studies, the risk of hypertensive disorders in pregnancy was reduced by 12% (RR 0.88, 95% CI 0.82 to 0.92; 2 studies; 115 085 women), while caesarean section was reduced by 9% (OR 0.91, 95% CI 0.85 to 0.98; 6 studies; 30 192 women). We observed an 8% reduction in the risk of neonatal intensive care unit admission (RR 0.92, 95% CI 0.87 to 0.97; 2 studies; 54 569 women) in babies born to vaccinated versus not vaccinated women. In general, vaccination during pregnancy was not associated with increased risk of adverse pregnancy or perinatal outcomes. Pain at the injection site was the most common side effect reported (77%, 95% CI 52% to 94%; 11 studies; 27 195 women).

Conclusion: COVID-19 vaccines are effective in preventing SARS-CoV-2 infection and related complications in pregnant women.

PROSPERO registration number: CRD42020178076.
Original languageEnglish
Article numbere014247
Number of pages12
JournalBMJ Global Health
Volume9
Issue number4
DOIs
Publication statusPublished - 4 Apr 2024

Bibliographical note

Funding:
This study/research is funded by the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC). The project was partially supported by German Federal Ministry of Health (BMG) COVID-19 research and development, Government of Canada, the US Government (American Rescue Plan Act (ARPA)-International Organizations and Programs (IO&P) Funds) support to WHO, and the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by WHO.

Keywords

  • vaccines
  • COVID-19
  • obstetrics

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