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

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

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 numberCRD42020178076.

Citation

Fernández-García, S., Del Campo-Albendea, L., Sambamoorthi, D., Sheikh, J., Lau, K., Osei-Lah, N., Ramkumar, A., Naidu, H., Stoney, N., Sundaram, P., Sengupta, P., Mehta, S., Attarde, S., Maddock, S., Manning, M., Meherally, Z., Ansari, K., Lawson, H., Yap, M., Kew, T., …Thangaratinam, S. (2024). Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis. BMJ Global Health, 9(4), Article e014247. https://doi.org/10.1136/bmjgh-2023-014247

• Journal Article Type: Article
• Acceptance Date: Jan 26, 2024
• Online Publication Date: Apr 4, 2024
• Publication Date: 2024-03
• Deposit Date: Jan 13, 2025
• Publicly Available Date: Jan 13, 2025
• Journal: BMJ Global Health
• Electronic ISSN: 2059-7908
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 9
• Issue: 4
• Article Number: e014247
• DOI: https://doi.org/10.1136/bmjgh-2023-014247
• Keywords: Vaccines, Obstetrics, Covid-19, Humans, Cesarean Section, Pregnancy, Parturition, Infant, Infant, Newborn, Female, COVID-19, SARS-CoV-2, COVID-19 Vaccines
• Public URL: https://nottingham-repository.worktribe.com/output/33822312
• Publisher URL: https://gh.bmj.com/content/9/4/e014247
• PMID: 38580375