TY - JOUR
T1 - Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes
T2 - a systematic review and meta-analysis
AU - PregCOV-19 Living Systematic Review Consortium
AU - Fernández-García, Silvia
AU - del Campo-Albendea, Laura
AU - Sambamoorthi, Dharshini
AU - Sheikh, Jameela
AU - Lau, Karen
AU - Osei-Lah, Nana
AU - Ramkumar, Anoushka
AU - Naidu, Harshitha
AU - Stoney, Nicole
AU - Sundaram, Paul
AU - Sengupta, Paulomi
AU - Mehta, Samay
AU - Attarde, Shruti
AU - Maddock, Sophie
AU - Manning, Millie
AU - Meherally, Zainita
AU - Ansari, Kehkashan
AU - Lawson, Heidi
AU - Yap, Magnus
AU - Kew, Tania
AU - Punnoose, Andriya
AU - Knight, Chloe
AU - Sadeqa, Eyna
AU - Cherian, Jiya
AU - Ravi, Sangamithra
AU - Chen, Wentin
AU - Walker, Kate
AU - O’Donoghue, Keelin
AU - van Wely, Madelon
AU - van Leeuwen, Elizabeth
AU - Kostova, Elena
AU - Kunst, Heinke
AU - Khalil, Asma
AU - Brizuela, Vanessa
AU - Kara, Edna
AU - Kim, Caron Rahn
AU - Thorson, Anna
AU - Oladapo, Olufemi T.
AU - Mofenson, Lynne
AU - Gottlieb, Sami L
AU - Bonet, Mercedes
AU - Moss, Ngawai
AU - Zamora, Javier
AU - Allotey, John
AU - Thangaratinam, Shakila
N1 - 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.
PY - 2024/4/4
Y1 - 2024/4/4
N2 - 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.
AB - 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.
KW - vaccines
KW - COVID-19
KW - obstetrics
U2 - 10.1136/bmjgh-2023-014247
DO - 10.1136/bmjgh-2023-014247
M3 - Review article
SN - 2059-7908
VL - 9
JO - BMJ Global Health
JF - BMJ Global Health
IS - 4
M1 - e014247
ER -