You are here

  • Home
  • Archive
  • Volume 9, Issue 4
  • Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis

Article Text

Article menu
Original research
Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis
  1. Silvia Fernández-García1,
  2. Laura del Campo-Albendea2,3,
  3. Dharshini Sambamoorthi4,
  4. Jameela Sheikh4,
  5. Karen Lau4,
  6. Nana Osei-Lah4,
  7. Anoushka Ramkumar4,
  8. Harshitha Naidu4,
  9. Nicole Stoney4,
  10. Paul Sundaram4,
  11. Paulomi Sengupta5,
  12. Samay Mehta4,
  13. Shruti Attarde4,
  14. Sophie Maddock4,
  15. Millie Manning4,
  16. Zainita Meherally6,
  17. Kehkashan Ansari4,
  18. Heidi Lawson4,
  19. Magnus Yap4,
  20. Tania Kew4,
  21. Andriya Punnoose4,
  22. Chloe Knight4,
  23. Eyna Sadeqa4,
  24. Jiya Cherian4,
  25. Sangamithra Ravi4,
  26. Wentin Chen4,
  27. Kate Walker5,
  28. Keelin O’Donoghue7,
  29. Madelon van Wely8,
  30. Elizabeth van Leeuwen9,
  31. Elena Kostova8,
  32. Heinke Kunst10,11,
  33. Asma Khalil12,
  34. Vanessa Brizuela13,
  35. Edna Kara13,
  36. Caron Rahn Kim13,
  37. Anna Thorson13,
  38. Olufemi T Oladapo13,
  39. Lynne Mofenson14,
  40. Sami L Gottlieb13,
  41. Mercedes Bonet13,
  42. Ngawai Moss15,
  43. Javier Zamora1,2,3,16,
  44. John Allotey1,16,
  45. Shakila Thangaratinam1,16,17
  46. on behalf of the PregCOV-19 Living Systematic Review Consortium
    1. 1WHO Collaborating Centre for Global Women’s Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK
    2. 2Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Madrid, Spain
    3. 3CIBERESP, Madrid, Spain
    4. 4University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
    5. 5University of Nottingham, Nottingham, UK
    6. 6University of Aberdeen, Aberdeen, UK
    7. 7University College Cork, Cork, Ireland
    8. 8Amsterdam UMC Location AMC Center for Reproductive Medicine, Amsterdam, The Netherlands
    9. 9Amsterdam UMC Location AMC Department of Obstetrics Gynecology, Amsterdam, The Netherlands
    10. 10Queen Mary University of London Blizard Institute, London, UK
    11. 11Barts Health NHS Trust, London, UK
    12. 12St George’s University of London, London, UK
    13. 13Department of Reproductive Health and Research, World Health Organization, Geneve, Switzerland
    14. 14Research, Elizabeth Glaser Pediatric AIDS Foundation, Washington, District of Columbia, USA
    15. 15Katie's Team, London, UK
    16. 16NIHR Birmingham Biomedical Centre (BRC), University Hospitals Birmingham, Birmingham, UK
    17. 17Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, UK
    1. Correspondence to Dr Shakila Thangaratinam; s.thangaratinam.1{at}bham.ac.uk

    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.

    • COVID-19
    • vaccines
    • obstetrics

    Data availability statement

    No data are available.

    https://creativecommons.org/licenses/by/3.0/igo/

    This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (CC BY 3.0 IGO), which permits use, distribution,and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article’s original URL.

    https://doi.org/10.1136/bmjgh-2023-014247

    Statistics from Altmetric.com

      Request Permissions

      If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

      Data availability statement

      No data are available.

      View Full Text

      Supplementary materials

      Footnotes

      • Handling editor Seema Biswas

      • Twitter @medstudentjam

      • Collaborators PregCOV-19 Living Systematic Review Consortium: Adeolu Banjoko, Alya Khashaba, Ankita Gupta, Anna Clave Llavall, Anushka Dixit, Damilola Akande, Dengyi Zhou, Halimah Khalil, Helen Fraser, Kathryn Barry, Kehkashan Ansari, Luke Debenham, Massa Mamey, Maurie Kumaran, Megan Littmoden, Meghnaa Hebbar, Rishab Balaji, Shaunak Chatterjee, Sulemana Saibu, Tanisha Rajah, Yasmin King, 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 Yap, Tania 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 Gottlieb, Mercedes Bonet, Ngawai Moss, Javier Zamora, John Allotey and Shakila Thangaratinam.

      • Contributors ST, MB and JA conceptualised the study. DS, JS, KL, NO-L, AR, HN, NS, PSu, SMe, PSe, SA, SMa, MM, ZM, HL, MY and TK selected the studies. SF-G, DS, KL, NO-L, AP, CK, ES, JC, SR and WC extracted the data. SF-G, LdC-A and JZ conducted the analyses. All coauthors contributed to the writing of the manuscript and approved the final version. ST, JA and JZ are the guarantors. All members of the PregCOV-19 Living Systematic Review Consortium contributed to study selection and data extraction. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

      • 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.

      • Disclaimer The author is a staff member of the World Health Organization. The author alone is responsible for the views expressed in this publication and they do not necessarily represent the views, decisions or policies of the World Health Organization.

        The views expressed are those of the author(s) and not necessarily those of WHO, UK NIHR or the Department of Health and Social Care.

      • Competing interests None declared.

      • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the 'Methods' section for further details.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.