COVID-19 vaccination and SARS-CoV-2 infection in early pregnancy and the risk of major congenital anomalies: a national population-based cohort study

Author:

Wood Rachael1,Calvert Clara2ORCID,Carruthers Jade3,Denny Cheryl3ORCID,Donaghy Jack3,Hopcoft Lisa4ORCID,Hopkins Leanne3ORCID,Goulding Anna3ORCID,Lindsay Laura3,McLaughlin Terry3,Moore Emily5ORCID,Taylor John3ORCID,Loane Maria6,Dolk Helen6,Morris Joan7,Auyeung Bonnie8ORCID,Bhaskaran Krishnan9ORCID,Gibbons Cheryl3,Katikireddi Srinivasa10ORCID,O’Leary Maureen11,McAllister David10,Shi Ting12ORCID,Simpson Colin13ORCID,Robertson Chris14,Sheikh Aziz8ORCID,Stock Sarah15ORCID

Affiliation:

1. Public Health Scotland; Usher Institute, University of Edinburgh

2. Centre for Global Health, Usher Institute, University of Edinburgh

3. Public Health Scotland

4. Institute of Cancer Sciences, University of Glasgow

5. Public Health Scotland, Glasgow

6. Ulster University

7. University of London

8. University of Edinburgh

9. London School of Hygiene and Tropical Medicine

10. University of Glasgow

11. Public Health Scotland, Glasgow, UK

12. Usher Institute, University of Edinburgh

13. Victoria University of Wellington

14. Department of Mathematics and Statistics, University of Strathclyde, Glasgow, UK

15. University of Edinburgh Usher Institute

Abstract

Abstract Evidence on associations between COVID-19 vaccination or SARS-CoV-2 infection and the risk of congenital anomalies is limited. We conducted a national, population-based, matched cohort study to estimate the association between COVID-19 vaccination and, separately, SARS-CoV-2 infection between six weeks pre-conception and 19 weeks and six days gestation and the risk of [1] any congenital anomaly and; [2] non-genetic anomalies. Mothers vaccinated in this pregnancy exposure period mostly received an mRNA vaccine (73.7% Pfizer-BioNTech BNT162b2 and 7.9% Moderna mRNA-1273). Of the 6,731 babies whose mothers were vaccinated in the pregnancy exposure period, 153 had any congenital anomaly and 120 had a non-genetic anomaly. Primary analyses found no association between vaccination and any anomaly (adjusted Odds Ratio [aOR] = 1.01, 95% Confidence Interval [CI] = 0.83–1.24) or non-genetic anomalies (aOR = 1.00, 95% CI = 0.81–1.22). Primary analyses also found no association between SARS-CoV-2 infection and any anomaly (aOR = 1.02, 95% CI = 0.66–1.60) or non-genetic anomalies (aOR = 0.94, 95% CI = 0.57–1.54). Findings were robust to sensitivity analyses. These data provide reassurance on the safety of vaccination, in particular mRNA vaccines, just before or in early pregnancy.

Publisher

Research Square Platform LLC

Reference43 articles.

1. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis;Allotey J;Bmj,2020

2. Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection: The INTERCOVID Multinational Cohort Study;Villar J;JAMA Pediatrics,2021

3. SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland;Stock SJ;Nat Med,2022

4. GOV.UK. Over half of pregnant women have now had one or more doses of COVID-19 vaccines. (Accessed 28 September 2022 at: https://www.gov.uk/government/news/over-half-of-pregnant-women-have-now-had-one-or-more-doses-of-covid-19-vaccines). 2022.

5. Public Health Scotland. Public Health Scotland COVID-19 Statistical Report As at 26 September 2022. (Accessed 28 September 2022 at: https://www.publichealthscotland.scot/media/15346/2022-09-28-covid-19-publication_report.pdf). 2022.

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