A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection

Calvert, C. et al. (2023) A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection. Nature Communications, 14, 107. (doi: 10.1038/s41467-022-35771-8) (PMID:36609574) (PMCID:PMC9821346)

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Evidence on associations between COVID-19 vaccination or SARS-CoV-2 infection and the risk of congenital anomalies is limited. Here we report a national, population-based, matched cohort study using linked electronic health records from Scotland (May 2020-April 2022) 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 major congenital anomaly and [2] any non-genetic major congenital anomaly. 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 6731 babies whose mothers were vaccinated in the pregnancy exposure period, 153 had any anomaly and 120 had a non-genetic anomaly. Primary analyses find no association between any 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 find 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 are robust to sensitivity analyses. These data provide reassurance on the safety of vaccination, in particular mRNA vaccines, just before or in early pregnancy.

Item Type:Articles
Additional Information:Acknowledgements: COPS is a sub-study of EAVE II, which is funded by the Medical Research Council (MC_PC_19075) (A.S.) with the support of BREATHE - The Health Data Research Hub for Respiratory Health [MC_PC_19004] (A.S.), which is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. COPS has received additional funding from Tommy’s charity (S.J.S.). S.J.S. is funded by a Wellcome Trust Clinical Career Development Fellowship (209560/Z/17/Z). S.V.K. acknowledges funding from a NRS Senior Clinical Fellowship (SCAF/15/02), the Medical Research Council (MC_UU_00022/2) and the Scottish Government Chief Scientist Office (SPHSU17). K.B. is funded by a Wellcome Senior Research Fellowship (220283/Z/20/Z).
Glasgow Author(s) Enlighten ID:McAllister, Professor David and Katikireddi, Professor Vittal
Authors: Calvert, C., Carruthers, J., Denny, C., Donaghy, J., Hopcroft, L. E.M., Hopkins, L., Goulding, A., Lindsay, L., McLaughlin, T., Moore, E., Taylor, B., Loane, M., Dolk, H., Morris, J., Auyeung, B., Bhaskaran, K., Gibbons, C. L., Katikireddi, S. V., O’Leary, M., McAllister, D., Shi, T., Simpson, C. R., Robertson, C., Sheikh, A., Stock, S. J., and Wood, R.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health
Journal Name:Nature Communications
Publisher:Nature Research
ISSN (Online):2041-1723
Copyright Holders:Copyright © 2023 The Authors
First Published:First published in Nature Communications 14: 107
Publisher Policy:Reproduced under a Creative Commons license

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
172690Understanding the impacts of welfare policy on health: A novel data linkage studySrinivasa KatikireddiOffice of the Chief Scientific Adviser (CSO)SCAF/15/02HW - Public Health
3048231Inequalities in healthAlastair LeylandMedical Research Council (MRC)MC_UU_00022/2HW - MRC/CSO Social and Public Health Sciences Unit
3048231Inequalities in healthAlastair LeylandOffice of the Chief Scientific Adviser (CSO)SPHSU17HW - MRC/CSO Social and Public Health Sciences Unit