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

Clara Calvert, Jade Carruthers, Cheryl Denny, Jack Donaghy, Lisa E. M. Hopcroft, Leanne Hopkins, Anna Goulding, Laura Lindsay, Terry McLaughlin, Emily Moore, Bob Taylor, Maria Loane, Helen Dolk, Joan Morris, Bonnie Auyeung, Krishnan Bhaskaran, Cheryl L. Gibbons, Srinivasa Vittal Katikireddi, Maureen O’Leary, David McAllister, Ting Shi, Colin R. Simpson, Chris Robertson, Aziz Sheikh, Sarah J. Stock and Rachael Wood ()
Additional contact information
Clara Calvert: University of Edinburgh
Jade Carruthers: Public Health Scotland
Cheryl Denny: Public Health Scotland
Jack Donaghy: Public Health Scotland
Lisa E. M. Hopcroft: Public Health Scotland
Leanne Hopkins: Public Health Scotland
Anna Goulding: Public Health Scotland
Laura Lindsay: Public Health Scotland
Terry McLaughlin: Public Health Scotland
Emily Moore: Public Health Scotland
Bob Taylor: Public Health Scotland
Maria Loane: Ulster University
Helen Dolk: Ulster University
Joan Morris: University of London
Bonnie Auyeung: University of Edinburgh
Krishnan Bhaskaran: London School of Hygiene and Tropical Medicine
Cheryl L. Gibbons: Public Health Scotland
Srinivasa Vittal Katikireddi: Public Health Scotland
Maureen O’Leary: Public Health Scotland
David McAllister: University of Glasgow
Ting Shi: University of Edinburgh
Colin R. Simpson: University of Edinburgh
Chris Robertson: Public Health Scotland
Aziz Sheikh: University of Edinburgh
Sarah J. Stock: University of Edinburgh
Rachael Wood: University of Edinburgh

Nature Communications, 2023, vol. 14, issue 1, 1-11

Abstract: Abstract 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.

Date: 2023
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DOI: 10.1038/s41467-022-35771-8

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