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

Calvert, Clara and Carruthers, Jade and Denny, Cheryl and Donaghy, Jack and Hopcroft, Lisa E. M. and Hopkins, Leanne and Goulding, Anna and Lindsay, Laura and McLaughlin, Terry and Moore, Emily and Taylor, Bob and Loane, Maria and Dolk, Helen and Morris, Joan and Auyeung, Bonnie and Bhaskaran, Krishnan and Gibbons, Cheryl L. and Katikireddi, Srinivasa Vittal and O’Leary, Maureen and McAllister, David and Shi, Ting and Simpson, Colin R. and Robertson, Chris and Sheikh, Aziz and Stock, Sarah J. and Wood, Rachael (2023) A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection. Nature Communications, 14 (1). 107. ISSN 2041-1723 (https://doi.org/10.1038/s41467-022-35771-8)

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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.