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

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.
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1038/s41467-022-35771-8

Authors


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Role:
Author
ORCID:
0000-0003-3272-1040
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Role:
Author
ORCID:
0000-0003-4616-4732
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Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
ORCID:
0000-0002-7022-1322


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Funder identifier:
https://ror.org/029chgv08
Grant:
209560/Z/17/Z
220283/Z/20/Z
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Funder identifier:
https://ror.org/03x94j517
Grant:
MC_PC_19075
MC_UU_00022/2
MC_PC_19004


Publisher:
Springer Nature
Journal:
Nature Communications More from this journal
Volume:
14
Issue:
1
Article number:
107
Place of publication:
England
Publication date:
2023-01-06
Acceptance date:
2022-12-22
DOI:
EISSN:
2041-1723
ISSN:
2041-1723
Pmid:
36609574


Language:
English
Pubs id:
1318566
Local pid:
pubs:1318566
Deposit date:
2024-09-27

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