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

Calvert, ClaraORCID logo; Carruthers, Jade; Denny, CherylORCID logo; Donaghy, Jack; Hopcroft, Lisa EMORCID logo; Hopkins, LeanneORCID logo; Goulding, AnnaORCID logo; Lindsay, Laura; McLaughlin, Terry; Moore, EmilyORCID logo; +16 more...Taylor, BobORCID logo; Loane, MariaORCID logo; Dolk, Helen; Morris, JoanORCID logo; Auyeung, BonnieORCID logo; Bhaskaran, KrishnanORCID logo; Gibbons, Cheryl L; Katikireddi, Srinivasa VittalORCID logo; O'Leary, MaureenORCID logo; McAllister, David; Shi, TingORCID logo; Simpson, Colin RORCID logo; Robertson, Chris; Sheikh, AzizORCID logo; Stock, Sarah JORCID logo; and Wood, RachaelORCID logo (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 DOI: 10.1038/s41467-022-35771-8
Copy

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.


picture_as_pdf
Calvert-etal-2023-A-population-based-matched-cohort-study-of-major-congenital-anomalies-following-COVID-19-vaccination-and-SARS-CoV-2-infection.pdf
subject
Published Version
Available under Creative Commons: Attribution 4.0

View Download

Atom BibTeX OpenURL ContextObject in Span Multiline CSV OpenURL ContextObject Dublin Core Dublin Core MPEG-21 DIDL Data Cite XML EndNote HTML Citation JSON MARC (ASCII) MARC (ISO 2709) METS MODS RDF+N3 RDF+N-Triples RDF+XML RIOXX2 XML Reference Manager Refer Simple Metadata ASCII Citation EP3 XML
Export

Downloads