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 McallisterTing Shi, Colin R Simpson, Chris Robertson, Aziz Sheikh, Sarah J Stock, Rachael Wood*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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 6,731 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.
Original languageEnglish
Article number107
JournalNature Communications
Issue number1
Publication statusPublished - 6 Jan 2023

Keywords / Materials (for Non-textual outputs)

  • BNT162 Vaccine
  • COVID-19 Vaccines/adverse effects
  • COVID-19/epidemiology
  • Cohort Studies
  • Female
  • Humans
  • Pregnancy
  • SARS-CoV-2/genetics
  • Vaccination/adverse effects


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