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. 2023 Jun 19. Online ahead of print. doi: 10.1016/j.cmi.2023.06.015

Table 2.

Major, minor, and genetic congenital malformations among pregnant women exposed to an mRNA COVID-19 vaccine in the first trimester compared to pregnant women exposed in the second and third trimesters of pregnancy.

1st trimester exposure
2nd/3rd trimester exposure

n % 95%CI n=
1326
95%CI RR 95%CI adj. RRb 95%CI
n %
Congenital malformationa 1 0.81% 0.02 4.41 11 0.83% 0.41 1.48 0.89 0.12 6.80 1.01 0.13 7.73
 MAJOR 1 0.81% 0.02 4.41 6 0.45% 0.17 0.98 -
 Minor 0 - 5 0.38% 0.12 0.88 -
Genetic malformation 0 - 2 015% 0.02 0.54 -

RR: risk ratio.

adj. RR: adjusted risk ratio.

a

Congenital malformation classification (major + minor) according to the EUROCAT classification.

b

adjusted analysis on unbalanced potential confounders: maternal age >40 years, drug use, nulliparity, medical history (pulmonary, diabetes and renal disease), and obstetrical history (previous pregnancy fetal malformation).