Table 2.
Descriptive information on vaccination (vaccinated group only) and on the risk and types of major congenital anomalies in the vaccinated and controls groups
| Vaccinated cohort | Unvaccinated controls | |
|---|---|---|
| Exposure (vaccination) | ||
| Gestation at first vaccination within exposure period* | ||
| Up to six weeks preconception | 2045 (30.4%) | — |
| 2 + 0-9 + 6 weeks | 1925 (28.6%) | — |
| 10 + 0-13 + 6 weeks | 893 (13.3%) | — |
| 14 + 0-19 + 6 weeks | 1868 (27.8%) | — |
| Number of vaccinations within exposure period | ||
| 1 | 4871 (72.4%) | — |
| 2+ | 1860 (27.6%) | — |
| Dose number at first vaccination within exposure period | ||
| Dose 1 | 5516 (81.9%) | — |
| Dose 2 | 1204 (17.9%) | — |
| Dose 3 | 11 (0.2%) | — |
| Type of vaccination within exposure period | ||
| BNT162b2 | 4963 (73.7%) | — |
| mRNA-1273 | 535 (7.9%) | — |
| ChAdOx1-S/nCoV-19 | 1222 (18.2%) | — |
| 1+ different type | 11 (0.2%) | — |
| Outcome (major congenital anomaly) | ||
| Total N babies with any anomaly | 153 | 467 |
| Total N live births with any anomaly | 110 | 335 |
| Total live birth prevalence of any anomaly (/1000 live births) | 17.1 | 17.3 |
| Total N babies with non-genetic anomaly | 120 | 375 |
| Total N live births with non-genetic anomaly | 94 | 295 |
| Total live birth prevalence of non-genetic anomaly (/1000 live births) | 14.6 | 15.2 |
| N (%) babies with the following types of anomaly [N with non-genetic anomaly] | ||
| Nervous system | 14 (9.2%) [13] | 43 (9.2%) [41] |
| Eye | 2 (1.3%) [2] | 1 (0.2%) [0] |
| Ear, face and neck | 2 (1.3%) [2] | 2 (0.4%) [2] |
| Congenital heart defects | 41 (26.8%) [35] | 105 (22.5%) [84] |
| Respiratory | 1 (0.7%) [1] | 5 (1.1%) [5] |
| Oro-facial clefts | 7 (4.6%) [3] | 16 (3.4%) [13] |
| Digestive system | 13 (8.5%) [12] | 45 (9.6%) [38] |
| Abdominal wall defects | 3 (2.0%) [3] | 6 (1.3%) [6] |
| Urinary | 11 (7.2%) [7] | 31 (6.6%) [30] |
| Genital | 15 (9.8%) [14] | 43 (9.2%) [41] |
| Limb defect | 23 (15.0%) [22] | 75 (16.1%) [73] |
| Other anomalies/syndromes** | 18 (11.8%) [9] | 30 (6.4%) [18] |
| Chromosomal | 24 (15.7%) [0] | 80 (17.1%) [0] |
*Between 6 weeks preconception and up to the earliest of: (1) end of pregnancy or (2) 19 weeks 6 days gestation.
**The “Other anomalies/syndromes group” includes a disparate range of conditions including genetic syndromes and microdeletions, skeletal dysplasias, and recognised teratogenic syndromes and associations. No unusual pattern in the distribution of these other anomalies was seen in the vaccinated group.