"Abstract
Results: Analysis of 226,395 singleton pregnancies in Israel from 2016 to 2022 indicates that COVID-19 vaccination with dose 1 during weeks 8-13 was associated with higher-than-expected observed number of fetal losses of approximately 13 versus 9 expected for every 100 exposed pregnancies, i.e., nearly 3.9 (95% CI: [2.55-5.14]) additional fetal losses above expected per 100 pregnancies. Most of the excess fetal losses occurred after gestational week 20 and nearly half occurred after gestational week 25. Similarly, women vaccinated with dose 3 during weeks 8-13 exhibited a higher-than-expected number of fetal losses with nearly 1.9 (95% CI: 0.39-3.42]) additional fetal losses above expected per 100 pregnancies. In contrast, pregnant women vaccinated for influenza during weeks 8-27 exhibited a consistently lower-than-expected observed number of fetal losses, likely the result of healthy vaccinee bias. Women vaccinated for COVID-19 or influenza prior to pregnancy exhibited according-to-expected or lower-than-expected numbers of fetal losses.
Conclusion: The results provide evidence for a substantially higher-than-expected number of eventual fetal losses associated with COVID-19 vaccination during gestational weeks 8-13."
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