Our re-analysis indicates a cumulative incidence of spontaneous abortion 7 to 8 times higher than the original authors’ results (p < 0.001) and the typical average for pregnancy loss during this time period. In light of these findings, key policy decisions have been made using unreliable and questionable data. We conclude that the claims made using these data on the safety of exposure of women in early pregnancy to mRNA-based vaccines to prevent COVID-19 are unwarranted.
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However, closer inspection of the 827 women in the denominator of this calculation reveals that between 700 to 713 women were exposed to the vaccine after the timeframe for recording the outcome had elapsed (up to 20 weeks of pregnancy). Hence, a re-analysis of these figures indicates a cumulative incidence of spontaneous abortion ranging from 82% (104/127) to 91% (104/114), 7–8 times higher than the original authors’ results.
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A high baseline rate of 26% was used for the historical comparison of spontaneous abortion risk, an estimate that includes clinically unrecognized pregnancies and differs substantially from the definition used in this study (clinically recognized pregnancies).[5] Comparable estimates of clinically recognized pregnancies, range from 8% to 15%.
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The study indicates that at least 81.9% (≥ 104/127) experienced spontaneous abortion following mRNA exposure before 20 weeks, and 92.3% (96/104) of spontaneous abortions occurred before 13 weeks’ gestation (Table 4, footnotes).[4]
This is a very high proportion of pregnancy loss observed in those exposed to the mRNA vaccination before 20 weeks’ gestation, ranging from 81.9–91.2% (n = 114–127), which is significantly different to baseline estimates from other studies (11.3%, n = 79,978 [6]; p < 0.001), being 7- to 8-fold higher than expected (p < 0.001).
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