A study of pregnant women in Israel who received the COVID-19 vaccination during the first trimester of pregnancy has been released in a preprint PDF – ie, it hasn’t been through peer review. The vaccine used in Israel was almost entirely the Pfizer BNT162b2 mRNA vaccine.
Pregnant women were excluded from the pivotal randomized clinical trials used for the initial regulatory approvals of the COVID-19 vaccines. Not testing a drug during the first trimester of pregnancy when the fetus is at greatest risk for a developmental abnormality shows how panicked and bereft of judgment both the medical profession and the leaders of governments were during the late pandemic. This failure is even worse given that healthy young women, pregnant or not, are at very low risk for serious morbidity or death from COVID. Furthermore, the vaccine was an mRNA product, one that was new to immunological prophylaxis.
A summary of the findings of this investigation is shown below. Fetal loss increased by almost 30%. This increase was highly statistically significant. Importantly, there was no increase in fetal loss in pregnant women who received the influenza vaccine during the first trimester
The conclusion of the authors is: Overall, the findings in this paper provided concerning evidence of a higher-than-expected fetal loss rate associated with mRNA COVID-19 vaccine doses received during early pregnancy (gestational weeks 8-13). The safety signal should be further investigated by regulatory authorities as part of their risk assessment of vaccination during pregnancy with specific focus on the physiological effects in early pregnancy. There is also a need to conduct pathophysiological studies to better understand the potential biological mechanisms. Additionally, it would be insightful to assess the potential impact of non-mRNA COVID-19 vaccines. The findings also underscore the importance of conducting dedicated and statistically powered prospective clinical trials to study the impact of vaccination for COVID-19 and other pathogens during pregnancy to better inform recommendations to this vulnerable population.
These findings are another reminder that if we don’t keep a cool head when an unexpected event of great stress and confusion hits that we are likely to lose our overheated minds. There’s no doubt that our leaders in multiple realms of authority made a bad situation worse during the pandemic. The complete study is below.
