By Peter A. McCullough, MD, MPH
Colleagues:
After much discussion and input from excellent C19 clinical scientists, we have published this OPED on COVID-19 vaccination in pregnant women.
“We therefore suggest that it would be more appropriate for the authors to exercise the precautionary principle and conclude that the “mRNA COVID-19 vaccines may be associated with severe adverse events; their effect on pregnancy outcomes, especially when administered in early pregnancy, have yet to be determined and their use should be limited to clinical trials.
Given that the V-safe registry is the best source of vaccine safety data in pregnant women, we request that the authors make the data available for public scrutiny, conduct a temporal association analysis to explore vaccine-related events in pregnant women, and calculate Sab rates based on cohorts at risk of the event, especially when the vaccines are given in early pregnancy.
Thus, according to the Requirements for Pregnancy and Lactation Labeling by the US DHHS and the FDA the vaccines should contain a narrative summary equivalent to a “Category X” labeling in pregnancy, indicating that the potential risks involved in use of the COVID-19 vaccine in pregnant women clearly outweigh any future benefits since COVID-19 is mild and treatable for the majority of pregnant women.”
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