Lack of Compelling Safety data for mRNA COVID Vaccines in Pregnant Women

Lack of Compelling Safety data for mRNA COVID Vaccines in Pregnant Women

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

Peter A. McCullough, MD, MPH, FACC, FACP, FAHA, FASN, FNKF, FNLA, FCRSA, Professor of Medicine, Texas Christian University and the University of North Texas Health Sciences Center School of Medicine, Dallas, TX, [email protected]

Ira Bernstein, MD, CCFP, FCFP, University of Toronto, Toronto, ON, [email protected]

Sanja Jovanovic, MD, MSc Community Health and Epidemiology, The Evidence-Based Medicine Consultancy Ltd, Bath, UK, [email protected]

Deanna McLeod, HBSc, Principal, Kaleidoscope Strategic, [email protected]

Raphael B. Stricker, MD, Union Square Medical Associates, San Francisco, CA, [email protected]

Response to the Shimabukuro et al. (2021) NEJM Publication

The article by Shimabukuro et al. (2021) presents preliminary safety results of coronavirus 2019 (COVID-19) mRNA vaccines given to pregnant women from the V-Safe Registry.1 These findings are of particular importance, as pregnant women were excluded from the phase III trials assessing mRNA vaccines. 

In Table 4, the authors report a rate of spo...

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