No randomized trial data are available for use of the COVID-19 shot in pregnant women, and Pfizer cut its pregnancy trial short.1 But this doesn’t stop the U.S. Centers for Disease Control and Prevention from recommending COVID-19 injections for everyone 6 months and older, including “people who are pregnant, breastfeeding, trying to get pregnant now, or those who might become pregnant in the future.”2
“Not having any good data didn’t seem to bother the CDC,” Dr. Martin Makary, a professor at Johns Hopkins University School of Medicine, wrote in Tablet.3 He and a team of scientists petitioned the U.S. Food and Drug Administration to add a disclaimer to the shot’s label about the lack of trial data on its safety in pregnant women. The FDA declined, stating that this information wouldn’t be relevant.
Pregnant women, however, do need to know about the shot’s lack of testing during pregnancy — it’s the foundation of informed consent. They’d also likely be interested to know why Pfizer stopped its pregnancy trial early and has yet to make the results it did find public.
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