Historically, pregnant and lactating women have been excluded from clinical and vaccine trials because of safety concerns for the mother and child. But that exclusion can pose its own risks, a point that’s been repeatedly raised by the Society of Maternal-Fetal Medicine and various medical professionals. “It’s common, and it’s a cause for concern,” says Fradin. “When the consequences of toxic medications DES and Thalidomide were noted in the 1940s and 1960s, in 1977 the FDA barred pregnant and lactating women from phase 1 and phase 2 studies. This was intended to increase the safety of pregnant women, embryos, and infants. However, functionally this leads to barriers including women of reproductive age in medical research, which leads to less knowledge, advancement, and innovation in women’s health.” It’s a problem that many national societies are working tirelessly to rectify in the future. “Many are advocating to ethically include pregnant and lactating women in future clinical trials, but until this is more commonplace, physicians and other healthcare practitioners will need to continue to monitor updates in the data to best inform their patients regarding the COVID-19 vaccines,” adds Leftwich. As of January, Pfizer announced plans to begin testing the vaccine in pregnant women in the coming months though none have been enrolled yet, and Moderna was beginning to monitor the potential side effects in women who were immunized via a registry.
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