Abstract

“Consistent, clear messaging from professional societies, regulatory and funding agencies, physicians, public health and community leaders, and pregnant women themselves ... will help change the culture of fear and misinformation surrounding research and pregnancy.”Pregnant and lactating women are routinely excluded from clinical trials, including those of vaccines, despite being at increased risk from infectious diseases. The COVID-19 pandemic has brought this omission into the spotlight, with exclusion from clinical trials followed by low vaccination levels amongst pregnant women contributing to maternal and fetal deaths. We hope the pandemic will act as a wake-up call to implement longstanding recommendations to integrate pregnant and lactating women into clinical studies.

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