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COVID-19 vaccination could potentially offer significant benefits to pregnant women, who are at an increased risk of severe illness and death from COVID-19, and to their unborn babies, who are more likely to suffer adverse outcomes than are babies who weren’t exposed to the virus in utero. There has been uncertainty around the risks and benefits of vaccinating pregnant women for COVID-19 because they were excluded from the initial clinical trials for the Moderna and Pfizer/BioNTech vaccines currently available under emergency use authorization in the US.
Clinical trials are now getting underway to address COVID-19 vaccine safety and efficacy in pregnant women. Last week (February 18), Pfizer and BioNTech announced a global Phase 2/3 trial of their COVID-19 vaccine in 4,000 healthy pregnant women. The placebo-controlled, observer-blinded study will track the safety, tolerability, and immunogenicity of two doses of vaccine 21 days apart, compared to placebo, ...