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November 12, 2022

What is the current knowledge on safe and effective therapies and preventive measures for individuals contemplating pregnancy and during pregnancy

Studies have shown heightened risk of severe disease during pregnancy. What is the current knowledge on safe and effective therapies and preventive measures for individuals contemplating pregnancy and during pregnancy? With increased morbidity and mortality rates with COVID-19 infection during pregnancy, reproductive safety decisions are currently based on misleading and incomplete clinical efficacy and safety information.

In detail, explain the applicability of 45 CFR 46(9), Subpart B on special protections and limitations for pregnant women, fetuses, and breastfeeding infants. Was the standard of care outlined in 45 CFT 46(9), Subpart B met specific to Covid 19 Vaccination for pregnant women, fetuses, and breastfeeding infants? Support your position with current, relevant and peer reviewed research.

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