Pregnant women and their fetuses, and breastfeeding infants are at increased risk of severe disease and death from many vaccine-preventable diseases, including COVID-19.

Pregnant women and their fetuses, and breastfeeding infants are at increased risk of severe disease and death from many vaccine-preventable diseases, including COVID-19. What are the recommendations on how pregnant and breastfeeding women should participate in future clinical research? US Regulators provide guidance on how pregnant women should be included in clinical trials and how vulnerability assessments should be conducted on pregnant and breastfeeding women. The US recommended pregnant and breastfeeding women receive COVID-19 vaccination. What is the risk benefit profile for pregnant and breast-feeding women for toxicity exposure to both the fetuses and breastfeeding infants post COVID-19 Inoculation.

Students are expected to support their Risk Benefit Profile with a formal Risk Assessment using FDA’s Benefit-Risk Framework Template. This should be included as an embedded table.