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Developmental and reproductive safety of AZD1222 (ChAdOx1 nCoV-19) in mice. | LitMetric

AI Article Synopsis

  • A non-clinical study on female CD-1 mice assessed the vaccine's effects on fertility and reproduction, finding no negative impacts on reproduction, fetal development, or pup survival.
  • Antibody responses were observed in both the mothers and their offspring, suggesting that the vaccine can effectively transfer immune protection through the placenta and breast milk.

Article Abstract

AZD1222 (ChAdOx1 nCoV-19) is a COVID-19 vaccine that is not yet licensed for use during pregnancy. To support the inclusion of pregnant and breastfeeding people in AZD1222 clinical studies, a non-clinical developmental and reproductive toxicity study was performed to evaluate its effects on fertility and reproductive processes of female CD-1 mice during the embryofetal development phase, and postnatal outcomes during the littering phase. Immunogenicity assessments were also made in dams, fetuses, and pups. There were no vaccine-related unscheduled deaths throughout the study. Furthermore, there were no vaccine-related effects on female reproduction, fetal or pup survival, fetal external, visceral, or skeletal findings, pup physical development, and no abnormal gross pathology findings in pups or dams. Antibody responses raised in dams were maintained throughout gestation and postnatal periods, and seroconversion in fetuses and pups indicate placental and lactational transfer of immunoglobulins. Together with clinical data from non-pregnant people, these results support the inclusion of pregnant and breastfeeding people in AZD1222 clinical studies.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9759091PMC
http://dx.doi.org/10.1016/j.reprotox.2021.07.010DOI Listing

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