Details

Autor(en) / Beteiligte

• Stebbings, Richard
• Maguire, Shaun
• Armour, Gillian
• Jones, Christopher
• Goodman, Joanne
• Maguire, Anna Karin
• Tang, Chi Man
• Skellett, Vicky
• Harris, Jayne

Titel

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

Ist Teil von

• Reproductive toxicology (Elmsford, N.Y.), 2021-09, Vol.104, p.134-142

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2021

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• •Compared with placebo, AZD1222 did not affect fertility or reproduction in mice.•No evidence of AZD1222-related effects on pup/fetal development or survival was seen.•Antibodies raised in dams by AZD1222 endured through gestation and postnatal stages.•Seroconversion in fetuses and pups occurred following vaccination of dams.•Placental and lactational transfer of maternal immunoglobulins is suggested. 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.