%0 Journal Article %A Alice Lu-Culligan %A Alexandra Tabachnikova %A Maria Tokuyama %A Hannah J. Lee %A Carolina Lucas %A Valter Silva Monteiro %A M. Catherine Muenker %A Subhasis Mohanty %A Jiefang Huang %A Insoo Kang %A Charles Dela Cruz %A Shelli Farhadian %A Melissa Campbell %A Inci Yildirim %A Albert C. Shaw %A Albert I. Ko %A Saad B. Omer %A Akiko Iwasaki %T No evidence of fetal defects or anti-syncytin-1 antibody induction following COVID-19 mRNA vaccination %D 2021 %R 10.1101/2021.12.07.471539 %J bioRxiv %P 2021.12.07.471539 %X The impact of coronavirus disease 2019 (COVID-19) mRNA vaccination on pregnancy and fertility has become a major topic of public interest. We investigated two of the most widely propagated claims to determine 1) whether COVID-19 mRNA vaccination of mice during early pregnancy is associated with an increased incidence of birth defects or growth abnormalities, and 2) whether COVID-19 mRNA-vaccinated human volunteers exhibit elevated levels of antibodies to the human placental protein syncytin-1. Using a mouse model, we found that intramuscular COVID-19 mRNA vaccination during early pregnancy at gestational age E7.5 did not lead to differences in fetal size by crown-rump length or weight at term, nor did we observe any gross birth defects. In contrast, injection of the TLR3 agonist and double-stranded RNA mimic polyinosinic-polycytidylic acid, or poly(I:C), impacted growth in utero leading to reduced fetal size. No overt maternal illness following either vaccination or poly(I:C) exposure was observed. We also found that term fetuses from vaccinated murine pregnancies exhibit high circulating levels of anti-Spike and anti-RBD antibodies to SARS-CoV-2 consistent with maternal antibody status, indicating transplacental transfer. Finally, we did not detect increased levels of circulating anti-syncytin-1 antibodies in a cohort of COVID-19 vaccinated adults compared to unvaccinated adults by ELISA. Our findings contradict popular claims associating COVID-19 mRNA vaccination with infertility and adverse neonatal outcomes.Competing Interest StatementThe authors have declared no competing interest. %U https://www.biorxiv.org/content/biorxiv/early/2021/12/08/2021.12.07.471539.full.pdf