Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of TICOVAC in pregnant women. Available human data are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy.
Developmental and reproductive toxicity studies in animals have not been conducted with TICOVAC.