8 USE IN SPECIFIC POPULATIONS
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.
Human data are not available to assess the impact of TICOVAC on milk production, its presence in breast milk, or its effects on the breastfed. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TICOVAC and any potential adverse effects on the breastfed child from TICOVAC or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
8.4 Pediatric Use
Safety and effectiveness of TICOVAC have not been established in infants below 1 year of age.
8.5 Geriatric Use
Clinical studies of TICOVAC did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. A clinical study (Study 690601, NCT00460486) of TICOVAC enrolled 73 subjects 60 years of age and older, including 31 subjects 65 years of age and older.