Comirnaty Use In Pregnancy & Lactation

3 mcg: Comirnaty JN.1 (3 micrograms)/dose concentrate for dispersion for injection is not intended for individuals older than 5 years of age.
For details for use in individuals older than 5 years of age, please refer to the monograph for those formulations.
10 mcg/30 mcg: Pregnancy: No data are available yet regarding the use of Comirnaty JN.1 during pregnancy.
However, a large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Based on data available with other vaccine variants, Comirnaty JN.1 can be used during pregnancy.
Breast-feeding: No data are available yet regarding the use of Comirnaty JN.1 during breast-feeding.
However, no effects on the breast-fed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to the vaccine is negligible. Observational data from women who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breast-fed newborns/infants. Comirnaty JN.1 can be used during breast-feeding.
Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).