Comirnaty Use In Pregnancy & Lactation

Pregnancy: There are limited amount of clinical study data from the use of COMIRNATY (Original) in pregnant women. 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). Administration of COMIRNATY in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
No clinical study data are available regarding the use of variant-adapted COMIRNATY during pregnancy.
Breast-feeding: It is unknown whether COMIRNATY is excreted in human milk.
No clinical study data are available regarding the use of variant-adapted COMIRNATY during breast-feeding.
Fertility: It is unknown whether COMIRNATY has an impact on fertility. Animal studies conducted with COMIRNATY (Original) do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).