Spikevax JN.1 Use In Pregnancy & Lactation

Pregnancy: No data are available yet regarding the use of SARS-CoV-2 JN.1 mRNA during pregnancy.
However, a large amount of observational data from pregnant women vaccinated with Spikevax (original) during the second and third trimester has 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). Since differences between products are confined to the spike protein sequence, and there are no clinically meaningful differences in reactogenicity, SARS-CoV-2 JN.1 mRNA can be used during pregnancy.
Breast-feeding: No data are available yet regarding the use of SARS-CoV-2 JN.1 mRNA during breastfeeding.
However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to the vaccine is negligible. Observational data from women who were breastfeeding after vaccination with Spikevax (original) have not shown a risk for adverse effects in breastfed newborns/infants. SARS-CoV-2 JN.1 mRNA can be used during breastfeeding.
Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).