Animal studies of a dose equivalent to a single human dose given on 4 occasions (twice prior to mating and twice during gestation) showed no evidence of developmental harm to the fetus. There are no controlled data in human pregnancy.

There is a pregnancy exposure registry that is monitoring pregnancy outcomes in patients exposed to this vaccine during pregnancy; patients vaccinated during pregnancy are encouraged to enroll in the registry by calling: 1-866-MODERNA (1866-663-3762).

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: There are insufficient data available on use of this drug in pregnancy to inform a drug related risk.

See references

This drug should be used only if clearly needed.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references