Sars-cov-2 (covid-19) mrna-1273 vaccine Pregnancy and Breastfeeding Warnings

Brand names: Moderna COVID-19 Vaccine, Spikevax, Spikevax PF

Medically reviewed by Drugs.com. Last updated on May 1, 2023.

Sars-cov-2 (covid-19) mrna-1273 vaccine Pregnancy Warnings

Animal studies have failed to reveal direct or indirect evidence of embryofetal development, parturition, postnatal development, or other pregnancy outcomes. There are no controlled data in human pregnancy. Observational studies in pregnant individuals during the first trimester did not show an increased risk for miscarriage; studies conducted during the second and third trimesters did not show an increase in adverse outcomes during pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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.

Use is considered acceptable.

AU TGA pregnancy category: B1
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

Sars-cov-2 (covid-19) mrna-1273 vaccine Breastfeeding Warnings

Use is considered acceptable.

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

Comments:
-Systemic exposure in lactating individuals is considered negligible.
-Observational data of lactating individuals did not show an increased risk of adverse effects in breastfed newborns or infants.

See references

Further information

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