Rsv vaccine, mrna Pregnancy and Breastfeeding Warnings

Brand names: mRESVIA

Medically reviewed by Drugs.com. Last updated on Jul 16, 2024.

Rsv vaccine, mrna Pregnancy Warnings

This drug is not indicated for use in patients younger than 60 years.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have failed to reveal evidence of fetal harm. After IM administration to female rats, no drug-related fetal malformations/variations and no adverse effects on postnatal development were observed with a formulation containing about twice the amount of nucleoside-modified messenger RNA (compared to a full human dose). There are no controlled data in human pregnancy.

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.

See references

Rsv vaccine, mrna Breastfeeding Warnings

This drug is not indicated for use in patients younger than 60 years.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---For preventative vaccines, the mother's underlying condition is susceptibility to disease prevented by the vaccine.
-Respiratory syncytial virus (RSV) vaccine has not been studied during breastfeeding.
-As with this drug, the other 2 available RSV vaccines do not contain live organisms; use of non-live vaccines is generally considered acceptable during breastfeeding.
-According to the US CDC and other experts, vaccines administered to a nursing mother do not affect the safety of breastfeeding for mothers or infants; breastfeeding is not a contraindication to RSV vaccine.

See references

Further information

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