Rsv vaccine, pref a-pref b, recombinant Pregnancy and Breastfeeding Warnings

Brand names: Abrysvo

Rsv vaccine, pref a-pref b, recombinant Pregnancy Warnings

This vaccine is indicated for pregnant individuals at 32 through 36 weeks gestational age.
-According to some authorities: This vaccine may be administered to pregnant individuals as early as 28 weeks.

US FDA pregnancy category: Not assigned.

Risk summary: Studies revealed no evidence of vaccine-associated congenital anomalies or fetal deaths.

Comments:
-Available data are insufficient to establish or exclude a causal relationship between preterm birth and this vaccine.
-This vaccine has not been studied in pregnant individuals less than 24 weeks gestational age, and those at increased risk for preterm birth.
-A pregnancy exposure registry is available.

Animal developmental studies have failed to reveal evidence of harm to the fetus or to postnatal survival, growth, or development.

In a controlled trial, 6% of pregnant individuals who received a dose of this vaccine at 24 through 36 weeks gestation experienced preterm births compared to 5% who received a placebo. The study showed no significant difference between the groups in cases of congenital malformations and fetal deaths.

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 healthcare 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, pref a-pref b, recombinant Breastfeeding Warnings

This vaccine has been used without apparent harmful effects.

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

Comments:
-No data are available to assess the effects of this vaccine on the breastfed infant or milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this vaccine and potential adverse effects on the infant.
-The US CDC and several health professional organizations state that vaccines given to a nursing mother do not affect breastfeeding safety for mothers or infants.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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