In a controlled trial, 5.7% of pregnant individuals who received a dose of this vaccine at 24 through 36 weeks' gestation experienced preterm births compared to 4.7% who received a placebo. The study showed no significant difference between the groups in cases of congenital malformations and fetal deaths. In an animal study where rabbits were exposed to high doses, there were no effects on embryo-fetal development.

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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: This vaccine is not approved for individuals less than 60 years of age.
Based on data from clinical studies, this vaccine can potentially increase the risk of preterm birth.

Comments:
Human and animal studies revealed no evidence of vaccine-associated congenital anomalies or fetal deaths.

See references

The manufacturer makes no recommendation regarding use during lactation.

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

Comments: This vaccine is not approved for use in persons less than 60 years of age. The effects in the nursing infant are unknown.

No data are available to assess the effects of this vaccine on the breastfed infant or on milk production. The benefits of breastfeeding, the mother's clinical need for this drug, and potential adverse effects on the breastfed child should be considered prior to administration.

See references