Animal studies have not been reported. In a controlled trial, pregnant individuals who received an investigational unadjuvanted respiratory syncytial virus (RSV) vaccine that contain the same RSVPreF3 antigen as this vaccine experienced a 6.8% increase in preterm births compared to those who received a placebo. 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 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. No data is available on this drug's use in pregnant women to inform a drug-related risk.

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No human or animal 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.

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

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

See references