Tick-borne encephalitis (inactivated) pediatric vaccine Pregnancy and Breastfeeding Warnings

Brand names: TicoVac Pediatric

Medically reviewed by Drugs.com. Last updated on Nov 13, 2022.

Tick-borne encephalitis (inactivated) pediatric vaccine Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have not been reported. 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.

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Tick-borne encephalitis (inactivated) pediatric vaccine Breastfeeding Warnings

Use is not a contraindication to breastfeeding.
-According to some authorities: This drug should be used only if clearly needed and the benefit outweighs the risk.

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

Comments:
-No data are available regarding the clinical use of this drug during breastfeeding.
-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 side 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 the disease prevented by the vaccine.
-This vaccine is inactivated and contains no live virus; thus, it cannot infect the mother or infant.
-According to the US CDC and several experts, vaccines administered to breastfeeding mothers do not affect the safety of nursing for mothers or infants.
-There have been no prior reports of a non-live vaccine causing infant adverse effects via breastfeeding.

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Further information

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