Meningococcal group acwy conjugate-group b vaccine (cvx 316) Pregnancy and Breastfeeding Warnings

Brand names: Penbraya

Medically reviewed by Drugs.com. Last updated on Jan 29, 2024.

Meningococcal group acwy conjugate-group b vaccine (cvx 316) Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Comments:
-A pregnancy exposure registry is available.

Animal studies have not been reported. There are no clinical or developmental toxicity studies on this vaccine in pregnant individuals. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this vaccine, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-390-2953.

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

Meningococcal group acwy conjugate-group b vaccine (cvx 316) Breastfeeding Warnings

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant.

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

Comments:
-The US CDC and several health professional organizations state that vaccines given to a nursing mother do not affect the safety of breastfeeding mothers or breastfed infants.
-Immunization of the mother during the third trimester of pregnancy increases the number of meningococcal antibodies in breast milk.
-Lactating or pregnant women who receive meningococcal vaccines had higher levels of secretory immunoglobulin A in their milk.
-Limited data indicate breastfeeding can enhance the infant's response to certain vaccine antigens.

See references

Further information

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

Medical Disclaimer