Pneumococcal 20-valent conjugate vaccine Pregnancy and Breastfeeding Warnings

Brand names: Prevnar 20

Medically reviewed by Drugs.com. Last updated on Feb 23, 2024.

Pneumococcal 20-valent conjugate vaccine Pregnancy Warnings

According to some authorities: This vaccine should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
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:
-There are no adequate and well-controlled studies on this vaccine in pregnant women.

Animal studies have failed to reveal evidence of teratogenicity. When administered to female rabbits before mating and during gestation, no adverse effects on pre-weaning development, vaccine-related fetal malformation, or variations were observed. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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

Pneumococcal 20-valent conjugate vaccine Breastfeeding Warnings

A study examined mothers who received the 23-valent pneumococcal polysaccharide vaccine. Those who received the vaccination during pregnancy or within 72 hours postpartum retained secretory immunoglobulin A and immunoglobulin G in their breast milk for at least 7 months after the vaccination.

Some evidence indicates that breastfed infants of vaccinated mothers are less likely to contract pneumococcal disease. Infants breastfed for longer than 90 days have a better antibody response to some of the pneumococcal strains in the vaccine at 13 months of age than those breastfed for less than 90 days.

Use is generally considered acceptable.

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 a mother during the third trimester of pregnancy markedly increases the number of pneumococcal antibodies in breast milk.
-Limited data indicate that breastfeeding can enhance the infant's response to certain vaccine antigens.

See references

Further information

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