Rsv vaccine pref3, recombinant Pregnancy and Breastfeeding Warnings

Brand names: Arexvy

Rsv vaccine pref3, recombinant Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities, the use is not recommended.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk summary: There are no data available on the use of this vaccine in pregnant women to inform of a vaccine-related risk.

Comment:
- This vaccine is not approved for individuals less than 50 years of age.

An animal developmental toxicity study in female rabbits showed no adverse effects on female fertility or preweaning development up to post-natal Day 35, when 0.5 mL were administered by intramuscular injection 28 and 14 days prior to mating, on gestational Day 3, 9, 16, and 24, and on lactation Day 7. 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.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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 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.

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Rsv vaccine pref3, recombinant Breastfeeding Warnings

Safety has not been established.
-According to some authorities, the use is not recommended.

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

-Some experts state that use is not recommended.
-This vaccine is not approved for use in persons less than 50 years of age.
-The effects of the vaccine in the nursing infant and on milk production are unknown.

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

Further information

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