Measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine Pregnancy and Breastfeeding Warnings

Brand names: ProQuad

Medically reviewed by Drugs.com. Last updated on Sep 5, 2023.

Measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: B2
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.

Comments:
-Test women of childbearing age for rubella antibodies prior to pregnancy. Offer rubella vaccine to all non-pregnant seronegative women.
-Advice women who intend to become pregnant to delay pregnancy.
-It is recommended to avoid pregnancy for 3 months after vaccination.
-A pregnancy exposure registry is available.

Animal studies have not been reported. It is unknown whether this vaccine can cause fetal harm or affect reproduction capacity. Currently available live virus vaccines have not caused teratogenic effects in humans. Use caution as live virus vaccines have been shown to cross the placenta and infect the fetus. There are no controlled data in human pregnancy.

Contracting wild-type measles during pregnancy increased the rates of spontaneous abortion, stillbirth, congenital defects, and prematurity. There are no adequate studies of the vaccine strain of measle virus in pregnancy. However, it is prudent to assume that the vaccine strain is capable of inducing adverse fetal effects.

Mumps infection during the first trimester may increase the rate of spontaneous abortion. Although mumps vaccine virus can infect the placenta and fetus, there is no evidence that it causes congenital malformations in humans.

In a 15-year survey of over 1100 women who received rubella vaccine within 3 months before or after conception (of whom 635 received the Wistar RA 27/3 strain), none of the newborns had rubella-like birth defects.

Wild-type varicella can cause congenital varicella infection. A pregnancy registry maintained from 1995 to 2013 tracked over 800 women who received varicella-containing vaccines within 3 months prior to or during pregnancy. None of the infants had abnormalities consistent with varicella syndrome.

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 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

Measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine Breastfeeding Warnings

Benefit to mother should outweigh risk to the infant.
-According to some authorities: Caution is recommended.

Excreted into human milk:
-Varicella, measles, or mumps vaccine virus: Unknown
-Rubella vaccine virus: Yes
Excreted into animal milk: Data not available

Comments:
-Transmission of the rubella vaccine virus to infants via breast milk has been reported.
-The U.S. Centers for Disease Control and Prevention (CDC) consider the administration of live virus vaccines compatible with breast-feeding.

See references

Further information

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