Influenza virus vaccine, inactivated Pregnancy and Breastfeeding Warnings

Brand names: Afluria, Afluria Quadrivalent, FluLaval, FluLaval Preservative-Free Quadrivalent, FluLaval Quadrivalent, Fluad, Fluad Quadrivalent, Fluarix, Fluarix Quadrivalent, Flublok, Flublok Quadrivalent, Flucelvax, Flucelvax Quadrivalent, Fluogen, Fluvirin, Fluvirin Preservative-Free, Fluzone, Fluzone High-Dose, Fluzone High-Dose Quadrivalent, Fluzone Intradermal, Fluzone Intradermal Quadrivalent, Fluzone Preservative-Free, Fluzone Preservative-Free Pediatric, Fluzone Preservative-Free Pediatric Quadrivalent, Fluzone Quadrivalent

Medically reviewed by Drugs.com. Last updated on Aug 2, 2023.

Influenza virus vaccine, inactivated Pregnancy Warnings

According to some authorities: Use is recommended if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: A or B2, depending on vaccine formulation
US FDA pregnancy category: Not assigned

Risk summary: There are limited data on the use of influenza vaccines in pregnant women to inform a vaccine-associated risk.

Comments:
-Consult the manufacturer product information for specific pregnancy categories.
-Data from various prospective pregnancy registries in the US and clinical studies worldwide did not demonstrate evidence of a vaccine-associated increase in the risk of major birth defects or miscarriages.
-According to some authorities: Influenza vaccination is recommended for pregnant women during any stage of pregnancy, particularly those who will be in the second or third trimester during the influenza season.
-There are risks to the mother and fetus associated with influenza disease during pregnancy
-A pregnancy exposure registry is available.

Animal studies have not revealed evidence of direct or indirect harmful effects with respect to pregnancy, embryo-fetal development, or early post-natal development. When inactivated influenza virus vaccines were administered to animals prior to mating, during organogenesis, and late pregnancy, there were no vaccine-related fetal malformations/variations or adverse pre-weaning developmental effects. There are no controlled data in human pregnancy. However, inactivated influenza virus vaccines have been evaluated in more than 80,000 pregnant women worldwide and the collected data do not indicate any adverse fetal and maternal outcomes attributable to the vaccine.

Pregnant women infected with seasonal influenza are at increased risk of severe illness associated with influenza infection compared to non-pregnant women. In addition, pregnant women are at high risk of influenza complications, including premature labor and delivery, hospitalization, and death.

To monitor the outcomes of pregnant women exposed to Fluzone Quadrivalent and Flublok Quadrivalent, a pregnancy registry has been established by Sanofi Pasteur, Inc. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by visiting: https://www.sanofipasteurpregnancyregistry.com/

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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

Influenza virus vaccine, inactivated Breastfeeding Warnings

Use is generally considered acceptable; benefit should outweigh risk.

Excreted into human milk: No

Comments:
-The US CDC and several health professional organizations state that vaccines given to a nursing mother do not affect the safety of breastfeeding for mothers or infants and that breastfeeding is not a contraindication to the inactivated (injected) influenza vaccine.
-Vaccination of the mother increases influenza antibodies and influenza-specific CD8 T-cells in breastmilk, which may offer added protection to the breastfed infant against influenza.
-Limited data indicate that breastfeeding can enhance the response of the infant to certain vaccine antigens.
-According to some experts, no vaccine or wild-type influenza virus was detected in the breastmilk of lactating women after administration of inactivated (or live) influenza vaccine.
-Based on limited studies, effects in infants included a reduction in episodes of respiratory illness.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug, as well as any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition (i.e., susceptibility to influenza).

See references

Further information

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

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