Review of prescribing information for influenza vaccines for pregnant and lactating women

Vaccine. 2016 Oct 26;34(45):5406-5409. doi: 10.1016/j.vaccine.2016.08.042. Epub 2016 Aug 29.


Information provided by most influenza vaccine manufacturers do not reflect the recommendations of WHO and/or national public health advisory groups with regard to the use of influenza vaccines in pregnant or lactating women. The majority of vaccines contain precautionary language which could discourage use in pregnant women and some include stronger language discouraging or contradicting use in pregnant or lactating women. Regulators and manufacturers should regularly assess the language of pregnancy and lactation sections in product information for vaccines and include information from national public health advisory groups regarding use by pregnant or lactating women and data from relevant studies.

Keywords: Influenza vaccine; Lactation; Pregnancy; Vaccine safety.

Publication types

  • Review

MeSH terms

  • Breast Feeding*
  • Centers for Disease Control and Prevention, U.S.
  • Consumer Product Safety / standards*
  • Female
  • Humans
  • Influenza Vaccines / adverse effects*
  • Influenza, Human / prevention & control*
  • Lactation*
  • Pregnancy
  • Pregnancy Complications, Infectious / prevention & control*
  • Pregnant Women / psychology*
  • Product Labeling / standards*
  • United States
  • United States Food and Drug Administration
  • Vaccination / standards
  • World Health Organization


  • Influenza Vaccines