Review of prescribing information for influenza vaccines for pregnant and lactating women.
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.
Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205, USA. Electronic address: tproveau@jhu.edu.
Tina
T
Proveaux
Initiative for Vaccine Research, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland.
Philipp
P
Lambach
Initiative for Vaccine Research, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland.
Justin R
JR
Ortiz
Initiative for Vaccine Research, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland.
Joachim
J
Hombach
Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205, USA.
Neal A
NA
Halsey
D001942:Breast Feeding; D002487:Centers for Disease Control and Prevention, U.S.; D003257:Consumer Product Safety / Q000592:standards*; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control*; D007774:Lactation; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D037841:Pregnant People / Q000523:psychology*; D011356:Product Labeling / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration; D014611:Vaccination / Q000592:standards; D014944:World Health Organization
D007252:Influenza Vaccines
Influenza vaccine; Lactation; Pregnancy; Vaccine safety