Influenza immunization during pregnancy: US regulatory perspective.
Maternal immunization with inactivated influenza vaccines is an important public health strategy to protect mothers and young infants from the serious complications of influenza. Although not contraindicated in pregnant women, currently US-licensed influenza vaccines are not specifically labeled for use during pregnancy. Several postmarketing initiatives are ongoing to obtain maternal and infant safety and immunogenicity data on US-licensed inactivated influenza vaccines used in pregnant women. The Food and Drug Administration is revising its pregnancy labeling regulations to improve the characterization and communication of risks of drugs and biologics used during pregnancy. To obtain a specifically labeled indication for use of an influenza vaccine during pregnancy, adequate and well-controlled prelicensure studies are needed to obtain data on the product's safety and effectiveness and to demonstrate protection of the mother and/or infant against influenza illness.
Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA.
Valerie
V
Marshall
Marion
M
Gruber
D002986:Clinical Trials as Topic; D005260:Female; D033161:Government Regulation; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D007251:Influenza, Human / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D011295:Prenatal Care; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration; D014611:Vaccination / Q000331:legislation & jurisprudence; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects
D007252:Influenza Vaccines; D015164:Vaccines, Inactivated