MEDIMMUNE LLC LIVE NASAL VACCINE PRODUCT:
8.1 Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist should be given to a pregnant woman only if clearly needed.
The effect of FluMist on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rats receiving the frozen formulation. Groups of animals were administered FluMist either once (during the period of organogenesis on gestation day 6) or twice (prior to gestation and during the period of organogenesis on gestation day 6), 250 microliter/rat/occasion (approximately 110-140 human dose equivalents), by intranasal instillation. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no FluMist related fetal malformations or other evidence of teratogenesis noted in this study.
8.3 Nursing Mothers
It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist is excreted in human milk. Therefore, as some viruses are excreted in human milk and additionally, because of the possibility of shedding of vaccine virus and the close proximity of a nursing infant and mother, caution should be exercised if Influenza A
090910_clean Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal_USPI_submitted [ID0901014]+FDA5 Page 11 of 21
(H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist is administered to nursing mothers.
8.4 Pediatric Use
Safety and effectiveness of FluMist has been demonstrated for children 2 years of age and older with reduction in culture-confirmed influenza rates compared to active control (injectable influenza vaccine made by Sanofi Pasteur Inc.) and placebo [see Clinical Studies (14.1)]. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in children <24 months of age. FluMist use in children <24 months has been associated with increased risk of hospitalization and wheezing in clinical trials [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
SEE ENTIRE FDA REPORT HERE
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf
