VaxigripTetra NH/VaxigripTetra SH Use In Pregnancy & Lactation

Pregnancy: Data from four clinical studies conducted with Vaxigrip (trivalent influenza vaccine, TIV) administered to pregnant women during the second and third trimesters (more than 5,000 exposed pregnancies and more than 5,000 live births, followed up to approximately 6 months postpartum) did not indicate any adverse fetal, newborn, infant, or maternal outcomes attributable to the vaccine.
In three of these clinical studies conducted in South Africa and Nepal, there were no significant differences between the Vaxigrip (TIV) and placebo groups with regards to fetal, newborn, infant, or maternal outcomes (including miscarriage, stillbirth, premature birth, low birth weight).
In the fourth study conducted in Mali, there were no significant differences between the Vaxigrip (TIV) and control vaccine (quadrivalent meningococcal conjugate vaccine) groups with regards to prematurity rate, stillbirth rate, or rate of low birth weight/small for gestational age.
Data from a clinical study conducted in Finland with VaxigripTetra NH/VaxigripTetra SH administered in pregnant women during the second or third trimester (230 exposed pregnancies and 231 live births) did not indicate any adverse fetal or maternal outcomes attributable to the vaccine.
VaxigripTetra NH/VaxigripTetra SH can be administered in all stages of pregnancy based on the safety data from clinical studies and post-marketing experience. Because of the known adverse consequences of influenza infection in pregnant women, health authorities recommend vaccination of pregnant women.
One animal study with VaxigripTetra NH/VaxigripTetra SH did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal development.
Breastfeeding: There are no data on the use of VaxigripTetra NH/VaxigripTetra SH in breastfeeding women.
Based on experience with inactivated influenza vaccines, VaxigripTetra NH/VaxigripTetra SH may be used during breastfeeding.
Fertility: There are no fertility data available in Humans. One animal study with VaxigripTetra NH/VaxigripTetra SH did not indicate harmful effects on female fertility.