Vaxigrip Use In Pregnancy & Lactation

Pregnancy: Pregnant women are at high risk of influenza complications, including premature labour and delivery, hospitalization, and death: pregnant women should receive an influenza vaccine.
Vaxigrip can be used in all stages of pregnancy.
Larger datasets on safety of inactivated influenza vaccines are available for the second and third trimesters than for with the first trimester. Data from worldwide use of inactivated influenza vaccines, including Vaxigrip and Quadrivalent Influenza Vaccine (split virion, inactivated), do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.
This is consistent with results observed in one clinical study where Vaxigrip and Quadrivalent Influenza Vaccine (split virion, inactivated) were administered in pregnant women during the second or third trimester (116 exposed pregnancies and 119 live births for Vaxigrip, 230 exposed pregnancies and 231 live births for Quadrivalent Influenza Vaccine (split virion, inactivated)).
Data from four clinical studies with Vaxigrip administered in pregnant women during the second or third trimester (more than 5,000 exposed pregnancies and more than 5,000 live births followed up to approximately 6 months post-partum) did not indicate any adverse foetal, newborn, infant and maternal outcomes attributable to the vaccine.
In clinical studies conducted in South Africa and Nepal, there were no significant differences between the Vaxigrip and placebo groups with regards to foetal, newborn, infant and maternal outcomes (including miscarriage, stillbirth, premature birth, low birth weight).
In a study conducted in Mali, there were no significant differences between the Vaxigrip and control vaccine (quadrivalent meningococcal conjugate vaccine) groups with regards to prematurity rate, stillbirth rate and low birth weight/small for gestational age rate.
For additional information, see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions.
Results of one reproductive study in rabbits conducted with Quadrivalent Influenza Vaccine (split virion, inactivated) (60 µg of total amount HA/dose) can be extrapolated to Vaxigrip (45 µg of total amount HA/dose): this study did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal development.
Breast-feeding: Vaxigrip may be used during breast-feeding.
Fertility: No fertility data are available in Humans. One animal study with Quadrivalent Influenza Vaccine (split virion, inactivated) did not indicate harmful effects on female fertility.