Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and 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 Tetra 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 the first trimester. Data from worldwide use of inactivated influenza vaccines, including Vaxigrip Tetra and Inactivated Influenza Vaccine (Split Virion) BP (trivalent inactivated influenza vaccine), do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.
This is consistent with results observed in one clinical study where Quadrivalent Influenza Vaccine (split virion, inactivated) and Inactivated Influenza Vaccine (Split Virion) BP were administered in pregnant women during the second or third trimester (230 exposed pregnancies and 231 live births for Quadrivalent Influenza Vaccine (split virion, inactivated) and 116 exposed pregnancies and 119 live births for Inactivated Influenza Vaccine (Split Virion) BP).
Data from four clinical studies with the trivalent inactivated influenza vaccine (Inactivated Influenza Vaccine (Split Virion) BP thiomersal-free formulation) 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 Inactivated Influenza Vaccine (Split Virion) BP 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 Inactivated Influenza Vaccine (Split Virion) BP 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 Sections 4.8 and 5.1.
One animal study with Vaxigrip Tetra did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal development.
Breastfeeding
Vaxigrip Tetra may be used during breastfeeding.
Fertility
There are no fertility data available in Humans. One animal study with Vaxigrip Tetra did not indicate harmful effects on female fertility.