Bexsero Use In Pregnancy & Lactation

Fertility: There are no data on fertility in humans.
There were no effects on female fertility in animal studies.
There were no effects on the mating performance or fertility of female rabbits in an embryofoetal and developmental toxicity study in which rabbits were intramuscularly injected with Meningococcal Group B Vaccine (Bexsero) 35, 21, and 7 days prior to mating and on gestation days 7 and 20. Male fertility has not been assessed in animals.
Pregnancy: Insufficient clinical data on exposed pregnancies are available.
The potential risk for pregnant women is unknown. Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
There was no evidence of maternal or foetal toxicity, and no effects on pregnancy, maternal behaviour, female fertility, or postnatal development in a study in which female rabbits received Meningococcal Group B Vaccine (Bexsero) at approximately 10 times the human dose equivalent based on body weights.
Lactation: Information on the safety of the vaccine to women and their children during breast-feeding is not available. The benefit-risk ratio must be examined before making the decision to immunise during breast-feeding.
No adverse reactions were seen in vaccinated maternal rabbits or in their offspring through day 29 of lactation. Meningococcal Group B Vaccine (Bexsero) was immunogenic in maternal animals vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined.