Boostagen-2 Use In Pregnancy & Lactation

Pregnancy: As per 2019 WHO recommendations for routine immunization of pertussis-containing vaccine, the use of Boostagen-2 may be considered in the second or third trimester and preferably at least 15 days before the end of pregnancy.
Safety data from a randomized controlled trial of one dose of Boostagen-2 administered to pregnant women in the second or third trimester of pregnancy have shown a safety profile in mothers and foetus/newborns similar to the chemically-detoxified pertussis toxin (Tdap_chem) comparator vaccine. In addition, an active post-marketing surveillance (including a prospective observational study) where 1,069 pregnant women were exposed to Boostagen (similar to Boostagen-2 but with a higher amount of PT_gen) in the second or third trimester of pregnancy have also shown no vaccine related adverse effect on pregnancy or the health of newborns.
No adverse effects on pregnancy, parturition, lactation or prenatal and postnatal development were observed after administration of Boostagen in two reproductive and developmental animal toxicity studies.
Lactation: As Boostagen-2 contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. No study on lactation was performed in humans.