pertagen Use In Pregnancy & Lactation

Pregnancy: Maternal immunization can protect newborns and young infants who bear the brunt pertussis mortality (WHO Immunological Basis for Immunization Series, Module 4 Pertussis, 2017). In the USA, moderate to severe local reactions have been associated with high levels of tetanus and diphtheria antitoxin when tetanus toxoid was administered with a reduced amount of diphtheria toxoid. However, because of the potential benefits of maternal pertussis immunization and the lack of monovalent acellular pertussis vaccine in the USA, the Advisory Committee on Immunization Practices (ACIP) recommends that pregnant women receive Tdap boosters during each pregnancy (WHO Global Advisory Committee on Vaccine Safety, 2014).
The previous WHO consideration supports the potential use of Pertagen, a monovalent acellular pertussis vaccine, for maternal pertussis immunization.
In accordance with 2019 WHO recommendations for routine immunization of pertussis-containing vaccine, the use of Pertagen may be considered in the second or third trimester and preferably at least 15 days before the end of pregnancy.
Safety data from active post-marketing surveillance (including a prospective observational study) where 964 pregnant women were exposed to Pertagen (monovalent aP vaccine) or to the aP vaccine of Pertagen combined with tetanus toxoid and reduced diphtheria toxoid (TdaP vaccine, Boostagen) in the second or third trimester of pregnancy have 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 in one animal toxicity study evaluating Pertagen antigens combined to tetanus and diphtheria toxoids. Data in humans from randomized controlled trials on the use of Boostagen (TdaP vaccine containing Pertagen antigens combined to tetanus and diphtheria toxoids) during the second or third trimester of pregnancy are not yet available. While vaccination with Pertagen is not expected to be associated with any increased risk to the foetus as the vaccine is inactivated, Pertagen should only be used during pregnancy when the possible advantages outweigh the possible risks for the foetus.
Lactation: The effect of Pertagen during lactation has not been assessed in humans. While no risk to the breastfed infant should be expected as the vaccine is inactivated, Pertagen should only be used during breastfeeding when the possible advantages of vaccination outweigh the potential risks.