CHMP adopts a positive opinion for VacPertagen, a pertussis vaccine – BioNet

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for VacPertagen, a vaccine intended for prophylaxis against pertussis. The applicant  is BioNet Europe. VacPertagen will be available as a suspension for injection in pre-filled syringes. The active substances in VacPertagen are two purified pertussis antigens: recombinant pertussis toxin (PT_gen) and filamentous haemagglutinin (FHA). Following intramuscular administration of a single dose, VacPertagen induces a boost in PT-specific and FHA-specific antibody responses. Maternal antibodies are transferred to infants born to women vaccinated during the second or third trimester of pregnancy.

The benefits of VacPertagen were shown in 3 clinical studies, which found that VacPertagen triggered the production of antibodies at 28 days after vaccination in adults and adolescents, with antibodies persisting for up to 3 years in adults and 5 years in adolescents. It also induced an immune response in pregnant women 28 days after vaccination during the second or third trimester of pregnancy. In addition, the pertussis antibodies were transferred from mothers to infants at birth and persisted for up to 2 months of age. The most common side effects with VacPertagen include pain at the injection site, headache, fatigue, myalgia, arthralgia, malaise and nausea.