Vaccines 2025

VacPertagen (BioNet) is a next generation pertussis vaccine designed to overcome the immunological shortcomings of current acellular formulations. The platform integrates two refined recombinant antigens: pertussis toxin (PTgen) and filamentous haemagglutinin (FHA). Both antigens are produced through precision molecular engineering. The genes encoding PT and FHA are cloned into high yield expression systems, typically using plasmid vectors introduced into cultured production cells. These cells express the proteins in a controlled environment that allows accurate folding, stabilization of key conformational epitopes, and removal of reactogenic elements. The recombinant proteins are then purified with chromatographic methods that isolate structurally intact antigenic domains while eliminating residual cellular material. This process ensures reproducible antigen quality, consistent molecular composition, and enhanced presentation of the immunologically relevant epitopes. Antigen delivery is further optimized through a nanoparticle based formulation that stabilizes the recombinant proteins and promotes efficient uptake by antigen presenting cells. The vaccine has received marketing authorization in Japan and Australia, and on November 14, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion supporting VacPertagen as a pertussis booster in individuals twelve years of age or older and for passive protection of infants when administered during pregnancy. Current acellular pertussis vaccines contain purified components such as pertussis toxin, filamentous hemagglutinin, pertactin, and fimbrial antigens. These formulations significantly reduced reactogenicity compared with historical whole cell vaccines but induce immunity that wanes within a few years. VacPertagen was developed to address this limitation by combining purified recombinant antigens with a more immunologically efficient delivery platform.