Clinical Evidence Supporting EU Authorisation

The Marketing Authorisation of BioNet’s pertussis-only vaccine is supported by a comprehensive clinical development programme reviewed by the Committee for Medicinal Products for Human Use (CHMP). The assessment included data from three main randomised controlled clinical trials, together with additional supportive studies conducted in relevant populations.

The clinical studies evaluated immunogenicity and safety in adolescents aged 12 years and older, adults, and pregnant women. Across the programme, the pertussis-only vaccine consistently induced robust immune responses directed against pertussis toxin. Neutralising antibody responses were observed across all evaluated age groups and were maintained over time following booster vaccination.

Safety data collected throughout the clinical programme demonstrated that the vaccine was generally well tolerated. The overall evidence package provided a strong basis for regulatory evaluation and supported the conclusion that BioNet’s pertussis-only vaccine meets EU requirements for booster immunisation against pertussis.

Read the full news: VacPertagen Receives EU Approval