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European Commission Grants EU Marketing Authorisation for a New Pertussis-Only Vaccine

Pertussis-Only Booster Vaccine Receives EU Marketing Authorisation

For many individuals, protection against pertussis remains important, while booster vaccination against tetanus and diphtheria may not always be required at the same time. BioNet has developed a pertussis-only vaccine that has received Marketing Authorisation in the European Union, providing an option for targeted vaccination against whooping cough without inclusion of additional antigens.

This approach may be relevant for populations who receive pertussis boosters more frequently. Current immunisation recommendations, for example, advise pertussis vaccination during each pregnancy, and certain occupational groups may require periodic boosters due to potential exposure. In such contexts, a pertussis-only vaccination option authorised for use in the EU may support more focused immunisation strategies.

By limiting vaccination to the pertussis antigen, this vaccine is designed to reduce exposure to components that may not be required in specific booster situations and to support flexibility in vaccination scheduling. It may also represent an alternative option for individuals seeking pertussis protection without concomitant vaccination against tetanus and diphtheria, in accordance with clinical guidance and individual medical assessment.

The vaccine’s EU Marketing Authorisation is based on a clinical development programme that includes studies evaluating safety and immunogenicity. Data from these studies demonstrate the induction of neutralising antibody responses against pertussis toxin, with persistence observed over time when compared with licensed acellular pertussis combination booster vaccines.

BioNet’s pertussis-only vaccine reflects an approach aimed at expanding vaccination options within the European Union through targeted antigen selection, while maintaining alignment with established regulatory standards for quality, safety, and clinical evaluation.

Read the full news: VacPertagen Receives EU Approval