BioNet receives positive EMA opinion on new pertussis vaccine
Esme Needham | November 19, 2025 | News story | Research and Development | BioNet, Vaccine
BioNet has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) regarding a new pertussis vaccine.
The positive opinion recommends the granting of a marketing authorisation in the EU for VacPertagen, a stand-alone acellular vaccine for pertussis. The EMA’s decision followed three clinical studies, which demonstrated the benefits on VacPertagen in adults, adolescents and pregnant women.
Pertussis, also known as whooping cough, is a respiratory disease characterised by cold-like symptoms and severe, prolonged coughing fits. It poses a significant danger to newborns and older adults, and has recently seen a resurgence of cases across Europe. Pertussis is preventable through the use of vaccines, and the World Health Organization has recommended routine vaccination against pertussis for children and pregnant women.
VacPertagen has demonstrated long-lasting pertussis antibody persistence in adolescents and adults and is the world’s only available monovalent acellular pertussis vaccine containing two components. It is a non-combined vaccine targeted at the treatment of pertussis only, which BioNet says aligns with current pertussis vaccination guidance and avoids the administration of unnecessary antigens to patients.
Stanley Plotkin, chairman of the BioNet Scientific Advisory Board, said: “Receiving a positive CHMP opinion for VacPertagen reflects years of scientific innovation and clinical development with collaborative efforts across continents. A pertussis-only vaccine is particularly valuable for use during pregnancy in countries where pertussis maternal immunisation programs are recommended for pregnant women who are up-to-date with their diphtheria and tetanus immunisations.”
Philippe Guillot-Chêne, CEO of BioNet Europe, said: “This marks a historic milestone for BioNet and validates our vision to develop an improved pertussis-only vaccine specifically designed to address the re-emergence of pertussis globally.”
BioNet is a developer and manufacturer of vaccines. It operates across 25 countries, and has been producing recombinant pertussis-containing vaccines for the last ten years.
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