BioNet Receives Positive CHMP Opinion from EMA for VacPertagen, a Recombinant Vaccine Against Pertussis
LYON, France, Nov. 18, 2025 /PRNewswire/ -- BioNet, a biotechnology company focused on next-generation vaccines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for VacPertagen, a standalone acellular pertussis vaccine.
The benefits of VacPertagen were shown in 3 clinical studies in adults, adolescents and pregnant women.
Expert perspectives on pertussis prevention
"Receiving a positive CHMP opinion for VacPertagen reflects years of scientific innovation and clinical development with collaborative efforts across continents," said Prof. Emeritus Stanley Plotkin , chairman of the BioNet Scientific Advisory Board and an eminent expert in vaccinology .
"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."
BioNet leadership comments
"This is the first standalone pertussis vaccine to receive a CHMP favourable opinion through the centralised procedure in the European Union," said Philippe Guillot-Chêne, CEO, BioNet Europe.
"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."
About pertussis disease
Pertussis is a highly contagious respiratory disease that poses a significant risk to newborns and older adults. The recent resurgence of pertussis cases across Europe underscores the urgent need to strengthen prevention through maternal immunisation and booster vaccination programs.
About VacPertagen
VacPertagen is the world's only available monovalent acellular pertussis vaccine containing two components including a recombinant Pertussis Toxin (PTgen). As a non-combined vaccine, VacPertagen aligns with current pertussis vaccination recommendations while avoiding the administration of unnecessary antigens. A pertussis only vaccine is indeed relevant for use during pregnancy in countries, where flexibility in maternal immunisation strategies is needed. In adolescents and adults, VacPertagen has demonstrated long-lasting pertussis antibody persistence.
About BioNet
BioNet is a pioneering biotechnology group developing and manufacturing next generation vaccines including recombinant and mRNA vaccines. BioNet is operating in 25 countries with a direct presence in Europe and Asia-Pacific. For the past 10 years, BioNet has been producing recombinant pertussis containing vaccines.
Media contacts:
Benoit Soubeyrand MD, Director Medical Affairs, BioNet Europe
[email protected]
Tel: + 33 (0)744762831
www.bionet.one
More information: [email protected]
www.ema.europa.eu/en/medicines/human/EPAR/vacpertagen
SOURCE BioNet Europe
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