BioNet has revealed that the CHMP of the EMA has issued a positive recommendation supporting the approval of VacPertagen, a recombinant acellular pertussis vaccine, for marketing throughout the European Union.
The vaccine’s strengths were demonstrated in three clinical trials conducted with adult groups, adolescent volunteers, 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.
More information: info@bionet.one
