BioNet, a biotechnology company dedicated to innovative vaccines, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion under the centralised procedure recommending marketing authorisation for VacPertagen for booster immunisation in individuals 12 years onwards and passive immunisation during pregnancy.
Prof. Emeritus Stanley Plotkin, Chairman of BioNet's Scientific Advisory Board and an eminent expert in vaccinology, stated: "Receiving a positive CHMP opinion for VacPertagen reflects years of scientific innovation and clinical development through collaborative efforts across continents."
"A pertussis-only vaccine is particularly valuable for use during pregnancy in countries where maternal immunisation programs are recommended for women who are already up to date with their diphtheria and tetanus immunisations. He added."
Vitoon Vonghangool, President, BioNet Asia, 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. Pertussis is a highly contagious respiratory disease that poses a significant risk to newborns and older adults."
"This is the first standalone pertussis vaccine to receive a CHMP favourable opinion through the centralised procedure in the European Union," said Philippe Guillot-Chene, CEO, BioNet Europe. "The recent resurgence of pertussis cases across Europe underscores the urgent need to strengthen prevention through maternal immunisation and booster vaccination programs."
About VacPertagen / Pertagen(R)
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 and for booster use in adults, elderly and travellers. Immunisation in adolescents and adults demonstrated long-lasting antibody persistence against pertussis.
The vaccine is marketed under the trademark Pertagen(R) in Asia
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. BioNet recently achieved EU-GMP certification for its pertussis vaccine manufacturing facility, following inspection and approval by the Health Products Regulatory Authority (HPRA) of Ireland.
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