BioNet's VacPertagen Receives Positive EMA Opinion as First Standalone Pertussis Vaccine in EU
Key Insights
BioNet (search) announced that the European Medicines Agency (search)'s CHMP (search) has issued a positive opinion for VacPertagen, marking the first standalone pertussis (search) vaccine to receive favorable recommendation through the EU's centralized procedure.
VacPertagen is the world's only available monovalent acellular pertussis (search) vaccine containing recombinant Pertussis Toxin (search) (PTgen (search)), demonstrated effective in three clinical studies across adults, adolescents, and pregnant women.
The vaccine addresses the recent resurgence of pertussis (search) cases across Europe and provides flexibility for maternal immunization programs by avoiding unnecessary antigens found in combination vaccines.
BioNet (search), a biotechnology company focused on next-generation vaccines, announced that the Committee for Medicinal Products for Human Use (CHMP (search)) of the European Medicines Agency (search) (EMA) has adopted a positive opinion recommending the granting of a marketing authorization in the European Union for VacPertagen, a standalone acellular pertussis (search) vaccine. This represents the first standalone pertussis vaccine to receive a CHMP favorable opinion through the centralized procedure in the European Union.
Clinical Evidence and Development
The benefits of VacPertagen were demonstrated in three clinical studies conducted in adults, adolescents, and pregnant women. The vaccine has shown long-lasting pertussis (search) antibody persistence in adolescents and adults, providing evidence of its potential effectiveness across different age groups.
"Receiving a positive CHMP (search) 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 (search) Scientific Advisory Board and an eminent expert in vaccinology.
Addressing Pertussis Resurgence
Pertussis (search) 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 immunization and booster vaccination programs.
Philippe Guillot-Chêne, CEO of BioNet (search) Europe, emphasized the significance of this milestone: "This marks a historic milestone for BioNet and validates our vision to develop an improved pertussis (search)-only vaccine specifically designed to address the re-emergence of pertussis globally."
Unique Vaccine Characteristics
VacPertagen is the world's only available monovalent acellular pertussis (search) vaccine containing two components, including a recombinant Pertussis Toxin (search) (PTgen (search)). As a non-combined vaccine, VacPertagen aligns with current pertussis vaccination recommendations while avoiding the administration of unnecessary antigens.
The standalone nature of the vaccine provides particular value for use during pregnancy in countries where pertussis (search) maternal immunization programs are recommended for pregnant women who are up-to-date with their diphtheria and tetanus immunizations. This flexibility in maternal immunization strategies addresses a specific clinical need in vaccination programs.
Company Background
BioNet (search) is a pioneering biotechnology group developing and manufacturing next-generation vaccines, including recombinant and mRNA vaccines. The company operates in 25 countries with a direct presence in Europe and Asia-Pacific. For the past 10 years, BioNet has been producing recombinant pertussis (search)-containing vaccines, establishing expertise in this therapeutic area.
The positive CHMP (search) opinion represents a significant regulatory milestone that could lead to the first standalone pertussis (search) vaccine becoming available in the European Union, potentially providing healthcare providers with new options for pertussis prevention strategies.