BioNet, a biotechnology company developing and manufacturing next generation vaccines including recombinant and mRNA vaccines, announced on Tuesday that it has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the granting of marketing authorisation in the European Union for VacPertagen, a standalone acellular pertussis vaccine.
The benefits of VacPertagen were demonstrated in three clinical studies in adults, adolescents and pregnant women.
Pertussis is a highly contagious respiratory disease that poses a significant risk to newborns and older adults.
Prof. Emeritus 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."
Philippe Guillot-Chene, CEO of BioNet Europe, added: "This is the first standalone pertussis vaccine to receive a CHMP favourable opinion through the centralised procedure in the European Union. 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."
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BioNet receives positive opinion from EMA for VacPertagen marketing authorisation in EU