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BioNet-Asia, a vaccine company focused on technological innovation and market access, announced that its first recombinant acellular Pertussis booster vaccine containing a proprietary genetically-detoxified Pertussis Toxin (PTgen), received Marketing Authorization Approval (MAA) from the Thai Food and Drug Administration.
The vaccine is indicated in individuals from the age of 11 years onwards for active booster immunization against pertussis, a highly contagious respiratory infection caused by Bordetella pertussis. There are 16 million pertussis cases worldwide each year.
Dr Jean Petre, chief scientific officer and co-founder of BioNet said: "The approval of this innovative vaccine is the fruit of ten years of research on a new generation of recombinant pertussis vaccines to overcome the limitation of conventional acellular vaccines. BioNet's recombinant DNA technology allows the production of a genetically-detoxified Pertussis Toxin (PTgen) without altering the structure of the epitopes of the Pertussis Toxin (PT). Therefore, induced antibodies can better recognize PT epitopes which results in an increased immune response to PT, as successfully demonstrated with PTgen-containing vaccines in comparative clinical studies."
In a clinical trial, 95% of adolescents immunized with BioNet's aP vaccine seroconverted to PT (4-fold increase of antibody titer) compared to 55% vaccinated with a leading marketed Tdap vaccine. BioNet's recombinant vaccine also induced significantly higher anti-PT neutralizing antibody titers.
"With the pertussis disease re-emerging in many countries, the medical community is advocating for pertussis control strategies and the improvement of current vaccines. Conventional Tdap vaccines provide durable protection against diphtheria and tetanus but induce short-lived pertussis immunity," indicated Professor Stanley Plotkin, chairman of BioNet's Scientific Advisory Board.
"The availability of such a recombinant pertussis vaccine that induce higher initial antibody levels can address an unmet medical need. Having now a monovalent acellular pertussis vaccine can provide the healthcare professionals and policy makers with a new way to approach pertussis immunization, when only boosting pertussis immunity is sought, as for example in pregnant women to protect their newborns."
BioNet's vaccine may be considered as an alternative to combined tetanus, diphtheria and acellular pertussis vaccines in persons having received multiple and frequent tetanus and diphtheria vaccine doses.
Jacques-Francois Martin, chairman of BioNet's Strategic Advisory Board, added: "This MAA paves the way for further registration in other countries, especially where there is a resurgence of pertussis. New clinical studies in Europe and Asia-Pacific are ongoing or under planning to further evaluate BioNet's monovalent vaccine but also other formulations of PTgen-containing vaccines."
In the recent years, Pertussis has been resurgent in many countries and it is a major public health concern in USA, UK and Australia.
Bionet gets thai fda marketing authorization approval for recombinant monovalent acellular pertussis vaccine
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