Bavarian Nordic initiates Phase II of the clinical development of MVA-BN as a safe smallpox vaccine
This announcement follows the completion of Bavarian Nordic's Phase I clinical trial that is the only study evaluating safe smallpox vaccines to be completed worldwide. The Phase I clinical trial evaluated the safety of various doses of MVA-BN in a total of 86 healthy volunteers and has generated extremely encouraging results demonstrating the great potential of MVA-BN as a safe smallpox vaccine. The highest dose of MVA-BN was well tolerated with no reports of any serious adverse events. Importantly, at this dose MVA-BN was also shown to induce high levels of immunity (antibody and cellular immune response) in 100% of individuals who had previously not been vaccinated against smallpox. Moreover, MVA-BN was also well tolerated and significantly boosted the immune responses (antibody and cellular immune response) in people that had previously been vaccinated against smallpox many years before.
Bavarian Nordic is now the only company to have already completed small animal studies and a clinical Phase I trial, demonstrating the excellent safety and immunogenicity of MVA-BN and the superiority over other MVA strains. In addition, Bavarian Nordic is the only company who has already produced and supplied commercial quantities of MVA. Peter Wulff, President and CEO of Bavarian Nordic: "Bavarian Nordic is now taking a huge step in the clinical development and licensure of MVA-BN by entering clinical Phase II studies. This achievement makes us the leading company developing a safe smallpox vaccine".
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