Positive results released from two pivotal clinical smallpox vaccine studies
The Phase 3 study was double-blind, randomized, and placebo-controlled, the gold standard for scientific studies. Four thousand vaccinia-naïve subjects participated in the study. There were no serious side effects to the vaccinations.
The Phase 2 study was designed to compare and contrast the results of the freeze-dried vaccine with the liquid vaccine to determine whether they had similar safety and immunogenicity. Six hundred and fifty vaccinia-naïve health participants were randomly administered either a liquid or freeze-dried vaccine. Thanks to the positive results, the US Strategic National Stockpile will now begin to stockpile freeze-dried IMVAMUNE.
"Completing this pivotal Phase 2 study is a significant step in the transition to the freeze-dried version of the vaccine, which provides a number of advantages for future procurement and stockpiling, thereby broadening the commercial potential,” Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said. “We remain on track to complete the transfer of the manufacturing process which will enable us to start deliveries in 2016, as we look forward to continuing our successful long-standing collaboration with the U.S. Government on their public health preparedness."