Press release
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• • BAVARIAN NORDIC REPORTS POSITIVE RESULTS FROM HUMAN CHALLENGE TRIAL OF ITS RSV VACCINE CANDIDATE Study achieved the primary endpoint by demonstrating a statistically significant reduction in viral load in vaccinated versus control ( placebo ) treated volunteers Demonstrated up to a 79 % efficacy in reducing symptomatic RSV infections Management will host a conference call today at 2 pm CET ( 8 am EST ) to review the results COPENHAGEN , Denmark , September 1 , 2021 - Bavarian Nordic A / S ( OMX : BAVA ) announced today results from a human challenge trial of the RSV vaccine candidate , MVA - BNⓇ RSV . The phase 2 double - blinded , placebo- controlled trial enrolled healthy adult volunteers , 18-50 years of age who were randomized to receive either a single vaccination of MVA - BN RSV or placebo . Volunteers were challenged intranasally with an RSV type A strain 28 days after vaccination . A total of 61 subjects were evaluable . The study demonstrated a significant reduction in viral load in vaccinated subjects ( n = 30 ) versus placebo ( n = 31 ) , thus meeting the primary endpoint of this pivotal study . At the same time , the vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections . The MVA - BN RSV vaccine demonstrated a vaccine efficacy of up to 79 % in preventing symptomatic RSV infections . No vaccine - related serious adverse events were observed , and the vaccine was well tolerated , consistent with the safety profile previously reported in phase 1 and phase 2 clinical studies . Paul Chaplin , President and CEO of Bavarian Nordic , commented : " We are pleased to report these highly encouraging results , that are equivalent to , or even better than those of competitor candidates and which confirm the potential of our RSV vaccine candidate . MVA - BN RSV has been designed to simulate a broad immune response against RSV by incorporating not only one , but five different antigens of the virus , thereby offering the advantage of a broad protection against RSV that will likely be required to prevent hospitalization with severe disease caused by RSV . The COVID - 19 pandemic has clearly demonstrated the susceptibility and severity of respiratory viruses in vulnerable populations , and we remain committed to bring this novel vaccine to the market to fulfil the high unmet medical need in the elderly population , which is estimated to be on par with influenza . " Pending further analysis of the current RSV infection rates , discussions with regulatory authorities about the Phase 3 design , and funding / partnering considerations , the Company will determine the immediate next steps and expects to communicate these during fourth quarter of 2021 . Conference call and webcast The management of Bavarian Nordic will host a conference call today at 2 pm CET ( 8 am EST ) to review the trial results followed by a Q & A session . A listen - only version of the call can be accessed via . To join the Q & A session , use one of the following dial - in numbers : Denmark : +45 32 72 04 17 , UK : +44 ( 0 ) 844 481 9752 , USA : +1 646-741-3167 . Participant code is 7370558 . About Respiratory Syncytial Virus ( RSV ) RSV is a common virus that usually causes mild , cold - like symptoms , but in serious cases can cause severe lung infections , including bronchiolitis and pneumonia . Those at risk are typically young infants and the elderly as