Press release
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• • • BAVARIAN NORDIC REPORTS POSITIVE TOPLINE PHASE 2 RESULTS FOR ITS COVID - 19 VACCINE CANDIDATE Bavarian Nordic's non - adjuvanted COVID - 19 vaccine candidate , ABNCOV2 ( 100 µg ) , demonstrated a strong boosting effect , increasing the existing levels of SARS - CoV - 2 neutralizing antibodies against the Wuhan variant by 2-40 - fold depending on the initial levels of antibodies The large boosting effect of ABNCOV2 elevated the neutralizing antibodies to levels reported to be highly efficacious ( > 90 % ) against SARS - COV - 2 A similar fold increase was observed for all SARS - CoV - 2 variants tested ( Wuhan , Alpha , Beta and Delta ) following the booster vaccination with ABNCOV2 • The vaccine was well - tolerated , with no serious adverse events reported • • These initial results confirm the potential of ABNCoV2 to function as a universal COVID - 19 booster vaccine The Company's management will host a conference call tomorrow at 2 pm CET ( 8 am EST ) to discuss the results COPENHAGEN , Denmark , December 5 , 2021 - Bavarian Nordic A / S ( OMX : BAVA ) , a fully integrated vaccines company , announced today positive topline results from a Phase 2 clinical trial of its COVID - 19 vaccine candidate , ABNCOV2 . ABNCOV2 Phase 2 trial results One hundred and three ( 103 ) subjects 18 years and older ( 23 % above 65 years ) that had been previously vaccinated with mRNA ( 67 % ) or adenoviral ( 32 % ) COVID - 19 vaccines were enrolled and received a single booster vaccination with ABNCOV2 ( 100µg ) . At enrolment , the majority ( ≥57 % ) of all subjects either had no detectable neutralizing antibodies and / or were below the levels that could be quantified and the average neutralizing antibody titers against all SARS - CoV - 2 variants tested were at levels reported to provide decreased levels of protection from COVID - 191 . One ( 1 ) week post vaccination with ABNCOV2 , a 2-34 - fold increase in the levels of neutralizing antibodies against the Wuhan SARS - CoV2 variant was observed and peaked at two ( 2 ) weeks with a 2-40 - fold increase depending on the initial antibody levels . However , all subjects , irrespective of whether they initially had very low , or high neutralizing titers were boosted to absolute antibody levels reported to be associated with a very high efficacy ( > 90 % ) against SARS - CoV21 . The same trend in terms of the fold - increases post the booster with ABNCOV2 was also observed for all other SARS - CoV2 variants tested , namely Alpha , Beta and Delta . ABNCOV2 was well tolerated with no serious adverse events reported . The most frequent observations were local injection site reactions that resolved shorty after vaccination . Enrolment continues in the second seropositive group , receiving a single 50µg dose of ABNCOV2 and a seronegative group receiving two 100 µg doses of ABNCOV2 . Paul Chaplin , President and CEO of Bavarian Nordic , commented : “ We are very pleased to report positive top- line results for our COVID - 19 vaccine candidate , confirming the perfect profile as a non - adjuvanted universal booster vaccine . I am encouraged to see that ABNCOV2 boosted the levels of immunity to those associated with a high efficacy against COVID - 19 and this was the case whether there was a low or high initial neutralizing antibody level . These results highlight the urgent need for an improved vaccine providing a more robust and long - lived level of protection " .