Bavarian Nordic Reports Omicron Data from Phase 2 Trial of its COVID-19 Booster … – Press Release

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COPENHAGEN, Denmark, May 5, 2022 – Bavarian Nordic A/S BAVA announced today additional results from its Phase 2 clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 vaccine candidate. Data from subjects, who were previously vaccinated with approved mRNA or adenoviral vaccines, demonstrated that vaccination with ABNCoV2 induced a significant boost to the neutralizing antibodies against the Omicron variant in the majority of subjects with a fold increase in the same range as previously reported for the original Wuhan SARS-CoV2 variant. While the neutralizing antibody titers against Omicron were the lowest when compared to all other variants previously reported (Wuhan, Alpha, Beta and Delta) they were boosted to levels associated with a high level of protection1 across both dose groups, 50μg and 100μg.

These data follow the announcement of topline results from the Phase 2 trial in December 2021 and February 2022, demonstrating that a single vaccination with 50μg or 100μg ABNCoV2 can boost neutralizing antibodies to levels reported to be highly efficacious (>90%) against SARS-CoV21, irrespective of type of vaccine previously received (mRNA or adenovirus-based), or the initial level of neutralizing antibody titers before booster vaccination with ABNCoV2.

Paul Chaplin, President and CEO of Bavarian Nordic, commented: “We now have demonstrated a large range of immune responses against different variants of concern, including Omicron. This encourages us to continue to rapidly initiate our phase 3 study and subsequently submit this vaccine for licensure.”

Supported by the Danish State, Bavarian Nordic plans to initiate soon a Phase 3 program of ABNCoV2. The program will include approximately 4,000 seropositive subjects who will receive a booster vaccination with 100 μg ABNCoV2 or an mRNA-based vaccine, aiming to demonstrate non-inferiority of ABNCoV2 to the licensed mRNA vaccine.

About ABNCoV2
ABNCoV2 is a next-generation COVID-19 vaccine candidate,…

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