Bavarian Nordic Launches COVID-19 Booster Study To Compare Against Pfizer/BioNTech Shot
As Bavarian Nordic A/S (OTC: BVNRY) was in the headlines recently due to the smallpox vaccine amid rising cases of monkeypox, the company is also getting ready to evaluate its COVID-19 booster, ABNCoV2, in a pivotal study.
ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac, Denmark using their proprietary capsid virus-like particle technology.
The upcoming Phase 3 trial will include Pfizer Inc (NYSE: PFE) / BioNTech SE's (NASDAQ: BNTX) COVID-19 shot in the comparator arm.
Also Read: EU, Bavarian Nordic Ink Supply Pact For 110,000 Monkeypox Vaccines.
The company has chosen Comirnaty to potentially support the study's primary objective and demonstrate that the neutralizing antibodies induced by ABNCoV2 are non-inferior to the licensed mRNA-based vaccine.
The Phase 3 trial will enroll approximately 4,000 participants who either previously completed primary vaccination or have already received one booster dose of a licensed COVID-19 vaccine.
The trial consists of two groups, which will run in parallel. The active, controlled group will enroll 1,000 subjects who will be randomized to receive either a single 100 µg dose of ABNCoV2 or a single 30 µg adult booster dose of Comirnaty.
The other group will evaluate the safety and tolerability of the vaccine in 3,000 subjects who will receive a single 100 µg dose of ABNCoV2.
The Phase 3 trial will start enrolling in August 2022. The company anticipates the initial data read-out before the end of 2022, which will allow for a rolling submission to the regulatory authorities, aiming to obtain approval of the vaccine in 2023.
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