- As Bavarian Nordic A/S 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 PFE / BioNTech SE's 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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