Bavarian Nordic releases results of Phase 3 study for smallpox vaccine

Bavarian Nordic released the results from its Phase 3 study of the freeze-dried formulation of its MVA-BN smallpox vaccine.

The FDA approved the liquid-frozen formulation of the vaccine in September 2019 under the name JYNNEOS. The prior Phase 2 study has shown bioequivalence between the freeze-dried and liquid-frozen formulations.

The Phase 3 study — funded by the Biomedical Advanced Research and Development Authority (BARDA) — was a randomized, double-blind study evaluating the immunogenicity and safety of three consecutive vaccine lots of the freeze-dried formulation of MVA-BN smallpox vaccine. The three lots induced equivalent antibody responses, meeting the primary endpoint of the study. The favorable safety profile was also confirmed with no serious adverse reactions reported among the subjects.

Upon completion of the study, the company can submit a request to extend the approval for both formulations of MVA-BN. The extension would cover both the smallpox and the monkeypox indication.

“We are pleased to report positive results from the Phase 3 study, which is a significant step towards approval of the freeze-dried version of JYNNEOS and key to unlocking the future revenues from our existing supply contract with the U.S. government,” Paul Chaplin, president and CEO of Bavarian Nordic, said.

This project has been funded with federal funds from the HHS Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.