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Smallpox

MVA-BN® freeze-dried

PHASE 3


As part of Bavarian Nordic’s contract framework with the US government on the development and supply of a non-replicating smallpox vaccine, an improved, freeze-dried formulation of the MVA-BN® smallpox vaccine is being developed.

During 2020, positive topline results from a Phase 3 lot-consistency trial of the freeze-dried formulation of MVA-BN were reported.

A prior Phase 2 study showed equivalence between the freeze-dried and liquid-frozen formulations of MVA-BN, and the lot-consistency trial was agreed with the FDA as the only Phase 3 study required to support licensure of the freeze-dried formulation.

The Phase 3 study evaluated the immunogenicity and safety of three consecutive vaccine lots in 1,129 vaccinia-naïve persons. The three lots induced equivalent antibody responses, meeting the primary endpoint of the study, while the favorable safety profile was in line with the cumulative safety experience of the approved liquid-frozen formulation. Upon successful completion of the current study, expected in 2021, the Company plans to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN, anticipated in 2022.

Although the World Health Organization (WHO) declared smallpox eradicated in 1980, this contagious and deadly disease remains high on the list of possible bioterror threats. Unique to humans, the disease is caused by the Variola virus and transmitted from person to person through direct contact with contaminated fluids and objects, as well as through the air. Historically, about 30% of those who became infected with smallpox died from the illness. There is currently no cure for the disease, vaccination is the only proven protection.

The U.S. government considers smallpox a material threat to national security. National security concerns are based on intelligence regarding previous biological weapons programs, coupled with the infectivity of the virus, an increasingly vulnerable population due to lack of immunity, and the relative ease of large-scale production. In fact, the U.S. Department of Defense has a mandatory smallpox vaccination program for troops being deployed to certain areas around the globe.

While the only known samples of smallpox are held at secure labs in the U.S. and Russia, the U.S. National Research Council found in a 2008 report that "the creation or acquisition of smallpox is well within the technical reach of a determined and well-resourced terrorist."

Given today's global travel and the virus' long incubation period, all nations must safe-guard against this virus. A smallpox outbreak anywhere could quickly become a global, not a local, problem.

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