Bavarian Nordic Announces a New Order for JYNNEOS Smallpox Vaccine from the U.S. Government Potentially Worth USD 200 Million - Seite 2

Paul Chaplin, President & CEO of Bavarian Nordic said: “We are very pleased to announce this new order for JYNNEOS, which shows the continued strong support and success of our public-private partnership with the US Government to supply biological countermeasures. As part of our commitment to supply vaccines to protect American citizens, we have invested more than USD 75 million in a state-of-the-art fill and finish facility, and with additional support from BARDA, we will be able to take control of the entire manufacturing cycle for both the liquid frozen and freeze-dried formulations of JYNNEOS and make this vaccine available to first-line responders for an improved preparedness against both smallpox and monkeypox.”

“While BARDA and the world focuses on the current coronavirus pandemic, other threats to national health security remain,” said BARDA Acting Director Gary Disbrow, Ph.D. “At BARDA, we are committed to meeting the needs of Americans and to engaging private partners in continually improving our nation’s security.”

About JYNNEOS
JYNNEOS is a suspension for subcutaneous injection (0.5 mL) based on a live, attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN), incapable of replicating in the body, yet still capable of eliciting a potent immune response. The vaccine was developed in partnership with the U.S. Government to ensure all populations can be protected from smallpox, including people with weakened immune systems or who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains. Typical severe adverse reactions known for replicating vaccinia virus strains, such as myocarditis, encephalitis, generalized vaccinia or eczema vaccinatum, were not observed during the clinical development program of JYNNEOS.

The approval of JYNNEOS for smallpox is based on a comprehensive development program, comprising a total of 7871 individuals aged 18 through 80 years who received at least 1 dose (7109 smallpox vaccine-naïve and 762 smallpox vaccine-experienced individuals) in 22 clinical trials, including two Phase 3 studies, the latter of which showed non-inferiority in terms of immunogenicity measured by plaque reduction neutralization test of JYNNEOS compared to ACAM2000, the other U.S. licensed, replicating smallpox vaccine.