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Saturday, February 27th, 2021

Bavarian Nordic completes Phase 3 enrollment for Imvamune smallpox vaccine study

Paul Chaplin

Bavarian Nordic A/S recently completed its enrollment of a Phase 3 clinical study designed to demonstrate non-inferiority between the company’s investigational, non-replicating smallpox vaccine called Imvamune and ACAM2000, the current U.S.-licensed and replicating smallpox vaccine.

The U.S. Food and Drug Administration supported two studies for the registration of liquid-frozen Imvamune. The first study, a lot consistency study of 4,000 healthy individuals, was completed in 2015.

“Completion of enrollment of this study represents a significant milestone in the collaboration between Bavarian Nordic, and multiple federal agencies,” said Bavarian Nordic President and CEO Paul Chaplin. “Imvamune has served as the cornerstone for our company over the past decade and we will continue to work with the U.S. government to meet their stated goal of protecting 66 million Americans who are in need of a safer smallpox vaccine. We look forward to reporting these data and working with the authorities in the process towards U.S. licensure.”

This Phase 3 non-inferiority study enrolled 440 individuals at a U.S. military garrison in South Korea and is led by the U.S. Army Medical Research Institute of Infectious Diseases in collaboration with the U.S. Defense Health Agency. The study is expected to be completed in the second quarter of 2017, with top-line data following in the second half of that same year.

In total, Bavarian Nordic has delivered 28 million doses of liquid-frozen Imvamune to the U.S. Strategic National Stockpile.

The the Denmark-based biotechnology company has developed a portfolio of vaccines for infectious diseases, including developing an Ebola vaccine with Janssen, which has been fast-tracked with the backing of global health authorities.