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Bavarian Nordic Delivers 1 Million Doses of First Vaccine Developed Under U.S. Biopreparedness Program to the Strategic National Stockpile
Date:7/13/2010

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The U.S. Strategic National Stockpile includes stocks of conventional smallpox vaccines made from a live, replicating form of the vaccinia virus.  These vaccines were used in a global effort to wipe out the disease and resulted in worldwide eradication by 1980.

Conventional smallpox vaccines have been associated with high rates of serious adverse events, including death and severe disability. The 2003 U.S. smallpox vaccination program for health care workers, which involved more than 37,000 individuals, confirmed these severe side effects.

IMVAMUNE® (MVA-BN®) is a non-replicating smallpox vaccine derived from the modified vaccinia virus Ankara.  Since IMVAMUNE® does not have the ability to replicate in human cells, clinical trial data from 2,800 people in 15 ongoing or completed studies indicates that IMVAMUNE® has a favorable safety profile and is well tolerated, including in individuals with compromised immune systems who are currently not eligible for conventional smallpox vaccines.

BARDA highlighted the need to protect this vulnerable population in its 2010 Broad Agency Announcement for Medical Countermeasure Development, in which it noted the need for "attenuated smallpox vaccine - sufficient quantity to protect 66 M [million] people, comprising those for whom smallpox vaccine is contraindicated and their household contacts," which includes immunocompromised and atopic dermatitis patients.

About Bavarian Nordic's Contracts with the U.S. Government

Bavarian Nordic initiated the development of IMVAMUNE® in 1999 and began the first clinical study in 2001.  In 2003, Bavarian Nordic was awarded a contract, valued at $29 million, from the U.S. National Institutes o
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SOURCE Bavarian Nordic
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