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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

; is a non-replicating strain of vaccinia virus that, unlike conventional smallpox vaccines, does not have the ability to replicate in human cells, thereby eliminating risk of accidental infection.  Currently stockpiled smallpox vaccines are based on a replicating form of the vaccinia virus, and are therefore considered inappropriate for up to 25 percent of the population that may be immunocompromised or have other medical conditions that contraindicate a replicating viral vaccine.  While studies indicate that IMVAMUNE® is likely to be well tolerated in a broad population, it is currently being stockpiled for emergency use specifically in people with compromised immune systems, e.g. HIV/AIDS patients.

Mr. Hedegaard said the delivery authorization marks Bavarian Nordic's "transformation from a fledgling biotech to a fully-integrated research innovator with proven manufacturing and regulatory experience."  On March 17, FDA concluded that Bavarian Nordic has fulfilled all requirements to support the delivery of IMVAMUNE® to the U.S. Government.

The Need for a Non-Replicating Smallpox Vaccine

Security experts—including the U.S. Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism—expect that an act of biological terrorism is more likely than nuclear terrorism.  Compared to a nuclear weapon, a biological weapon is much cheaper to produce, the starting materials are more accessible, and less diversity of technological experience is required.  HHS considers smallpox a high-priority threat.

Because vaccination against smallpox is no longer standard, an increasing proportion of the population is unprotected and vulnerable to a bioterrorism attack.  Smallpox presents a continued global threat for which countries need to be prepa
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SOURCE Bavarian Nordic
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