Bavarian Nordic Completes Smallpox Vaccine Phase 2 Trial in Vulnerable Population
Nordic A/S (NASDAQ OMX: BAVA) announced today that it has completed a
clinical Phase 2 trial of its smallpox vaccine, IMVAMUNE(R), in individuals
suffering from atopic dermatitis (a.k.a. eczema). These individuals are at
increased risk of severe side effects from conventional replicating smallpox
vaccines. Safety and immunogenicity data from the trial will be presented on
the American Academy of Dermatology.
Despite its eradication, bioterrorism experts are concerned about the
possibility of an attack on the U.S. that exposes the population to the
smallpox virus. The government currently stockpiles enough conventional
smallpox vaccine to protect the entire American public in the event of a
smallpox bioterrorism attack. However, these replicating smallpox vaccines
are not recommended and can cause severe complications for people with
compromised immune systems or atopic dermatitis. These rare but potentially
life threatening complications include progressive vaccinia, generalized
vaccinia, myo-/pericarditis and eczema vaccinatum.
In the Phase 2 trial, 350 individuals with mild to moderate atopic
dermatitis were vaccinated with IMVAMUNE(R), a non-replicating smallpox
vaccine. Adverse reactions and immune responses were compared to 282 healthy
subjects. Vaccination with IMVAMUNE(R) was well tolerated in both study
populations, and subjects with atopic dermatitis generated strong vaccinia
specific immune responses similar to healthy subjects.
Meeting the U.S. Government’s Need
The Department of Health and Human Services (HHS) highlighted the need to
protect vulnerable populations who are at increased risk of severe side
effects. In a 2010 Broad Agency Announcement for medical countermeasure
development, HHS specified a requirement for enough attenuated smallpox
vaccine “to protect 66 M [million] people, comprising those for whom smallpox
vaccine is contraindicated and their household contacts” including 10 million
immunocompromised and 28 million atopic dermatitis patients (Solicitation No.
The government is meeting only a portion of this requirement by
stockpiling 20 million doses of IMVAMUNE(R) for people with immune
deficiencies, in particular HIV. In 2010, Bavarian Nordic delivered more than
2 million doses of the vaccine. However, current government policy does not
allow these doses to be used for individuals with atopic dermatitis.
“The data from this trial strongly suggest that IMVAMUNE(R) is suitable
for individuals with atopic dermatitis,” said Bavarian Nordic President and
the next step of expanding the population it protects with this vaccine.”
Bavarian Nordic: An Established Biodefense Leader
Founded in 1994, Bavarian Nordic is a leading industrial biotechnology
company working to target unmet medical needs by developing and producing
vaccines for the prevention and treatment of life-threatening diseases. With
more than a decade of experience manufacturing smallpox vaccines and working
with the U.S. Government, Bavarian Nordic is a fully integrated
biopharmaceutical company with proven manufacturing and regulatory expertise.
For more information, visit
This study was funded in whole or in part with Federal funds from the
National Institutes of Health, National Institute of Allergy and Infectious
Diseases (Contract No. DMID-N01-AI-40072).
This announcement includes “forward-looking statements” that involve
risks, uncertainties and other factors, many of which are outside of our
control that could cause actual results to differ materially from the results
discussed in the forward-looking statements. Forward-looking statements
include statements concerning our plans, objectives, goals, future events,
performance and/or other information that is not historical information. We
undertake no obligation to publicly update or revise forward-looking
statements to reflect subsequent events or circumstances after the date made,
except as required by law.
SOURCE Bavarian Nordic A/S