Smallpox Vaccine

Government Expands Trial With IMVAMUNE(R) Smallpox Vaccine in Persons With Atopic Dermatitis/Eczema

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Anders Hedegaard, President & CEO of Bavarian Nordic, said, "We are very pleased that the U.S. Government has decided to extend the ongoing RFP-2 contract to include clinical studies in people with atopic dermatitis, one of the largest risk groups for experiencing adverse reactions associated with traditional smallpox vaccines. This is an important step in our efforts to develop a safe next-generation smallpox vaccine for the entire population, and it b.i.d. further on our long-term partnership with the U.S. Government."

The original RFP-2 contract, awarded in 2004 by NIAID, included a Phase II study with IMVAMUNE in persons diagnosed with atopic dermatitis. However the need for more clinical safety data in this population has increased due to requirements from the Food and Drug Administration (FDA) to generate data to support an Emergency Use Authorization (EUA) for IMVAMUNE.

Bavarian Nordic is the only company developing a new next-generation smallpox vaccine designed to be safe and effective for all persons, regardless of their health condition. In 2004, the company expanded its IMVAMUNE smallpox vaccine program to include persons diagnosed with atopic dermatitis. Results of Phase I studies have shown IMVAMUNE to be safe and well-tolerated in this population. The clinical development program has since progressed to a multi-center Phase II study in the USA and Mexico to investigate the safety and immunogenicity of IMVAMUNE in persons diagnosed with atopic dermatitis.

Atopic Dermatitis Prevalence and Smallpox Vaccination

A review by medical specialists investigating the risk to persons with atopic dermatitis for developing serious side effects from traditional smallpox vaccines, suggests that up to half of the U.S. population could be at risk to the vaccine. The authors note that the lifetime prevalence of atopic dermatitis is approximately 10%-15% of the population and estimate that the same amount of people has a history of the condition(s). They further project that it is probable that twice this amount of people have contact with others who have an active case or history of atopic dermatitis, suggesting the possibility that up to half of the population could be at risk to developing complications from vaccination with or exposure to traditional smallpox vaccines.(1)

The most recent report of accidental exposure to the smallpox vaccine was the highly-publicized case of a two-year-old boy with a history of eczema that developed a serious reaction after coming in contact with the vaccinia virus from his father's smallpox vaccination.(2)

Government Guidance - Atopic Dermatitis and Smallpox Vaccination

According to the Centers for Disease Control and Prevention (CDC) persons with atopic dermatitis as well as those who have had it in the past should not receive the current smallpox vaccine because of the risk of developing severe adverse reactions to the replicating virus found in the vaccine. Additionally, due to the risk of accidental exposure to the vaccine, persons with individuals in their households with atopic dermatitis are also advised not to be given the smallpox vaccine.(3)

Bavarian Nordic's new, patented developmental smallpox vaccine, IMVAMUNE(R), is based on the Modified Vaccinia Ankara (MVA) virus. In contrast to traditional smallpox vaccines, MVA is a live virus that does not replicate in human cells which means that the potential for adverse side effects are diminished and as a result does not pose a risk to others.

Keywords: Atopic Dermatitis, Bavarian Nordic GmbH, Biotechnology, Biotechnology Business, Biotechnology Company, Clinical Trial Research, Dermatology, Immunization, Regulatory Actions, Smallpox Vaccines, Vaccination, Smallpox Vaccine, Bavarian Nordic A/S.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.