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HHS Buys Next Generation Smallpox Vaccine

WASHINGTON, HHS Secretary Mike Leavitt announced today that HHS has awarded a contract for $500 million to Bavarian Nordic A/S of Copenhagen, Denmark to manufacture and deliver 20 million doses of a next generation modified vaccinia Ankara (MVA) smallpox vaccine.

The vaccine would be recommended in the event of a smallpox outbreak to protect people in the United States who have weakened immune systems. The full supply of the vaccine will be added to the Strategic National Stockpile, a reserve of large quantities of medicine and medical supplies to protect the American public if there is a public health emergency.

"To protect ourselves from the remote but extremely grave threat of a deliberate release of smallpox virus, we need vaccines that can be safely given to all Americans, including individuals with weakened immune systems," Secretary Leavitt said. "Acquiring a stockpile of this new smallpox vaccine is a key step toward protecting even more members of the American public against a smallpox release."

As part of HHS' comprehensive strategy to address the public health threat of a smallpox outbreak, the Strategic National Stockpile currently contains sufficient smallpox vaccine for every American. However, that vaccine supply was produced using vaccinia virus, a relative of smallpox virus. A live, replicating virus, vaccinia can cause side effects which, on rare occasions, can be potentially life-threatening. People with compromised immune systems, such as patients on chemotherapy or people with HIV/AIDS should not receive live, replicating smallpox vaccines in non-emergency situations.

The MVA smallpox vaccine contains a highly weakened form of the vaccinia virus that cannot replicate in humans. The MVA vaccine could be used in immunocompromised individuals, of whom there are an estimated 10 million in the U.S. In the event of a possible smallpox outbreak, the 20 million doses (the vaccine is being tested w ith a two-dose immunization schedule) of MVA vaccine purchased under this contract would be available to them.

This is the first BioShield contract to allow two types of advance (pre-delivery) payments -- one under the Project BioShield Act of 2004, and the other under the Pandemic and All-Hazards Preparedness Act of 2006. The contract also is the first under the Pandemic and All-Hazards Preparedness Act.

Under BioShield, the company can get an advance payment based on a determination that it is necessary to the success of the product. Under the Pandemic and All-Hazards Preparedness Act, the company can get payments as it reaches certain milestones in product development, before delivery of product to the Strategic National Stockpile.

"The use of these new authorities under the Pandemic and All-Hazards Preparedness Act further demonstrates our commitment to building improved partnerships with industry," Secretary Leavitt said.

This procurement builds upon the MVA smallpox vaccine research and development efforts initiated by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.

Through research funded by NIAID in 2003, scientists successfully performed small-scale manufacturing of the MVA vaccines and conducted Phase I clinical trials in healthy volunteers. These early development studies showed that MVA vaccine was safe and was able to stimulate an immune response in healthy volunteers. Large-scale manufacturing of the vaccine was subsequently performed. Several Phase II clinical studies are now either under way or planned, in healthy individuals and in individuals with weakened immune systems. The purpose of these studies is to further assess the safety of the vaccine, and also to begin to assess how effective the vaccine will be based on the immune responses generated.

The last case of smallpox occurred in the United States in 1949 , and the disease was declared eradicated worldwide in 1980 by the World Health Organization (WHO). However, there is concern that if terrorists obtained the virus, they could develop it as a weapon. Vaccinations to prevent smallpox have not been routinely administered in the United States since 1972, and people vaccinated prior to 1972 very likely have diminished immunity to smallpox.


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