“To protect ourselves from the remote but extremely grave threat of a deliberate release of smallpox virus, we need a vaccine that can be safely given to all Americans, including individuals with weakened immune systems, children and pregnant women,” said Secretary Thompson. “The new contracts will help us meet this need by accelerating research on second-generation smallpox vaccines.”
“Milestone-driven contracts such as these are one way NIAID is eliciting industry participation in the search for new and improved vaccines,” noted NIAID Director Anthony S. Fauci, M.D. “These programs are designed to get reliable products into the pipeline in an economically efficient and scientifically sound manner,” he added.
Acambis and Bavarian Nordic will develop, manufacture and conduct safety trials of modified vaccinia virus Ankara (MVA) vaccine candidates. Vaccinia virus, a close relative of smallpox virus, is used in traditional smallpox vaccines. A live, replicating virus, vaccinia can cause side effects, which on rare occasions can be serious and potentially life-threatening. Pregnant women and people with compromised immune systems, such as patients on chemotherapy or people with HIV/AIDS, cannot receive the current smallpox vaccine at all.
MVA is a strain of vaccinia that cannot replicate inside human cells and therefore cannot cause dispersed infection. An MVA-based vaccine given to more than 120,000 people during the smallpox eradication campaign in Germany in the 1970s had an excellent safety record. When smallpox was declared eradicated in 1980, however, the need for smallpox vaccines vanished, and research on MVA for that purpose ended.
Because of the urgent need for safer smallpox vaccines, the new contracts emphasize timely completion of predetermined objectives. For example, within the first six months the companies must produce several thousand doses of their prototype vaccine along with data indicating its effectiveness in animal models. Following approval of human study protocols, the companies will conduct tests of the vaccines’ safety in healthy adults. Finally, the companies must develop a plan for large-scale manufacture of the candidate vaccines and show how they could deliver up to 30 million doses to the federal government.
NIAID is a component of the National Institutes of Health (NIH), which is an agency of the Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.