New bioterror vaccines are getting in the pipeline

All aimed at Category A’ agents

The federal government has awarded $232 million to fund research and development of new vaccines against three potential agents of bioterrorism: smallpox, plague, and tularemia. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will administer the contracts.

The funding responds to a key objective of the NIAID biodefense research agenda, which emphasizes the development of new and improved medical products against "Category A" agents — those considered by the Centers for Disease Control and Prevention (CDC) to pose the greatest threat to national security.

The smallpox awards continue advanced development work that began in February 2003 on two modified vaccinia Ankara (MVA) vaccine candidates. These contracts will support larger scale manufacturing of the vaccines as well as further safety and effectiveness studies in animals and humans. The tularemia and plague awards will fund early-stage product development of the respective vaccines, which will include dosage formulation, pilot batch production, and initial clinical assessment. All four contracts are for purchases of vaccine lots intended for research use. Any future purchases of additional vaccines for stockpiling in the event of an emergency will depend on the results of the research currently under way.

NIAID awarded two contracts totaling up to $177 million for advanced development of MVA vaccines against smallpox. The three-year contracts were awarded to Bavarian Nordic A/S of Copenhagen, Denmark, and Acambis Inc. of Cambridge, MA, and Cambridge, England. MVA is a highly weakened form of the vaccinia virus that cannot replicate in human cells.

Previous NIAID research has demonstrated that MVA is nearly as effective as the standard smallpox vaccine, making it a promising candidate for use in children and pregnant women as well as people with weakened immune systems or skin conditions such as eczema. The new contracts will allow the companies to continue the work they began under contracts awarded in February 2003.

For the plague vaccine, NIAID awarded a contract to Avecia Biotechnology Ltd. of Manchester, England. The three-year, $50.7 million contract covers the manufacture of a new plague vaccine as well as animal testing and initial human trials. There currently is no licensed plague vaccine, and the pneumonic form of the disease, which infects the lungs and can spread from person to person through the air, is nearly always fatal unless antibiotic treatment is started within 24 hours of infection.

NIAID also modified an existing contract with DynPort Vaccine Company LLC of Frederick, MD, to include the manufacture of a pilot batch of live, attenuated tularemia vaccine. The three-year, $4.5 million contract modification also covers stability testing of the vaccine. Tularemia is a highly infectious bacterial disease most often transmitted by ticks and insects.

In humans, illness is characterized by intermittent fever, headache, and swelling of the lymph nodes. This live, attenuated vaccine contains a weakened form of the tularemia bacterium, enabling the immune system to recognize and produce neutralizing antibodies against the bacterium if it is encountered again.