Project BioShield

Medical Countermeasures for Smallpox

The Threat

Variola major Smallpox (Variola virus) is considered a high-priority biological threat agent.  It can be spread using an aerosol spray, transmitted from person to person via close contact, and can survive in the environment up to one day, depending on ambient conditions.  The fatality rate following infection is high, and there is no known effective treatment.  Vaccination obtained prior to 1972 (when routine vaccination for this disease ended in the U.S.) is considered unlikely to prevent disease, although it may decrease mortality following infection.  On September 23, 2004, the Secretary of Homeland Security determined that the smallpox virus is a material threat to the U.S. population sufficient to affect national security. The combination of the credibility of the threat and the potential for significant casualties and massive disruption of political, economic, and social infrastructures in the U.S. warrant strong efforts to reduce U.S. vulnerability to this threat.

HHS Smallpox Vaccine Stockpile

The Department of Health and Human Services (HHS) has made significant progress in providing smallpox vaccine to the Strategic National Stockpile (SNS).  The smallpox vaccine stockpile has grown from 90,000 ready-to-use doses in 2001 to enough vaccine to protect every man, woman, and child in America. The vaccine licensed in the United States, however, can have serious side effects for persons with impaired immune systems, such as some cancer patients, organ transplant recipients, and HIV-infected individuals.

Use of attenuated vaccinia viruses may reduce risk in those persons with impaired immune systems, because the attenuated viruses have a more limited capacity to reproduce and cause side effects.  Through research funded by the National Institute of Allergy and Infectious Diseases (NIAID), scientists successfully manufactured small amounts of a Modified Vaccinia Ankara (MVA) smallpox vaccine and conducted Phase I clinical trails 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 in progress 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. 

Project BioShield

On July 21, 2004, President George W. Bush signed into law the Project BioShield Act of 2004 (Project BioShield) as part of a broader strategy to defend the U.S. population against the threat of weapons of mass destruction.  The purpose of Project BioShield is to accelerate the research, development, purchase, and availability of effective medical countermeasures against the adverse health effects of chemical, biological, radiological, and nuclear (CBRN) agents.

In response to a requirement for next-generation smallpox vaccines, an interagency group of experts recommended an initial purchase of MVA vaccine.  The Secretaries of Health and Human Services and Homeland Security jointly recommended this acquisition and, following approval by OMB, HHS implemented it. 

On June 4, 2007, a contract utilizing the Special Reserve Fund was awarded to Bavarian Nordic of Copenhagen, Denmark to manufacture and deliver 20 million doses of a MVA smallpox vaccine.  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 (PAHPA).  Under BioShield, the company can get an advance payment based on a determination that it is necessary to the success of development, before delivery of product to the SNS. Under PAHPA, payments can be made upon achievement of milestone goals toward successful development, prior to delivery.