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Production of the vaccine under the new contract could begin as soon as December, and, once completed, will bring the total number of vaccine doses in the nation's stockpile to 286 million by the end of next year, enough to protect every United States citizen, if needed.

In light of increasing concerns regarding the possible use of biological agents such as smallpox in acts of terrorism or war, HHS is undertaking efforts to stockpile as much vaccine as needed to protect the nation in the event of an outbreak of smallpox.

"While the probability of an intentional release of the smallpox virus is low, the risk does exist and we must be prepared," Secretary Thompson said. "Expanding our stockpile so there is a smallpox vaccine for every American if needed prepares us to respond aggressively to minimize the spread of the disease should an outbreak occur. Additionally, we hope that increasing our smallpox vaccine stockpile would serve as a deterrent to those who might consider using smallpox as a weapon against us."

Acambis and Baxter will produce the smallpox vaccine using a purified strain of vaccinia virus grown in live tissue culture. Vaccinia virus is related to smallpox and stimulates immunity to the smallpox virus. The bulk vaccine will be produced in Baxter's production facility in Europe and will then be shipped to the U.S. for refinement and processing. The Food and Drug Administration will conduct a review of each vaccine production process along with testing of individual test lots of vaccine to assure the safety and effectiveness of the vaccine. The cost per dose of vaccine will be $2.76. The fixed-price contract protects taxpayers from any cost overruns, which would be borne by the manufacturer.

In addition to the 155 million-dose production announced today, other supplies of smallpox vaccine exist or are in development. The combination of the new contract with other supplies would bring the total number of doses in the smallpox vaccine stockpile to 286 million, and the new contract gives the federal government the option to purchase even more vaccine quickly.

An existing supply of 15.4 million doses of the "Dryvax" smallpox vaccine has been stored since production of the vaccine ended in 1983 and has retained its potency over this period of time. The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health has been studying the possibility of diluting this supply of vaccine by a ratio of 1 to 5 as a potential means of extending the supply. Early results indicate that the diluted vaccine retains the same level of effectiveness as the fully concentrated vaccine, which essentially will expand the existing Dryvax vaccine supply to at least 77 million doses. Researchers are also studying whether a 1 to 10 dilution retains the same level of effectiveness, as well.

In September 2000 the Centers for Disease Control and Prevention (CDC) awarded a contract to Acambis to produce a new supply of 40 million doses of smallpox vaccine by 2004. In September 2001 CDC renegotiated an accelerated production schedule with Acambis, in which the company agreed to increase its production to 54 million doses and deliver them by late 2002.

"These combined efforts will give us enough smallpox vaccine doses in our nation's stockpile to ensure every American will have a vaccine with his or her name on it, if needed," Secretary Thompson said.

In preparing for the possibility of a smallpox outbreak, the CDC has developed an interim smallpox response plan that outlines the essential public health strategies and approaches for responding to a smallpox emergency, including the use of smallpox vaccine.

The CDC plan does not call for mass vaccination of the U.S. population in advance of a smallpox outbreak. Based on what we know today, the risk of an outbreak of smallpox is substantially lower than the risk of serious complications from the vaccine.

According to the plan, rings of personal contacts, such as family members and co-workers, would be identified and then be vaccinated and monitored. This strategy, known as ring vaccination, is credited with helping to wipe out smallpox in the late 1970s and is still the most efficient approach today.

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). 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.

"Expanding our existing smallpox vaccine stockpile ensures that we are well prepared in the event of a bioterrorist attack using smallpox," said Dr. D.A. Henderson, director of the HHS Office of Public Health Preparedness and the person who led the WHO worldwide effort to eradicate smallpox. "This new contract gives us the insurance that we will have more than enough vaccine for any outbreak that might occur."

Smallpox symptoms include fever and a pock-like rash all over the body, appearing between seven and 17 days after exposure to the virus. People who are infected do not become contagious until the rash appears.

The foremost public health priority during a smallpox outbreak would be control of the epidemic. Doctors, health care workers and hospital personnel have been trained to identify infectious diseases, verify their diagnosis and then respond appropriately. The same system would identify any possible outbreak of smallpox.

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