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12 April 2002

Text: U.S., Canada Sign Smallpox Vaccine Agreement

Program will help protect military personnel against smallpox

The U.S. Department of Defense (DOD) and Canada's Department of National Defence (DND) have signed an agreement to jointly collaborate on a smallpox vaccine development program, according to a press release issued April 12 by the DOD.

"The program will develop and acquire a new smallpox vaccine based on a live viral (vaccinia) vaccine aiming to protect [U.S. and Canadian military] service members against the deadly disease," the DOD said, adding that the smallpox vaccine agreement "represents the first collaborative acquisition chemical-biological-radiological defense agreement between the two countries under a memorandum of understanding (MOU) that was signed in June 2000 by the United States, Canada, and the United Kingdom."

Joint Program Manager for Biological Defense U.S. Army Col. Stephen V. Reeves signed the international agreement along with Dr. John Leggat, Canadian assistant deputy minister (Science & Technology), DND, and CEO of Defence Research & Development, Canada.

"This agreement is very important to our national security interests and establishes a precedent between our two countries for future collaboration," said Reeves.

"Canadian Forces members must be capable of operating in environments where biological agents may be present and this program will enable us to meet the specialized needs for defensive medical countermeasures," said Leggat. "Participation in joint programs such as this one additionally enhances interoperability with our allies."

Following is the text of the DOD press release:

(begin text)

U.S. Department of Defense
April 12, 2002

NEWS RELEASE

UNITED STATES AND CANADA SIGN SMALLPOX VACCINE AGREEMENT

The Department of Defense (DoD) and Canada's Department of National Defence (DND) announced today that they have signed an agreement to jointly collaborate on a smallpox vaccine development program. The program will develop and acquire a new smallpox vaccine based on a live viral (vaccinia) vaccine aiming to protect service members against the deadly disease.

The smallpox vaccine agreement signed March 27, 2002, represents the first collaborative acquisition chemical-biological-radiological defense agreement between the two countries under a memorandum of understanding (MOU) that was signed in June 2000 by the United States, Canada, and the United Kingdom. The aim of the MOU is to further the goal of greater cooperation in research, development and acquisition of protective materiel against weapons of mass destruction leading to products common to allied forces.

Joint Program Manager for Biological Defense U.S. Army Col. Stephen V. Reeves signed the international agreement along with Dr. John Leggat, Canadian assistant deputy minister (S&T), DND, and CEO of Defence R&D Canada.

"This agreement is very important to our national security interests and establishes a precedent between our two countries for future collaboration," said Reeves.

The five-year advanced development effort takes the current DoD smallpox vaccine and vaccinia immune globulin (VIG), which is used to treat some adverse events through clinical trials and consistency lot production. The resulting data will be submitted to regulatory agencies of both countries (Food and Drug Administration and Health Canada) for joint licensure. Vaccine and VIG, produced as part of the licensing process, will become military stockpiles for both nations. Because these products will be licensed in both countries and labeled accordingly, they can be administered to warfighters from either nation and represent new medical interoperability in protection against biological warfare agents.

The agreement also provides for improved efficiency and effectiveness by allowing both countries to combine their financial and human resources, ultimately leading to reducing the cost of developing the same vaccines for use in both military populations.

"Canadian Forces members must be capable of operating in environments where biological agents may be present and this program will enable us to meet the specialized needs for defensive medical countermeasures," said Leggat. "Participation in joint programs such as this one additionally enhances interoperability with our allies."

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