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Friday November 2 1:14 PM ET

Planning Continues for Smallpox Vaccine Production

By Todd Zwillich

WASHINGTON (Reuters Health) - American vaccine makers are ''up to the effort'' of manufacturing 300 million doses of smallpox vaccine by the middle of next year, an industry representative told lawmakers on Friday.

But others are warning Congress to focus on shoring up the abilities of local health departments to respond to a serious bioterror attack.

The Department of Health and Human Services (news - web sites) has pared down its list of potential contractors from 10 to 4, and those companies are currently in negotiations to begin ramping up vaccine production, said Dr. Michael Friedman, chief medical officer for biomedical preparedness at the Pharmaceutical Research and Manufacturers of America, an industry trade group.

``This is an extraordinary effort. We are up to this effort,'' he told members of the Senate Appropriations Committee.

Moves to rapidly increase America's stores of smallpox vaccine are working on two main fronts--one in drug company labs making new vaccine and another in trials to see if existing stocks can be diluted while remaining effective.

The Bush administration has requested $509 million for procuring smallpox vaccine, though Congress has not yet acted on the proposal.

The US currently has 15.4 million doses of smallpox vaccine in stock. None has been manufactured over the last two decades.

Friedman said that Americans could expect 300 million vaccine doses--enough for everyone in the US--by ``the middle third quarter'' of the 2002 calendar year.

But that schedule was not fast enough for Sen. Arlen Specter (R-PA), who told companies and federal officials to ``go back to the drawing board'' to try to speed up vaccine production. ``The question is how fast can it be done...if money is not object,'' said Specter, the ranking member of the Senate Appropriations health subcommittee.

Public health officials argued that vaccine production is already working at capacity.

``I think we have pushed this system absolutely as much as we can,'' said Dr. James W. LeDuc, the head of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (news - web sites) in Atlanta, Georgia.

In addition to vaccine manufacturing, researchers are also conducting studies to see if antiviral drugs used to treat other infections might be effective as second-line backups in the case of a smallpox emergency. Scientists are testing cidofovir, a drug originally developed to treat cytomegalovirus infectious in AIDS (news - web sites) patients, said Dr. Anthony Fauci, the director of the National Institutes of Allergy and Infectious Diseases.

But local officials cautioned that Congress must also give high priority to state and local health departments as it considers emergency spending of up to $20 billion in the coming weeks.

``With smallpox, all the vaccine in the world isn't going to do any good without the capacity to distribute and administer vaccine locally,'' said Dr. Anita Barry, the communicable disease control director for the Boston Public (news - Y! TV) Health Commission in Massachusetts.

``And one thing is very clear: the current levels of staffing, planning and preparedness at the local level are not enough, even in cities that have initiated bioterrorism preparedness,'' she said.

Barry stressed that local departments [if not prepared to help doctors identify smallpox, while few have plans for how they will handle the surveillance, treatment and quarantine of potentially massive numbers of patients.

In Boston, ``we currently have one infectious disease physician and a few nurses,'' said Barry, who called on Homeland Security Director Tom Ridge to establish a commission of local health authorities to coordinate with federal officials on bioterrorism preparedness.

Lawmakers were sympathetic, noting that their proposals will spend between $2.3 billion and $3.1 billion on bioterrorism preparedness. Local health departments represent the ``front lines'' of any future bioterrorist attack, said Sen. Robert C. Byrd, a West Virginia Democrat who chairs the Appropriations Committee.

``If you put it in military terms, our troops are poorly trained, our radar is out of date, and we're low on ammunition,'' said Sen. Tom Harkin (D-IA), the health subcommittee chairman.

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World Health Body Rules Out Mass Smallpox Jabs (October 26)

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