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President Offers Smallpox Vaccine to All

Military, Medical Workers First; General Public Must Wait
By
WebMD Health News

Dec. 13, 2002 -- If you want a smallpox vaccination, you can get one -- but there's no current plan for a mass vaccination campaign for the general public, President Bush announced today.

Beginning in January 2003, the White House plan calls for key military and State Department personnel and emergency healthcare workers to get the first doses from the U.S. smallpox vaccine stockpile. Vaccinations for healthcare workers will be strictly voluntary. Those for the military will be required. The president says he, too, will get the vaccine.

"This particular vaccine does involve a small risk of serious health considerations," Bush says in his announcement. "As commander-in-chief, I do not believe I can ask others to accept this risk unless I am willing to do the same. Therefore I will receive the vaccine along with our military."

The plan has three phases. First, a half million members of the armed forces and another half million healthcare workers will get vaccinated. Next would come some 10 million emergency response workers: emergency-room workers, police, firefighters, and ambulance crews. The final phase -- offering the vaccine to anyone who wants it -- will occur as soon as the Department of Health and Human Services can work out a process for getting unlicensed vaccine in 2003 or licensed vaccine in 2004. In addition, citizens can sign up for clinical trials of a newer vaccine that is expected to be safer than the old one that is now in the national stockpile.

In case of a smallpox bioterror attack, the vaccine would be made widely available without licensing.

The U.S. smallpox vaccine stockpile now holds smallpox vaccine to cover every one of America's 288.6 million residents. Because old vaccine stocks can be diluted to stretch them out, there are about 75 million doses of the 1970s-era Dryvax vaccine and some 300 million doses of the 1950s-era Wetvax vaccine. Another 209 million doses of a modern smallpox vaccine will arrive soon.

Why not just offer everyone the vaccine right away? There are two issues. One is that the FDA has not had time to license every lot of the vaccine stockpile. The government could offer unlicensed vaccine under investigational new drug or IND rules. But these rules come wrapped in red tape. Everyone who wanted the vaccine would have to file a reason why they need it, creating mountains of paperwork.

The other issue is safety. In the U.S. in 1968, for example, some 14 million people received the vaccine. That year there were 572 bad reactions resulting in nine deaths. In those days, bad reactions were treated with serum from people who recovered from infection with the vaccine virus. This vaccinia immune globulin, or VIG, now is in very short supply.

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